[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-injury":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,46,82,101,130,151,186,214,246,276,303,328,356,392,428,449,473,509,537,570,597,621,646,681,708],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100587617","paired-vagus-nerve-stimulation-in-mobilization-of-patients-with-prolonged-disorders-of-consciousness-100587617",false,"NCT06930716","Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness","Use of Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness: A Pilot Feasibility Study","Inclusion Criteria:\n\n* Patients with a diagnosis of pDOC (includes coma, VS\u002FUWS, MCS, MCS +, MCS-) as defined as disorder of consciousness (DOC) greater than 6 weeks post onset\n* Patients deemed medically safe to participate in physical therapy (PT) as evaluated by the study physicians.\n\nExclusion Criteria:\n\n* Patients who have emerged from MCS (CRS-R score 6 on Motor Function scale and\u002For 2 on Communication Scale).\n* Patients medically unsafe for participation in PT as indicated by one of the study physicians (including but not limited to those receiving intravenous sedation, those with integumentary breakdown or known pressure injuries, those with cardiovascular or cerebrovascular conditions precluding initiation of physical therapy \\[ie uncontrolled intracranial pressure, severe symptomatic orthostatic hypotension, etc.).\n* Patients with DOC less than 6 weeks post onset will also be excluded.\n* Patients who do not meet technical requirements of the RTTM device will be excluded\n\n  * weighing greater than 135 kg\n  * length of legs below 75 cm or above 100 cm,\n  * fixed contractures of lower extremity including hip, knee, ankle, or foot).\n* Does not have an identified care partner or legally authorized representative to consent to participation","ALL","22 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"NA","Prolonged disorders of consciousness (pDOC) are defined as DOC lasting \\>1 year post injury for patients with Traumatic Brain Injury (TBI) and \\>3 months post injury for patients with non-TBI and at present there are limited treatments that reliably lead to enhanced prognosis. The rehabilitation process throughout the continuum of care for patients with pDOC necessitates restorative strategies to facilitate arousal and functional recovery and coordinated medical management. Rehabilitation interventions for patients with DOC and pDOC have evolved in the past decade, with an emerging body of evidence highlighting the benefits of rehabilitation intervention even in the acute. While there is data to support the individual utility of these modalities, no work to date has investigated the benefits of pairing transauricular vagus nerve stimulation (taVNS) and robotic tilt table mobilization (RTTM) to maximize functional recovery in patients with pDOC. This study will report on the safety, feasibility, and preliminary short- and long-term outcomes of RTTM with simultaneously paired Transcutaneous auricular vagus nerve stimulation (taVNS) for Severe Acquired Brain Injury (SABI) patients with pDOC . Fifteen (15) participants will be recruited and complete a 12-week rehabilitation protocol using paired taVNS and RTTM. Once participants have been screened and enrolled in the study, they will complete three study phases: T1: a baseline observation of standard of care T2, intervention, and T3 longitudinal follow up.",[26,27,28],"Consciousness Disorders","Brain Injury","Altered Level of Consciousness",[30,31,32],"Therapy","Rehabilitation","Neuromodulation","RECRUITING","2026-06-16",{"date":36,"type":37},"2026-06-18","ACTUAL",{"date":39,"type":37},"2025-08-12",{"date":41,"type":20},"2027-12-30",{"name":43,"class":44},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":45},"100630260","fnirs-for-disorders-of-consciousness-100630260","NCT07485361","fNIRS for Disorders of Consciousness","Functional Near-infrared Spectroscopy in Disorders of Consciousness: Protocol Testing and Pilot in Neuro-ICU Setting","Inclusion Criteria:\n\nHealthy Control Participants:\n\n* Age 18 years or older\n* Proficient in English language\n* Intact cognition\n* Montreal Cognitive Assessment (MoCA) score \\> 26\n\nDoC Patients:\n\n* Age 18 years or older\n* Proficient in English language\n* Surrogate decision maker available\n* Admission to the intensive care unit within 28 days\n* Documented Glasgow Coma Scale (GCS) score\n* Auditory Function subscale score ≥1 on the Coma Recovery Scale-Revised (CRS-R)\n\nExclusion Criteria:\n\nHealthy Control Participants:\n\n* Known baseline hearing impairment without available hearing aids\n* Neurological or psychiatric history\n\nDoC Patients:\n\n* Known baseline hearing impairment without available hearing aids\n* Inability to obtain informed consent\n* Extensive bilateral frontal injury on available imaging (CT\u002FMRI)\n* Patients who have undergone craniectomy surgery\n* IV sedation in the past 24 hours\n* Absent auditory startle response (\\\u003C1 from Auditory Function subscale score of CRS-R)",true,"18 Years",{"count":56,"type":20},55,"OBSERVATIONAL","The goal of this observational study is to learn whether functional near-infrared spectroscopy (fNIRS) can measure brain activity in healthy adults and in people with disorders of consciousness (DoC) in the neuro-intensive care unit (Neuro-ICU). DoC include conditions such as coma and minimally conscious state that occur after severe brain injury. These conditions make it difficult to assess a person's level of awareness because many clinical tests rely on observable behaviors such as speaking or moving, which are commonly impaired after brain injury.\n\nThe main questions the study aims to answer are:\n\n* Can fNIRS detect changes in brain activity in healthy adults when they receive sensory stimulation or perform mental tasks?\n* Can the same fNIRS protocol be used in patients with disorders of consciousness in the Neuro-ICU to measure brain responses and determine whether the method is feasible in this clinical setting?\n\nThe investigators will first study healthy adult volunteers to establish baseline brain responses and determine which tasks produce the most reliable signals. The protocol will then be applied to patients with disorders of consciousness admitted to the Neuro-ICU.\n\nParticipants will take part in a single research session lasting about 30 to 45 minutes while wearing the lightweight fNIRS headband that measures brain oxygen levels using near-infrared light. During the session, participants will:\n\n* Wear a non-invasive fNIRS headband placed on the forehead\n* Receive gentle sensory stimulation (for example, compression devices on the legs or hands)\n* Listen to sounds or spoken sentences\n* Perform guided mental tasks such as imagining walking through their home or imagining moving a limb\n\nThe study does not test a treatment and will not change medical care. The goal is to determine whether fNIRS can safely and reliably measure brain activity at the bedside and provide preliminary information that may help guide future research on improving the assessment of consciousness after brain injury.",[60,61,62,63,64,27,65],"Disorders of Consciousness Due to Severe Brain Injury","Disorders of Consciousness","Coma","Minimally Conscious State","Unresponsive Wakefulness Syndrome","TBI Traumatic Brain Injury",[67,68,69,70,71,72],"Functional Near-Infrared Spectroscopy","Neurocritical Care","Functional Neuroimaging","Neuro Intensive Care Unit","Neurovascular Coupling","Consciousness Assessment","2026-06-04",{"date":75,"type":37},"2026-06-08",{"date":77,"type":37},"2026-05-01",{"date":79,"type":20},"2026-12",{"name":81,"class":44},"University of California, Los Angeles",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":4,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":98,"locationsCount":45},"100605589","intermediate-size-patient-population-expanded-access-protocol-to-evaluate-hb-admscs-for-the-treatment-of-patients-with-traumatic-or-nontraumatic-brain-injury-100605589","NCT07164482","Intermediate Size Patient Population Expanded Access Protocol to Evaluate HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury","\"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury\"","Inclusion Criteria:\n\n1. Male and female patients 14 - 78 years of age\n2. Patient should provide evidence of TBI or non -TBI as evidenced by documentation in their medical records and imaging that was done within the past 3 years.\n3. Female participants of childbearing potential should not be pregnant or plan to become pregnant during protocol participation and for 6 months after the last investigational product administration. Female participants of childbearing potential should confirm the use of one of the following contraceptive measures:\n\n   * Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).\n   * Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).\n   * Barrier contraceptive methods (condoms, diaphragm, etc.).\n   * Surgery (occlusion bilateral tubal ligation, hysterectomy, vasectomized partner).\n\n   OR\n\n   Male participants if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during protocol participation and for 6 months after the last administration of the investigated product:\n   * Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).\n   * Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).\n   * Barrier contraceptive methods (condoms, diaphragm, etc.).\n   * Surgery (vasectomy, occlusion bilateral tubal ligation (partner), hysterectomy (partner)).\n4. Patient\u002FLAR should be able to read, understand, and to provide voluntary consent.\n\nExclusion Criteria:\n\n1. Women who are currently pregnant or lactating.\n2. The patient has any active infection requiring medications per PI's discretion.\n3. The patient has any clinical signs or symptoms of infection per PI's discretion.\n4. The patient has hyperthermia or hypothermia.\n5. The patient has any known recent (within the last 6 months) coagulation anomalies that are not being medically treated and are not stable per PI's discretion.\n6. The patient has any abnormal laboratory values at the screening visit which the Investigator determines to be clinically significant and make the patient unsuitable for participation.\n7. The Investigator determines the patient to be unsuitable for participation for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, cardiac arrhythmia, or those who have a prothrombotic condition, or who require persistent oxygen supplementation.","14 Years","78 Years","EXPANDED_ACCESS","This expanded access protocol is part of IND 031942 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of nontraumatic or traumatic brain injury for up to 8 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the HBBI01 clinical study protocol entitled, \"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients with Traumatic or Nontraumatic Brain Injury.\" under IND 027396.",[27],"AVAILABLE","2026-05-15",{"date":97,"type":37},"2026-05-19",{"name":99,"class":100},"Hope Biosciences Research Foundation","INDUSTRY",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":112,"conditions":113,"keywords":119,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":45},"100578364","early-phase-1-pain-control-and-quality-of-recovery-after-intravenous-methadone-versus-intravenous-remifentanil-in-craniotomy-surgery-100578364","NCT06810336","Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery","Inclusion Criteria:\n\n1. Adult Patients between ages 18 and 65 years old.\n2. Undergoing supratentorial intracranial surgery\n3. American Society of Anesthesiologists (ASA) physiological status I-III\n4. Body Mass Index (BMI) between 18.5 and 45\n5. Ability to understand and read English\n\nExclusion Criteria:\n\n1. Being unable or unwilling to sign a consent\n2. Anticipated discharge within 24 hours after surgery\n3. Patients requiring Emergent Surgery\n4. Preoperative usage of Methadone, or allergy to it.\n5. Patients with chronic pain, requiring daily opioid use at the time of surgery, MME \\>60 as FDA defines opioid tolerant as 60 MME, long-acting forms of opioids such as fentanyl patch, oxycontin\n6. Active or Prior Substance Use Disorder, undergoing active treatment with Medication of Opioid Use Disorder including methadone (once daily dosing), Buprenorphine (any formulation) and Naltrexone\n7. Preoperative chronic renal insufficiency or failure (defined as a serum creatinine more than 2 mg\u002Fdl),\n8. Pregnancy\n9. Significant liver disease (cirrhosis or hepatic failure)\n10. QTc \\>450 on preoperative electrocardiogram\n11. Pulmonary disease necessitating home oxygen therapy\n12. Inability to speak or read the English language","65 Years",{"count":109,"type":20},40,[111],"EARLY_PHASE1","Postoperative pain is prevalent after intracranial surgery. Patients undergoing craniotomy are typically managed with short acting opioids to enable early and reliable post-operative neurological exam as well as avoid the risk of respiratory depression. However, a plethora of studies have shown that a majority of these patients experience moderate to severe pain in first 48 hours after surgery. Suboptimal pain control can lead to complications such as arterial hypertension and post-operative intracranial hemorrhage, and hence, increased morbidity and mortality.\n\nIntravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery. Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery and received IV methadone intraoperatively.\n\nIn a recently published retrospective study, a single intraoperative dose of IV methadone was well tolerated with lower pain scores as well as MME (oral morphine milligram equivalents) requirements for up to 72 hours after elective intracranial surgery.\n\nIV methadone has, however, never been compared with conventional management via IV remifentanil for functional recovery in patients undergoing elective intercranial surgery.\n\nThe investigator's hypothesis is that intravenous (IV) methadone is non-inferior to IV remifentanil in patients who undergo elective intracranial surgery. It offers the advantage of being a single dose noninvasive analgesic modality that may contribute to decreasing MME consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery.",[27,114,115,116,117,118],"Brain Tumors","Craniotomy Surgery","Pain","Postoperative","Postoperative Care",[120],"craniotomy","2026-04-27",{"date":123,"type":37},"2026-05-04",{"date":125,"type":37},"2025-03-10",{"date":127,"type":20},"2027-09-10",{"name":129,"class":44},"University of Virginia",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":54,"enrollmentInfo":136,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":45},"100585254","the-association-between-tau--gfap-and-postoperative-neurological-impairment-in-patients-undergoing-cardiac-surgery-100585254","NCT06899971","The Association Between Tau & GFAP and Postoperative Neurological Impairment in Patients Undergoing Cardiac Surgery","Inclusion Criteria:\n\n* less than 18 years old\n* undergoing cardiac surgery with cardiopulmonary bypass at Boston Children's Hospital\n\nExclusion Criteria:\n\n* undergoing an emergent procedure and do not have more than 1 hour ahead of time to review the consent\n* patient in a moribund condition American Society of Anesthesiology (ASA 5)\n* patient with a hematological and\u002For oncological disease\n* Jehovah witnesses\n* patient on preoperative mechanical ventilation",{"count":137,"type":20},100,"Patients born with heart defects often undergo surgical procedures on a heart lung machine. With improvements in medical and surgical management, their survival has significantly improved, but their brain insult has not been paid much attention. This study is to determine the relationship between specific proteins in the blood and brain injury in patients less than 18-year-old undergoing heart surgery.",[140,27,141],"Cardiac Surgery Requiring Cardiopulmonary Bypass","Congenital Heart Defect","NOT_YET_RECRUITING","2026-03-16",{"date":145,"type":37},"2026-03-17",{"date":77,"type":20},{"date":148,"type":20},"2027-12-31",{"name":150,"class":44},"Boston Children's Hospital",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":168,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100618415","the-coma-family-program-coma-f-a-resilience-program-for-caregivers-of-patients-with-severe-acute-brain-injury-100618415","NCT07331324","The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury","The Coma Family Program (COMA-F): A Multi-site Clinical Trial of a Resilience Program for Caregivers of Patients With Severe Acute Brain Injury","COMA-F","Inclusion Criteria:\n\n1. 18 years or older - study population\n2. English fluency and literacy - measures and intervention are in English\n3. Screens positive for emotional distress on either depression or anxiety subscales (\\>7) of the Hospital Anxiety and Depression scale - study population (caregivers must be at-risk for chronic distress via heightened acute distress)\n4. Confirmed by the clinical team as the primary caregiver of a patient who has been admitted to an intensive care unit (ICU) with a severe acute brain injury with the following characteristics:\n\n   1. 18 years or older - study population\n   2. Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population\n   3. Glasgow Coma Scale score below 9 (in judgement of the clinical team) while not intubated or an inability to follow meaningful commands while intubated at any point during the hospitalization for \\> 24 consecutive hours due to the brain injury itself and not a confounding factor (e.g., sedation or seizures) - study population\n   4. Still alive in ICU at the time the clinical team approaches the caregiver about possible recruitment - excludes caregivers of those that passed away as would require a different intervention (e.g., grieving intervention)\n   5. Has been committed to or has already received long-term life-sustaining treatments including tracheostomy and\u002For percutaneous endoscopic or surgical gastrostomy tube placement (trach or PEG) - study population; at time of enrollment patients can be in various early stages of cognitive\u002Ffunctional recovery from initial coma, but all were severe enough to require trach and\u002For PEG\n   6. Has a prognosis for survival of greater than 3 months and does not have a concurrent diagnosis of a terminal illness or injury as judged by the clinical team - as in \"d\"; such caregivers would require different intervention\n   7. Is still in ICU or has been transferred to a lower level of care (e.g., stepdown) for \\\u003C7 days at the time of consent - study population; we aim to begin the intervention when caregivers are acutely distressed in the context of the patient's ICU stay or shortly after the ICU stay (i.e., within 7 days of leaving)\n\nExclusion Criteria:\n\n* 1\\. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care",{"count":160,"type":20},150,[23],"The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.",[164,165,166,167,62,27],"Caregiver Distress","Emotional Distress","Caregivers","Resilience",[169,170,171,172,173,174,175],"caregivers","emotional distress","caregiver burden","resilience","coma","severe acute brain injury","mindfulness","2026-02-18",{"date":178,"type":37},"2026-02-20",{"date":180,"type":20},"2026-05",{"date":182,"type":20},"2030-12",{"name":184,"class":44},"Massachusetts General Hospital",3,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":201,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":45},"100621487","effects-of-virtual-reality-with-multisensory-stimulation-on-emotional-and-behavioral-disorders-in-individuals-with-acquired-brain-injury-and-disability-requiring-institutional-care-a-single-case-experimental-design-sced-study-100621487","NCT07371260","Effects of Virtual Reality With Multisensory Stimulation on Emotional and Behavioral Disorders in Individuals With Acquired Brain Injury and Disability Requiring Institutional Care: a Single Case Experimental Design (SCED) Study.","Rév In MAS","Inclusion Criteria:\n\n* Resident aged over 18\n* Diagnosis of stroke, traumatic brain injury, tumor, or cerebral anoxia for more than 3 years.\n* Living in a nursing home for at least 6 months\n* Presence of one or more emotional and behavioral disorders during initial assessments (NPI-ES) for at least 3 months.\n* Sufficient cognitive abilities to understand instructions and answer questions using a Likert scale.\n* Normal or corrected visual acuity\n* Resident affiliated with the social security system\n\nExclusion Criteria:\n\n* Motor or sensory disorders incompatible with the use of VR\n* Unstabilized photosensitive epilepsy or presence of a seizure in the past year\n* Change in the prescription of neuroleptic treatments, antidepressants, benzodiazepines, sedatives, anxiolytics, mood stabilizers, antiepileptics, or betablockers within the last 3 months.\n* Unstabilized major psychiatric disorders.\n* Craniectomy\n* Limited range of cervical movement due to orthopedic disorders\n* Moderate or severe hearing loss not compensated by a hearing aid\n* Anosmia\n* Asthma\n* Pregnant women or women suspected of being pregnant\n* Breastfeeding women\n* Neurocognitive disorders preventing understanding of instructions during assessments\n* The resident is included in another research protocol",{"count":185,"type":20},[23],"Acquired brain injuries (ABIs) frequently cause emotional and behavioral disorders that impair independence and quality of life, particularly in institutions. Virtual reality (VR), already used in various mental and neurological disorders, offers therapeutic potential that remains largely unexplored in this context.\n\nMultisensory devices offer enhanced immersion that can potentially increase the relaxation and calming effect. Their use in specialized care home (SCH) could provide additional support for care.\n\nThe main objective of the study is to measure the effect of an 8-week multisensory VR relaxation program on the most significant emotional and behavioral disorders in adults with acquired brain injury living in SCH. The SCED method with multiple baselines across subjects (ABA) is used with three adult residents with ABCI and behavioral disorders living in SCH. The study consists of three phases (baseline, intervention, follow-up), during which the three main emotional and behavioral disorders of each resident are assessed weekly based on observations made throughout the week. Additional measures include the assessment of the socio-emotional profile by the care team (ECCSEG) and the emotional distress experienced by residents (QOLIBRI), collected twice per phase. The intervention consists of eight weeks of VR relaxation (VirtySens®), with two 15-minute sessions per week.\n\nAll measurements taken during the experiment will be anonymized and used only by the investigators, who are fully aware of the European GDPR (General Data Protection Regulation) concerning the protection of personal data.",[27,197,198,199,200],"Virtual Reality","Behavior","Emotion","Well-being",[202,198,199,200,197,203,204],"Acquired Brain Injury","Multisensory","Specialized Care Home","2026-01-19",{"date":207,"type":37},"2026-01-27",{"date":209,"type":20},"2026-02-15",{"date":211,"type":20},"2027-02-01",{"name":213,"class":44},"Hopital La Musse",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":45},"100617303","neuroprotective-effect-of-mild-hypothermia-versus-normothermia-during-cardiopulmonary-bypass-of-coronary-artery-surgery-100617303","NCT07316868","Neuroprotective Effect of Mild Hypothermia Versus Normothermia During Cardiopulmonary Bypass of Coronary Artery Surgery","Neuroprotective Effect of Mild Hypothermia as Compared With Normothermia During Cardiopulmonary Bypass of Coronary Artery Bypass Grafting - A Single-center Randomized Controlled Trial","HYPNOCABG","Inclusion Criteria:\n\n1. Informed consent obtained\n2. Age of \\>18 years\n3. Undergoing elective or subacute coronary artery bypass grafting\n\nExclusion Criteria:\n\n1. An emergency case\n2. A history of stroke\n3. A history of intracranial bleeding\n4. A history of transient ischemic attack (TIA)\n5. A history of neurodegenerative diseases such as Alzheimer's, multiple sclerosis\n6. The subject is known to have a clinically significant laboratory abnormality, medical condition (such as decompensated liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator's opinion, makes it inappropriate for the subject to participate in this clinical trial.\n7. Presence of implants or foreign bodies which are not known to be MRI safe",{"count":223,"type":20},160,[23],"In high-income countries, coronary artery bypass grafting (CABG) remains a common procedure, with approximately 36.7 operations per 100,000 inhabitants annually, corresponding to about 136,000 procedures in the European Union. This highlights the substantial healthcare burden and the need to optimize surgical outcomes. Cardiopulmonary bypass (CPB) is a fundamental component of cardiac surgery, ensuring extracorporeal perfusion of vital organs.\n\nHypothermic CPB has historically been widely used for organ protection due to its presumed neuroprotective mechanisms. However, evidence demonstrating its superiority over normothermic CPB remains inconclusive. In its 2024 guidelines, the European Association for Cardio-Thoracic Surgery recommends considering normothermia (≥35 °C) to reduce postoperative neurocognitive dysfunction (Class II, Level A). This recommendation is primarily based on two meta-analyses, but the underlying studies show methodological heterogeneity, outdated practices, and limited applicability to contemporary cardiac surgery. Importantly, the guidelines acknowledge the need for large randomized controlled trials to define optimal target temperature management (TTM) during CPB.\n\nPrevious diffusion-weighted MRI studies have demonstrated silent ischemic brain lesions in approximately 30% of CABG patients, with postoperative neurocognitive decline occurring in a similar proportion. However, no significant differences have been shown between normothermic and hypothermic CPB. Diffusion tensor imaging (DTI) extends conventional diffusion imaging by enabling detailed assessment of white matter microstructure and tractography. Fractional anisotropy (FA), a key DTI metric, has demonstrated prognostic value in various neurological conditions but has not yet been applied in CABG patients.\n\nBlood-based biomarkers, including glial fibrillary acidic protein, neurofilament light chain, neuron-specific enolase, and total tau, offer complementary insights into brain injury but have not been studied in combination with DTI in this population.\n\nThis study will compare mild hypothermic (33-34 °C) and normothermic (36.5 °C) CPB to evaluate their neuroprotective effects using advanced MRI techniques and blood-based biomarkers. The primary aim is to determine whether mild hypothermia provides superior neuroprotection following CABG. Secondary objectives include assessing white matter injury evolution, global ischemic burden, associations with biomarkers and neurocognitive decline, and developing integrated prognostic models to improve outcomes in CABG patients.",[227,27],"Coronary Artery Disease",[229,230,231,232,233,234,235],"hypothermia","normothermia","cardiopulmonary bypass","coronary artery bypass grafting","diffusion tensor imaging","neuroprotection","biomarkers","2025-12-18",{"date":238,"type":37},"2026-01-05",{"date":240,"type":20},"2026-01-01",{"date":242,"type":20},"2029-12-31",{"name":244,"class":245},"Turku University Hospital","OTHER_GOV",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":257,"conditions":258,"keywords":260,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":45},"100476040","innovative-multimodal-and-attention-training-to-improve-emotion-communication-in-veterans-with-tbi-and-ptsd-100476040","NCT05478759","Innovative Multimodal and Attention Training to Improve Emotion Communication in Veterans With TBI and PTSD","Inclusion Criteria:\n\n* Veterans with a diagnosis of mTBI and PTSD based on VA\u002FDepartment of Defense guidelines.\n* Emotion recognition deficit\n* Attention deficit\n* Corrected vision within normal limits\n* Hearing within normal limits\n* Fluent in English\n\nExclusion Criteria:\n\n* premorbid history of schizophrenia\n* bipolar disorder\n* chronic medical or neurological diseases","25 Years","50 Years",{"count":255,"type":20},20,[23],"Poor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Currently there are no interventions for emotion recognition in Veterans with mTBI and PTSD, and interventions for severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise but lacked attention training that is an essential component in recognizing emotions in our daily lives. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a study is needed to determine the effectiveness of a MMART combined with attention training.",[27,259],"Post Traumatic Stress Disorder",[261,262,263,264,265],"cognition","intervention","brain injury","emotion recognition","post traumatic stress disorder","2025-12-17",{"date":268,"type":37},"2025-12-24",{"date":270,"type":37},"2022-12-01",{"date":272,"type":20},"2026-06-30",{"name":274,"class":275},"VA Office of Research and Development","FED",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":283,"minAge":54,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":286,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":45},"100592081","multifaceted-intervention-to-restore-resilience-and-overcome-risk-100592081","NCT06988787","Multifaceted Intervention to Restore Resilience and Overcome Risk","MIRROR","Inclusion Criteria:\n\n* Able to consent as determined by UBACC, are English-speaking FVets who are 18+ years old\n* Screen positive for exposure to IPV and\u002For MST using the VA Intimate Partner Violence Assistance Program (VA IPVAP) and MST Screening Protocol,\n* Have a history of at least one BI assessed using the BISQ+IPV,\n* Sub-threshold PTSD (operationalized as a total score of \\>33 on the PTSD Checklist Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5),\n* Report deficits in Emotion Regulation (operationalized as a score of 0.5 SD above published means on the DERS).\n\nExclusion Criteria:\n\n* FVets at high risk for suicide (respond yes to items 3, 4, 5, or 8 on the Columbia Suicide Severity Rating Scale \\[C-SSRS\\]),\n* Observable active psychosis (e.g., auditory hallucinations, grandiose delusions),\n* Those determined to have problematic substance use (score \\> 27 on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) will be referred to substance use dependence programs for concurrent treatment. The PI and Co-Is will collaborate with the substance use dependence program to determine continued participation.","FEMALE",{"count":285,"type":20},136,[23],"The MIRROR study will compare the effectiveness of two interventions in improving emotion regulation and reducing PTSD symptoms in female Veterans with military sexual trauma (MST) and\u002For intimate partner violence (IPV) and co-occurring brain injury.",[289,290,27,259],"Military Sexual Trauma","Intimate Partner Violence",[289,290,292,293,27,294],"Female Veterans","Emotion Regulation","Exposure Therapy","2025-12-03",{"date":297,"type":37},"2025-12-10",{"date":299,"type":37},"2025-09-12",{"date":301,"type":20},"2028-08-01",{"name":43,"class":44},{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":310,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":21,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":45},"100468459","comparing-telehealth-to-in-person-a-combined-metacognitive-training-in-veterans-with-mtbiptsd-100468459","NCT05380050","Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI\u002FPTSD","Comparing the Effectiveness of Telehealth to In-person Delivery of a Combined Metacognitive and Attention Training in Veterans With mTBI\u002FPTSD","Inclusion Criteria:\n\n* Veterans who have served in OIF-OEF-OND and have been diagnosed with both a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on the joint criteria of the Veterans' Affairs and Department of Defense (VA \\& DoD).\n* Latest mTBI occurred at least 6 months prior to study enrollment.\n* Attention deficit of 1.5 SD below the mean of the RBANS attention index.\n* Family member or friend that is willing to complete a questionnaire.\n* Access to a home computer, or smartphone with internet access.\n\nExclusion Criteria:\n\n* History of pre-morbid learning disability.\n* History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.\n* Neurological disease unrelated to TBI (seizure disorder, stroke).\n* Score \\\u003C 90 on National Adult Reading Test (NART).\n* Failure of validity testing on the Test of Memory Malingering (TOMM).\n* Reported alcohol or substance abuse within the past year.\n* Reported involvement in current litigation related to injury.\n* Recent change of medications for seizures, depression, or memory.\n* Currently enrolled in other cognitive therapy that cannot be discontinued.\n* Does not speak English fluently.\n* Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).\n* Uncontrolled, acute medical or psychiatric condition as indicated by the participant or observed by the research team member that would make it unsafe to participate in the research activities, i.e. precautions for active homicidal\u002Fsuicidal intent, active psychosis, or acute symptoms requiring immediate medical attention.","30 Years","55 Years",{"count":313,"type":20},63,[23],"Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI\u002FPTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.",[27,317,318,319],"Cognition","PTSD","Intervention","2025-10-16",{"date":322,"type":37},"2025-10-21",{"date":324,"type":37},"2022-11-01",{"date":326,"type":20},"2026-10-31",{"name":274,"class":275},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":21,"phases":338,"briefSummary":339,"conditions":340,"keywords":345,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":354,"locationsCount":45},"100591364","q-therapeutic-system-for-chronic-stroke-recovery-100591364","NCT06979466","Q Therapeutic System for Chronic Stroke Recovery","Facilitation Recovery For Patients With Chronic Stroke: The Q Therapeutic System, Frequency-Tuned Electromagnetic Field Treatment","EMAGINE-C","Inclusion Criteria:\n\n* FMA-UE score between 22-50 (inclusive) of impaired limb.\n* Difference between Screening and Baseline visit FMA-UE is 3 points or fewer.\n* Age 18 to 80 years of age (inclusive).\n* Stroke due to ischemia or to intracerebral hemorrhage.\n* \\>6 months to 5 years from index stroke onset.\n* Box \\& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.\n* Able to sit with the investigational System for 40 consecutive minutes.\n* Can follow a 3-step command, such as \"take the paper, fold it in half, and return it to me\", or a non-verbal equivalent.\n* Willingness to participate in physical exercises during study intervention sessions.\n* Availability of a relative or other caregiver able to assist during study treatment sessions and visits.\n* If female, not pregnant or breastfeeding or planning pregnancy during the study period.\n* Informed consent signed by subject.\n\nExclusion Criteria:\n\n* Severe neglect impairment interfering with assessments or treatments.\n* Severe depression, defined as GDS Score \\>10\u002F15\n* The presence of MR-incompatible implanted devices or MR-incompatible retained objects; or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator).\n* Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years\n* Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit\n* Severe UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis\n* Pre-existing neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and\u002For confound neurological or functional evaluation.\n* Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and\u002For confound neurological or functional evaluation.\n* Unstable serious illness\u002Fcondition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.\n* Alcohol abuse and\u002For illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.\n* Participation in another interventional trial that would conflict with the current study or clinical endpoint interference may occur.\n* Participation in an upper extremity rehabilitation program provided by a licensed provider in the 4 weeks prior to the Screening visit, or a or planned participation in such program at any time between the Screening Visit and the primary endpoint visit.\n* Employee of the Sponsor.\n* Prisoner.","80 Years",{"count":5,"type":20},[23],"Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.",[341,342,27,343,344],"Stroke","Hemorrhage","Cerebrovascular Accident (CVA)","Chronic Stroke Patient",[346,341,347,348],"BrainQ","Cerebrovascular Disorders","Electromagnetic Stimulation","2025-08-07",{"date":39,"type":37},{"date":352,"type":37},"2025-05-26",{"date":272,"type":20},{"name":355,"class":44},"Burke Rehabilitation Hospital",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":367,"briefSummary":368,"conditions":369,"keywords":376,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":45},"100573513","early-phase-1-feasibility-and-safety-of-intranasally-administered-breast-milk-in-hie-100573513","NCT06747260","Feasibility and Safety of Intranasally Administered Breast Milk in HIE","Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy","F-NEO-BRIGHT","Inclusion Criteria:\n\n* Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia\n* ≥ 35. gestational week\n* \\\u003C 48 hours of life\n* Hypothermia treatment for 72 hours\n* Parental consent form\n\nExclusion Criteria:\n\n* Congenital malformation\n* Concurrent cerebral lesions\n* ECMO therapy\n* Contraindication of lactation\n* Mother unable or unwilling to provide fresh breast milk\n* Postpartum asphyxia","48 Hours",{"count":366,"type":20},10,[111],"This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.",[370,371,372,373,27,374,375],"Hypoxic Ischaemic Encephalopathy (HIE)","Hypoxic Ischemic Encephalopathy of Newborn","Neonatal Encephalopathy","Neonatal Hypoxic Ischemic Encephalopathy","Perinatal Asphyxia","Perinatal Asphyxia , Moderate to Severe HIE",[377,378,379,380,381,382],"Hypoxic-ischaemic encephalopathy","Neonatal encephalopathy","Perinatal asphyxia","Breast milk","Breast milk stem cells","Intranasal breast milk","2025-05-19",{"date":385,"type":37},"2025-05-22",{"date":387,"type":37},"2024-11-22",{"date":389,"type":20},"2030-01-01",{"name":391,"class":44},"Semmelweis University",{"id":393,"slug":394,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":21,"phases":402,"briefSummary":403,"conditions":404,"keywords":408,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":45},"100469827","biofeedback-for-hemianopia-vision-rehabilitation-100469827","NCT05397873","Biofeedback for Hemianopia Vision Rehabilitation","Biofeedback Training to Improve Fixation Stability, Visual Function Outcomes, and Quality of Life in Hemianopia Cases","Inclusion Criteria:\n\n* hemianopia cases previously diagnosed accordingly by microperimetry and other tests as needed\n* 18-90 years old\n* ability to follow the visual and auditory stimuli and training instructions\n\nExclusion Criteria:\n\n* previous or current treatment for low vision rehabilitation\n* ocular diseases\n* other serious clinical conditions not related to the hemianopia physiopathology\n* both eyes with media opacity that impairs microperimetry testing\n* lack of ability to perform the tests and training","90 Years",{"count":401,"type":20},32,[23],"Patients with brain injury secondary to stroke, surgery, or trauma frequently suffer from homonymous hemianopia, defined as vision loss in one hemifield secondary to retro- chiasmal lesion. Classic and effective saccadic compensatory training therapies are current aim to reorganize the control of visual information processing and eye movements or, in other words, to induce or improve oculomotor adaptation to visual field loss. Patients learn to intentionally shift their eyes and, thus, their visual field border, into the area corresponding to their blind visual field. This shift brings the visual information from the blind hemifield into the seeing hemifield for further processing. Patients learn, therefore, to efficiently use their eyes \"to keep the 'blind side' in sight\". Biofeedback training (BT) is the latest and newest technique for oculomotor control training in cases with low vision when using available modules in the new microperimetry instruments. Studies in the literature highlighted positive benefits from using BT in a variety of central vision loss, nystagmus cases, and others.The purpose of this study is to assess systematically the impact of BT in a series of cases with hemianopia and formulate guidelines for further use of this intervention in vision rehabilitation of hemianopia cases in general.",[405,27,341,406,407],"Hemianopsia, Homonymous","Brain Tumor","Brain Trauma",[409,410,411,412,413,414,415,416,417,418],"hemianopsia","stroke","brain tumor","brain trauma","visual fields","visual loss","low vision","fixation stability","biofeedback training","MAIA microperimeter","2025-05-05",{"date":421,"type":37},"2025-05-09",{"date":423,"type":37},"2021-12-01",{"date":425,"type":20},"2026-07",{"name":427,"class":44},"University Health Network, Toronto",{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":447,"locationsCount":45},"100587607","prognostic-value-of-neurometabolic-networks-in-crc-pvnm-crc-100587607","NCT06930586","Prognostic Value of Neurometabolic Networks in CRC (PVNM-CRC)","An Observational Study on the Prognostic Value of Neurometabolic Networks in Colorectal Cancer","PVNM-CRC","Male\u002FFemale subjects with rectal cancer of at least 18 years of age will be enrolled in this trial.",{"count":437,"type":20},213,"Colorectal cancer (CRC), with annually increasing incidence and mortality worldwide, has become the second leading cause of cancer-related death. The development of CRC often follows the canonical normal-adenoma-carcinoma (N-A-C) sequence driven by progressive accumulation of molecular genetic events, highlighting the importance of early detection and removal of precancerous lesions. However, some patients who have had adenomas removed still have a high risk of developing new adenomas or CRC, especially for those with chronic or systemic disease, indicating that a compositive regulatory network is involved in the tumorigenesis of CRC. Additionally, despite advances in therapeutic strategies having improved the prognosis of CRC patients, tumor metastasis continues to be the predominant cause of mortality. These suggest the need to transcend limitations focusing solely on intertumoral microenvironment or single-timepoint event but adopt a more systemic perspective to elucidate the mechanisms underlying the whole sequence of CRC development and progression.\n\nThe gastrointestinal (GI) tract comprises a complex ecosystem with extensive interactions between normal or neoplastic epithelial cells with immune, neuronal, and other cell types, as well as microorganisms and metabolites within the gut lumen. Specifically, the intricate relationship between the GI tract and the central nervous system (CNS), collectively known as the brain-gut axis, plays a pivotal role in the pathogenesis of gastrointestinal disorders and neoplasm. For instance, chronic stress increased the risk of colon cancer via activating the COX-2\u002FPEG2 system and promoted tumor cell dissemination by remodeling lymph vasculature. The bidirectional communications of the brain-gut axis are generally found to be mediated by neurotransmitters, inflammatory cytokines, metabolites, or gut microbiota. Nonetheless, the spotlight has shone primarily on the brain-gut crosstalk mechanisms in experimental cellular or animal models, with less attention paid to the structural and functional alterations on the brain networks at the patient level.\n\nThe evolution of functional neuroimaging modalities and neuroscience technologies has enabled accurate delineation of CNS activities. Specifically, nuclear medicine imaging technology using 2-18F fluoro-2-deoxy-D-glucose (18F-FDG) to adopt whole-body imaging information, is the optimal in vivo method for the investigation of regional human brain metabolism and associations with systemic disorders. We have previously identified the neuronal metabolic-ventricular dyssynchronization axis which might related to major arrhythmic events using myocardial perfusion imaging and the brain 18F-FDG positron emission tomography (PET). Given the potential dual interactions of the brain-gut axis, identification of specific brain regions associated with CRC development and progression might lead to a better understanding of the disease's neurobiological underpinnings and inform the development of targeted therapeutic strategies.\n\nHence, this study was structured to elucidate the role of neuro-metabolism and its potential mediator in regulating CRC tumorigenesis and metastasis. By delving into the neurometabolic-gut axis in CRC, the resulting mechanistic insights might be leveraged to identify diagnostic and prognostic biomarkers and to develop novel therapeutic interventions for CRC patients.",[440,27],"Cancer","2025-04-28",{"date":443,"type":37},"2025-04-30",{"date":445,"type":37},"2024-03-01",{"date":148,"type":20},{"name":448,"class":44},"The First Affiliated Hospital of Zhengzhou University",{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":336,"enrollmentInfo":455,"targetDuration":4,"studyType":21,"phases":457,"briefSummary":459,"conditions":460,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":45},"100587357","phase-4-the-study-on-the-efficacy-of-tdcs-stimulation-of-the-cerebellum-combined-with-xingnaojing-injection-in-patients-with-consciousness-disorders-after-cranial-injury-100587357","NCT06927336","The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury","Inclusion Criteria:\n\n1. aged 18-80 years;\n2. All patients met the diagnostic criteria of DoC;\n3. more than 1 month after the initial head injury;\n4. stable consciousness for at least 2 weeks before admission (no change in CRS-R total score);\n5. no skull defect or large area of skull repair;\n6. The legal representative authorized by the patient approved the experimental protocol and signed the informed consent form.\n\nExclusion Criteria:\n\n1. supratentorial abnormalities on computed tomography (CT) or magnetic resonance imaging (MRI) involving more than one third of the middle cerebral artery territory;\n2. a life expectancy of less than 3 months or a follow-up of less than 3 months;\n3. retention of intracranial metal objects, cranial debridement, or presence of cranial defects and any clinically significant or unstable medical diseases;\n4. EEG recording with significant muscle artifacts and inhibitory bursts;\n5. nonconvulsive status epilepticus; Periodic or burst rhythms evoked by stimulation;\n6. disturbance of consciousness due to surgical injury or tumor.",{"count":456,"type":20},200,[458],"PHASE4","The purpose of this study is to investigate the effect of tDCS stimulation of cerebellum combined with Xingnaojing on patients with disturbance of consciousness after craniocerebral injury, and to clarify the relationship between the following two points: (1) to clarify whether MMN, P300, fNIRS, BAEP, SEP can be used as objective indicators to distinguish VS from MCS. (2) To clarify the changes of consciousness level and brain function in DoC patients with craniocerebral injury treated with tDCS stimulation of cerebellum combined with Xingnaojing.",[461,462,27,463],"tDCS","Cerebellum","Disturbance of Consciousness","2025-04-14",{"date":466,"type":37},"2025-04-15",{"date":468,"type":20},"2025-04-25",{"date":470,"type":20},"2026-12-30",{"name":472,"class":44},"The Second Affiliated Hospital of Kunming Medical University",{"id":474,"slug":475,"hasResults":11,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":21,"phases":482,"briefSummary":483,"conditions":484,"keywords":491,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":45},"100585068","act-for-mental-health-in-neurological-disorders-100585068","NCT06897553","ACT for Mental Health in Neurological Disorders","Acceptance and Commitment Therapy- Based Group Therapy for Mental Health in Neurological Disorders","Inclusion Criteria:\n\n* Value above a cut-off of the DASS-21 subscales (depression \\> 10, anxiety \\> 6, and stress \\> 10)\n* Sufficient cognition and language ability (clinical rating)\n* Sufficient therapy motivation (clinical rating)\n\nExclusion Criteria:\n\n* Behavioral disorders (e.g., high irritability or apathy in clinical rating)\n* Other severe mental disorder (dementia, psychosis, personality disorders, intellectual disability)\n* Simultaneous psychotherapy or neuropsychological therapy",{"count":481,"type":20},44,[23],"The goal of this clinical trial is to examine the efficacy of this manual for mental health in people with mixed neurological disorders, including post-COVID. These conditions are often associated with cognitive impairment, which may hamper the effects of psychoterapy. Executive functioning and especially the ability to abstract thinking may be useful for individuals using Acceptance and Commitment Therapy. Therefore, the main questions research questions are:\n\n* Is this intervention effective in improving mental health?\n* Do executive functions predict the extent of social participation and mental health at the end of therapy? Participants will take part in 8 weekly group therapy sessions of 100 minutes each.",[485,486,487,488,489,27,490],"Neurological Disorders","Mental Health","Executive Function (Cognition)","Depression\u002FAnxiety","Stress","Post-COVID",[492,493,494,263,495,496,497,498,499,490],"Acceptance and Commitment Therapy (ACT)","group therapy","neurological disorders","anxiety","stress","depression","executive functioning","abstraction ability","2025-03-25",{"date":502,"type":37},"2025-03-27",{"date":504,"type":37},"2024-12-01",{"date":506,"type":20},"2026-12-31",{"name":508,"class":44},"Bielefeld University",{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":53,"sex":283,"minAge":54,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":517,"conditions":518,"keywords":521,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":45},"100583479","university-of-central-florida-cerebank-100583479","NCT06876857","University of Central Florida CereBank","Inclusion Criteria:\n\n* Be 18 years or older.\n* Able to provide informed consent. Persons who are unable to provide an informed consent will need a Legally Authorized Representative (LAR) to sign the informed consent.\n\nExclusion Criteria:\n\n* minors (under age 18).\n* prisoners.\n* pregnant women.",{"count":516,"type":20},50000,"Millions of persons are affected by brain diseases. The CereBank will be used to support research studies aimed at improving the diagnosis and treatment of brain diseases. Brain diseases can be inherited; developed due to diseases or aging; or can be due to trauma. The Central Florida does not have a brain biobank to meet the needs of research. Therefore, it is necessary for the University of Central Florida to establish a brain biobank.",[519,27,520],"Biospecimen Donation","Brain Diseases",[522,523,524,525,526,527,528],"donate","biobank","brain","biospecimen","Alzheimer's Disease","Autism","Huntington's Disease",{"date":530,"type":37},"2025-03-14",{"date":532,"type":37},"2025-02-25",{"date":534,"type":20},"2075-02-25",{"name":536,"class":44},"University of Central Florida",{"id":538,"slug":539,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":53,"sex":16,"minAge":545,"maxAge":546,"enrollmentInfo":547,"targetDuration":4,"studyType":21,"phases":548,"briefSummary":549,"conditions":550,"keywords":553,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":45},"100575605","validation-of-a-3d-instrumented-serious-game-to-evaluate-upper-limb-impairments-in-children-with-neuromotor-disorders-100575605","NCT06774456","Validation of a 3D Instrumented Serious Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders","Validation of a 3D Motion Analysis Protocol With an Instrumented Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders","Play2BEAPI","Inclusion Criteria:\n\n* Children with NMD\n\n  * Informed Consent signed by the subject\n  * Aged from 5 to 13 years,\n  * Non-progressive neurological lesions (cerebral palsy, stroke, traumatic brain injury, etc.),\n  * With sufficient grasp ability to perform the 3D protocol tasks (MACS level I to III),\n* TD children\n\n  * Informed Consent signed by the subject\n  * Aged from 5 to 13 years,\n\nExclusion Criteria:\n\n* Children with neuromotor disorders\n\n  * inability to follow the procedures of the investigation because of severe cognitive or visual disturbances,\n  * upper limb (UL) disorders that may affect movement (fractures less than 6 months prior to participation, pain (visual analogic score (VAS) score \\> 0), etc.).\n  * previous UL surgery, and botulinum toxin injections less than three months prior to participation,\n* TD children\n\n  * Inability to follow the procedures of the investigation because of severe visual disturbances,\n  * UL disorders that may affect movement (fractures less than 6 months prior to participation, pain (VAS score \\> 0), etc.).","5 Years","13 Years",{"count":109,"type":20},[23],"The goal of this clinical trial is to validate an instrumented 3D serious game to assess upper limb impairments in children with neuromotor disorders. The main questions are:\n\n* Does an instrumented 3D serious game can provide a set of validated upper limb movement features with good reliability, validity and responsiveness ?\n* Does the instrumented 3D serious game could provide better immersion, adhesion, usability and satisfaction than a \"classic\" 3D protocol, thanks to the developped environment ?\n\nResearchers will compare children with neuromotor disorders and typically developing children to assess discriminant validity of the new assessement.\n\nChildren with neuromotor disorders will have 2 visits to the hospital :\n\n* Visit 1 : children will perform a validated 3D protocol and the instrumented 3D serious game\n* Visit 2 : children will have a clinical examination and will perform the instrumented 3D serious game\n\nTypically developing children will have one visit to the hospital. They will perform the instrumented 3D serious game.",[551,27,552],"Cerebral Palsy","Neurological; Disorder, Nervous System",[554,555,556,557,558,559,560],"Children","upper limb","motion analysis","serious game","neuromotor disorders","bimanual function","electromyography","2025-01-08",{"date":563,"type":37},"2025-01-14",{"date":565,"type":20},"2025-02",{"date":567,"type":20},"2027-01",{"name":569,"class":44},"University Hospital, Geneva",{"id":571,"slug":572,"hasResults":11,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":21,"phases":579,"briefSummary":580,"conditions":581,"keywords":585,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":596},"100571677","protective-effect-of-angong-niuhuang-against-negative-inflammatory-response-and-neurologic-dysfunction-after-cardiovascular-surgery-100571677","NCT06723366","Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery","Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery (PANDA X)","Inclusion Criteria:\n\n* (1) an age \\> 18 years,\n* (2) underwent cardiovascular surgery,\n* (3) diagnosis of acute neurologic dysfunction, including but not limited acute cerebral infarction of the internal carotid artery system,\n* (4) a National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20,\n* (5) a time from symptom onset to randomization within 36 h,\n* (6) provision of informed consent.\n\nExclusion Criteria:\n\n* (1) not suitable for taking ANP after the dialectical process by a traditional Chinese medical doctor,\n* (2) received ANP within 1 month before stroke onset,\n* (3) liver failure,\n* (4) declined to participate in this study.",{"count":578,"type":20},120,[23],"Neurologic Dysfunction is one of the main factors contributing to poor outcomes in cardiac surgery patients, except for heart failure. Atherosclerosis of the aorta, a history of cerebral infarction, and cervical artery disease are common clinical risk factors for cerebral neurological dysfunction after cardiac surgery. Results of preclinical studies suggested that Angong Niuhuang Pills (ANPs), a traditional Chinese patent medicine, including realgar, cinnabaris, Bovis Calculus, artificial Moschus, and powdered buffalo horn extract, decreased infarct volume and cerebral edema, and presented anti- atherosclerosis and cardio-protective effects in clinical and preclinical studies. The PANDA X trial is designed as a pilot study to explore the safety and efficacy of ANP in patients with moderate-to-severe neurologic dysfunction after cardiovascular surgery.",[582,583,584,27],"Cardio-pulmonary Bypass","Cardiovascular Surgery","Cerebral Protection",[586,231],"Inflammatory Response","2024-12-09",{"date":589,"type":37},"2024-12-12",{"date":591,"type":20},"2025-01-01",{"date":593,"type":20},"2025-12-31",{"name":595,"class":44},"Nanjing Medical University",2,{"id":598,"slug":599,"hasResults":11,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":603,"eligibilityCriteria":604,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":336,"enrollmentInfo":605,"targetDuration":4,"studyType":21,"phases":607,"briefSummary":608,"conditions":609,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":619,"locationsCount":596},"100569740","motor-performance-improvement-after-visual-rehabilitation-100569740","NCT06698172","Motor Performance Improvement After Visual Rehabilitation","Analysis of Motor Performance Improvement Following Visual Rehabilitation Treatment in Individuals with Visual Field Defects Due to Acquired Brain Injury","VRvisual","Inclusion Criteria:\n\n* Adult subjects diagnosed with acquired brain injury either from a stroke or trauma.\n* Subjects without cognitive impairment.\n* Subjects without pre-existing musculoskeletal disorders prior to the acquired brain injury.\n* Subjects without hemineglect.\n* Subjects with more than 6 months of progression since the brain injury.\n* Subjects who have an electronic device such as a computer and internet access to perform the exercises at home.\n* Subjects with altitudinal visual field loss, hemianopia, or quadrantanopia with the central field preserved and at least 0.5 visual acuity.\n\nExclusion Criteria:\n\n* Not signing the informed consent.\n* Previous severe mental pathology to eliminate possible confounding factors if their daily activities are already affected.\n* Uncontrolled epilepsy.\n* Subjects with glaucoma or retinal pathologies affecting the visual field.\n* Subjects with previous ocular surgery (cataract or refractive surgery) with less than 6 months of progression.\n* Subjects who are not stable in any associated clinical pathology or otherwise diagnosed.\n* Subjects who have previously undergone visual rehabilitation for the field defect.\n* Not performing the proposed home exercises.",{"count":606,"type":20},30,[23],"Acquired brain injury\" refers to brain damage that impacts neurological processing, making daily activities challenging and often causing vision issues like binocular dysfunction, oculomotor problems, and visual field loss. In Spain, visual rehabilitation is limited, although it is more common in other countries.\n\nThese patients generally need an interdisciplinary approach involving professionals like physiotherapists and optometrists and often face mobility, balance, and spatial perception difficulties. Treatment tools include lenses, prisms, and technologies like virtual reality (VR). The Visionary VR program, presented by Dr. Portela, has shown promising results in visual field recovery by stimulating the affected area.\n\nVisual rehabilitation is based on brain plasticity and involves three key strategies:\n\nPrisms to expand the visual field. Compensatory therapy to improve eye movement. Restitution therapy to restore the visual field.",[610,611,27,612],"Visual Field Loss","Balance","Motor Performance","2024-11-18",{"date":615,"type":37},"2024-11-20",{"date":617,"type":20},"2024-11-29",{"date":593,"type":20},{"name":620,"class":44},"Instituto de Investigación Sanitaria Aragón",{"id":622,"slug":623,"hasResults":11,"nctId":624,"briefTitle":625,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":628,"targetDuration":629,"studyType":57,"phases":4,"briefSummary":630,"conditions":631,"keywords":634,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":45},"100566925","acquired-brain-injury-and-neurorehabilitation-the-influence-of-psychological-characteristics-100566925","NCT06661512","Acquired Brain Injury and Neurorehabilitation: the Influence of Psychological Characteristics","DANEA","Inclusion Criteria:\n\n1. Age over 18 years\n2. Present acquired brain damage (stroke, head trauma, encephalopathy, brain tumor, or anoxia) after less than 6 months of evolution.\n3. Participants must present a cognitive alteration objectified through a neuropsychological examination.\n4. Be correctly oriented in person, space and time (assessed by psychometric tests).\n5. Have a good command of Spanish.\n\n   Exclusion Criteria:\n6. Presenting a neurological or psychiatric history.\n7. Presenting a language disorder or severe visual-perceptive disorder - hemineglect - that prevents participation in the study (does not allow for correct administration of the questionnaire).\n8. A posteriori criterion (once the study has begun): Answering incorrectly to any of the validity items included in the questionnaire. This situation leads to automatic exclusion from studies.\n\nThe initial neuropsychological examination will be used to check whether participants meet inclusion criteria 3 and 4, as well as exclusion criterion 7. This examination includes orientation tests (subtest of the Barcelona Orientation Test), language tests (subtests of the Barcelona Word Repetition Test, Word Naming and Command Comprehension Test) and visual-perception tests (subtests of the Barcelona Superimposed Figures Test). Only those participants who correctly answer all the items will be selected.",{"count":456,"type":20},"4 Months","Acquired brain damage generates motor, cognitive, behavioral and emotional deficits. Neurorehabilitation aims to reduce these deficits and develop compensatory strategies that increase the person's functionality. However, the success of neurorehabilitation process varies and is influenced by the type of injury, the characteristics of the patient or the treatment received. Despite all the studies about patient characteristics, psychological aspects currently continue to be a field to be explored.\n\nThe main objective of the study is to study the psychological characteristics of people with brain damage. Secondary objectives include analyzing its link with other indicators, exploring possible differences depending on the etiology of brain damage, assessing its evolution during neurorehabilitation and exploring its prognostic value.\n\nTo carry out this prospective longitudinal observational study, adult patients with acquired brain damage to less than 6 months of evolution who present an objective cognitive alteration will be selected. Patients with a neurological or psychiatric history will be excluded.\n\nPatients included in the study will be administered computerized questionnaires at the beginning of the neurorehabilitation program. The same questionnaires will be administered again 2 months later. In those hospitalized patients who subsequently continue outpatient treatment, a third administration will be performed (2 months after the second administration).",[27,632,633],"Stroke Patients","TBI-Traumatic Brain Injury",[263,635,636],"neurorehabilitation","psychological characteristics","2024-10-25",{"date":639,"type":37},"2024-10-28",{"date":641,"type":20},"2024-11",{"date":643,"type":20},"2029-11",{"name":645,"class":44},"Institut Guttmann",{"id":647,"slug":648,"hasResults":11,"nctId":649,"briefTitle":650,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":21,"phases":655,"briefSummary":656,"conditions":657,"keywords":662,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":676,"completionDateStruct":677,"leadSponsor":679,"locationsCount":45},"100563802","expanding-access-to-mtbi-treatment-for-veterans-and-service-members-with-co-occurring-substance-use-100563802","NCT06620900","Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use","ExpandAccess","Inclusion Criteria:\n\n* At least 18 years of age\n* US military service member or veteran\n* Diagnosis of mild traumatic brain injury (mTBI) and\u002For repetitive head impact\u002Fblast exposures\n* Participating in the SHARE Military Initiative intensive outpatient program\n\nExclusion Criteria:\n\n* History of brain injury other than mTBI or progressive neurological disorder\n* Active psychosis\n* Not able to provide consent",{"count":654,"type":20},360,[23],"The purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms, goals, and needs.\n\nParticipants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge.",[658,27,659,660,661],"Concussion, Mild Traumatic Brain Injury","Traumatic Brain Injury","Substance Use","Substance Use Disorder (SUD)",[663,664,27,665,666,667,668,669,670,671,672],"Concussion","Mild Traumatic Brain Injuty","Substance use","Substance Use Disorder","Military","Service Members","Veterance","Interdisciplinary","Intensive Outpatient Program","Neurorehabilitation","2024-09-26",{"date":675,"type":37},"2024-10-01",{"date":565,"type":20},{"date":678,"type":20},"2028-08",{"name":680,"class":44},"Shepherd Center, Atlanta GA",{"id":682,"slug":683,"hasResults":11,"nctId":684,"briefTitle":685,"officialTitle":686,"acronym":687,"eligibilityCriteria":688,"healthyVolunteers":11,"sex":16,"minAge":689,"maxAge":4,"enrollmentInfo":690,"targetDuration":4,"studyType":21,"phases":692,"briefSummary":693,"conditions":694,"keywords":697,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":706,"locationsCount":45},"100547579","electrocorticographic-monitoring-of-brain-retraction-injury-embri-100547579","NCT06409806","Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)","Electrocorticography As a Neurophysiological Marker for Intraoperative Monitoring for Brain Retraction: an IDEAL Stage 1 Study","EMBRI","Inclusion Criteria:\n\n* Patients aged 16 or older undergoing intracranial surgery where it is anticipated fixed brain retraction will be used.\n\nExclusion Criteria:\n\n* Patients without capacity to give consent at time of recruitment","16 Years",{"count":691,"type":20},6,[23],"A single centre IDEAL Stage 1 feasibility study using novel electrophysiological recording techniques in adult participants undergoing neurosurgery. This is a first in human study, building upon previous preclinical mice experiments.\n\nParticipants will undergo their planned neurosurgical procedure as normal. In addition to their standard treatment neurophysiological monitoring including an electrocorticography electrode placed on the brain deep to the retractor will be used to monitor for signs of brain retraction injury.",[27,695,696],"Neurosurgery","Brain Ischemia",[698],"Brain retraction","2024-09-17",{"date":701,"type":37},"2024-09-19",{"date":703,"type":37},"2022-08-01",{"date":705,"type":20},"2026-03-01",{"name":707,"class":44},"University College, London",{"id":709,"slug":710,"hasResults":11,"nctId":711,"briefTitle":712,"officialTitle":712,"acronym":713,"eligibilityCriteria":714,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":715,"targetDuration":4,"studyType":21,"phases":717,"briefSummary":718,"conditions":719,"keywords":720,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":723,"lastUpdatePostDateStruct":724,"startDateStruct":726,"completionDateStruct":728,"leadSponsor":730,"locationsCount":45},"100500394","evaluation-of-the-impact-of-the-avancer-program-provided-by-the-arrpac-day-center-100500394","NCT05795686","Evaluation of the Impact of the AVanCer Program Provided by the ARRPAC Day Center","Eval-ARRPAC","Inclusion Criteria:\n\nFor patients :\n\n* Male or female of legal age\n* Patient who has been selected to start the AVanCer program at the ARRPAC center\n* Patient who has agreed to participate in the PATIENT assessment component and has signed the consent form\n* Patient able to speak and understand French both orally and in writing\n\nFor caregivers :\n\n* Male or female of legal age\n* Person who has agreed to participate in the CAREGIVING assessment component and has signed the consent form\n* Person able to speak and understand French both orally and in writing\n\nPopulation of the qualitative study :\n\n* Voluntary patients and caregivers who participated in the quantitative part (follow-up by questionnaires)\n* Partner professionals: a sample of 10 representatives of ARRPAC partners who referred people for support during the first 12 months, from the following structures: public Medicine, Surgery, Obstetric health institution, private Medicine, Surgery, Obstetric health institution, public Follow-up and Rehabilitation Care institution, private Follow-up and Rehabilitation Care institution, medico-social institution, town professionals and user associations.\n* ARRPAC professionals: the 14 ARRPAC professionals involved in the day care centre will be interviewed in a semi-structured manner\n\nExclusion Criteria:\n\n* Pregnant women, parturient or breastfeeding mothers\\*\n* Persons deprived of their liberty by a judicial or administrative decision\n* Persons under psychiatric care\n* Persons admitted to a health or social establishment for purposes other than research\n* Persons of full age subject to a legal protection measure (guardian, curators)\n* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme",{"count":716,"type":20},162,[23],"In France, more than 150,000 strokes occur each year. Stroke is a major risk factor for dependency, representing the leading cause of acquired non-traumatic disability in adults. Head injuries, which are also very frequent, can leave similar neuropsychiatric sequelae.\n\nThese events are brutal and their physical, psychological, emotional, social and financial consequences disrupt the lives of patients and their families. Thanks to improved access to thrombolysis and thrombectomy for the management of acute stroke, the prognosis has been profoundly improved. Nevertheless, the increase in post-stroke survival and the evolution of the type of after-effects require the development of support systems dedicated to these post-stroke patients. The same issues are raised for people who have suffered a head injury with similar consequences that require specialised care.\n\nCurrently, health care is well structured for the acute phase and there is an improvement in the provision of care in specialised rehabilitation services, but the dedicated medico-social provision for people returning home remains insufficient despite the significant needs. The ARRPAC association (Accompaniment, Rehabilitation, Respite after Stroke and Cerebral Palsy) is setting up a new comprehensive medico-social support programme in Lyon (AVanCer programme, opening in June 2022) to improve the autonomy and adaptation capacities of patients and to relieve the social and psycho-affective burden of carers. This experimental day centre, which complements functional rehabilitation and recurrence prevention care, offers adults with brain injury sequelae and their carers therapeutic education programmes, adapted physical activity, social and cognitive remediation and therapeutic workshops, as well as a place for patients and their carers to exchange information and listen. To achieve its ambition, ARRPAC and the AVanCer programme must be integrated into the existing support offer, create partnerships with care structures and evaluate its added value to ensure its sustainability. In case of efficiency and demonstrated benefits for patients, carers and the health system, such a structure could be deployed in other territories.\n\nThis study evaluates the implementation of the AVanCer programme in terms of its effect on the target audience, participants' experience and implementation according to the REAIM evaluative framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance).",[341,27,31],[341,721,31,722,166],"Brain injury","Autonomy","2024-06-24",{"date":725,"type":37},"2024-06-26",{"date":727,"type":37},"2023-06-20",{"date":729,"type":20},"2026-04-20",{"name":731,"class":44},"Hospices Civils de Lyon"]