[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tbi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tbi":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,84,109,132,160,184,209,231,261,287],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100553034","cerebral-autoregulation-brain-perfusion-and-neurocognitive-outcomes-after-traumatic-brain-injury-100553034",false,"NCT06480838","Cerebral Autoregulation, Brain Perfusion, and Neurocognitive Outcomes After Traumatic Brain Injury","CAPCOG-TBI","Inclusion Criteria:\n\n* Documented\u002FVerified TBI (ACRM Criteria) (eg, motor vehicle (MV) occupant, MV pedestrian\u002Fcyclist, fall, other non-intentional, violence\u002Fassault)\n* A documented moderate to severe TBI defined as: Glasgow Coma Scale (GCS) \\\u003C 13, or loss of consciousness (LOC) \\> 30 minutes, or posttraumatic amnesia (PTA) \\> 24 hours or intracranial neuroimaging abnormalities\n* Between the age 18 - 80 year-old\n* ≤ 1 week postinjury\n* Acute brain CT for clinical care\n* Admitted to the hospital for TBI\n* Visual acuity\u002Fhearing adequate for testing\n* Fluent in English or Spanish\n* Patient or LAR ability to provide informed consent\n\nExclusion Criteria:\n\n* Age greater or less than the range 18-80 years\n* Significant polytrauma that would interfere with follow-up and outcome assessment\n* Major debilitating baseline mental health disorders (e.g., schizophrenia, bipolar disorder, severe depression with active suicidal thoughts at the time of evaluation) that would interfere with follow-up and the validity of outcome assessment.\n* Major debilitating neurological disease (e.g., stroke, CVA, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment.\n* Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment (e.g., active substance abuse, alcoholism, HIV\u002FAIDs, end-stage cancers, learning disabilities, developmental disorders)\n* Patients on psychiatric hold\n* Prisoners or patients in custody\n* Pregnancy in female subjects\n* Low likelihood of follow-up (e.g., participants or family indicating low interest, residence in another state or country, homeless or lack of reliable contacts)\n* Current participant in an interventional trial (e.g., drug, device, behavioral)\n* Penetrating TBI\n* Spinal cord injury with ASIA score of C or worse\n* Contraindications to MRI","ALL","18 Years","80 Years",{"count":20,"type":21},130,"ESTIMATED","OBSERVATIONAL","Cognitive impairment after moderate to severe traumatic brain injury (msTBI) not only significantly affects the quality of life in individuals with msTBI, but also increases the possibility of late-life dementia. The goal of this study is to determine whether acute (\\\u003C 1 week) cerebrovascular injury and its recovery within the first year postinjury measured by cerebral autoregulation and brain perfusion are associated with cognitive outcome at 12 months after msTBI. The results from this study will improve our understanding of cerebrovascular contributions to cognitive decline related to TBI and provide critical data to inform the development of strategies based on vascular mechanisms to improve cognition and prevent neurodegeneration after msTBI.",[25,26,27,28,29],"Traumatic Brain Injury With Loss of Consciousness","Brain Injury Traumatic Severe","Brain Injury Traumatic Moderate","TBI (Traumatic Brain Injury)","TBI","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2023-09-01",{"date":38,"type":21},"2029-05-31",{"name":40,"class":41},"University of Texas Southwestern Medical Center","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100615129","insight-insomnia-nightmares-and-sympathetic-hyperactivity-intervention-100615129","NCT07288593","INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention","Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention in the warfiGHTer (INSIGHT)","INSIGHT","Inclusion Criteria:\n\n* Defense Enrollment Eligibility Reporting System (DEERS) Eligible\n* Current or former military service member\n* Able to read and understand English language without the use of an interpreter\n* Habitual bedtime between 9:00 PM and 1:00 AM\n* Aged 18-62 (inclusive)\n* Able to commit to study procedures\n\nExclusion Criteria:\n\n* Use of alpha or beta-receptor active medications or prescribed sleep aids in the last 3 months\n* Started use of SNRIs or SSRIs in the last 3 months\n* Pregnant\n* Receiving ongoing and extensive treatment for a new or acute psychiatric disorder within 90 days, other than routine follow-up and care\n* Starting concurrent evidence based psychiatric treatment within the past three months\n* Diagnosis of a serious medical condition (i.e., late-stage cancer or heart disease)\n* Routine night shift work in the past 3 months\n* Unstable neurological disease\u002Fautonomic disorders\u002F heart conditions\u002Fpsych\u002F sleep or other unstable disorder as determined by the Principal Investigator\u002FAssociate\n* Investigators determined by clinical interview by Mini international neuropsychiatric interview and medical health questionnaire\n* Excessive alcohol use as determined by the AUDIT-C (AUDIT-C \\> 3)\n* Started using any other medication (prescribed or over-the-counter) for the purpose of improving sleep in the last 90 days (e.g., barbiturates, benzodiazepines, melatonin, natural supplements and herbs, antidepressants, antihistamines, etc.)\n* Receiving treatment for substance use disorder within 90 days from the start of the study\n* Evidence of moderate or severe Obstructive Sleep Apnea (OSA): Determined by the STOP-BANG questionnaire: STOP-BANG greater than 5 Determined by EMR PSG records: moderate or severe OSA \\[apnea-hypopnea index (AHI)≥15\\]\n* Clinically significant suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)\n* Currently participating in other research studies for improving sleep\n* Currently participating in other research studies for improving PTSD\n* Currently in therapy for the primary purpose of improving sleep (e.g., CBT-I)\n* Currently undergoing other treatment to improve sleep (e.g., acupuncture)\n* History or diagnosis of any of the following sleep disorders: narcolepsy, shift-work disorder or circadian rhythm disorders\n* Prone to problems with venipuncture including fainting, hematoma, and infection\n* Moderate and high nicotine dependence based on the Fagerstrom Test for Nicotine Dependence (\\> 4 on the Fagerstrom Test for Nicotine Dependence) High caffeine dependence based on the Caffeine Dependence Questionnaire (\\> 30 on the Caffeine Dependence Questionnaire)\n* Currently experiencing a neurological disorder (e.g., stroke, Parkinson's, MS, etc.)\n* Exclusion for optional MRI visit:\n\nMetal in body that is ferromagnetic \u002F incompatible with MRI or other safety issues and indicated by screen Previous adverse reactions to sleep deprivation Illicit drug use as determined by participant self-report Alcohol in system at time of MRI overnight as determined participant self report Nicotine use in the last 3 months\n\nFor poor sleep group:\n\nTBI History of epilepsy or suspected seizure disorder.",true,"62 Years",{"count":54,"type":21},180,"INTERVENTIONAL",[57],"NA","The INSIGHT study is a multi-site clinical research program designed to examine how insomnia and symptoms of sympathetic hyperactivity impair sleep, cognition, and physiological restoration in warfighters, and to evaluate whether a wearable therapeutic device can improve these outcomes. Warfighters with a history of traumatic brain injury, post-traumatic stress disorder, or chronic operational stress commonly report disrupted sleep accompanied by manifestations of nocturnal sympathetic activation such as diaphoresis, palpitations, hyperarousal, and nightmares. These symptoms erode sleep quality, reduce cognitive performance, and undermine psychological resilience and operational readiness. Insomnia is two to three times more common in military populations than in civilians, and both TBI and PTSD independently elevate the risk for dysregulated autonomic tone. Excessive sympathetic activity during REM sleep disrupts the normally quiescent locus coeruleus state required for adaptive emotional processing and may contribute to the genesis of nightmares. Excessive sympathetic tone may also interfere with deep NREM-dependent glymphatic clearance, a recently discovered mechanism that supports cognitive restoration and metabolic waste removal. Yet, no study has comprehensively linked these physiological processes in warfighters or evaluated whether wearable-derived autonomic measures can meaningfully stratify insomnia phenotypes. The INSIGHT protocol addresses this gap through a two-phase design integrating multimodal biomarker collection, wearable technology validation, advanced imaging, and a randomized controlled intervention. Phase 1 enrolls 250 participants (50 healthy controls and 200 poor sleepers with or without PTSD and TBI) who undergo structured screening, cognitive testing, and detailed baseline assessments before completing a 2-week at-home data collection period. During this period, participants wear a suite of devices, including EEG headbands, ECG patches, PPG-based sensors, accelerometry rings, blood pressure devices, temperature sensors, and smartwatches, to capture autonomic activity, sleep architecture, cardiovascular and respiratory variability, movement, sudomotor activity, and circadian body temperature patterns. Ecological momentary assessments administered three times daily track fluctuations in sleep quality, mood, PTSD symptoms, and daytime functioning, while urine samples collected on the final three days allow for biochemical analysis of hormonal and sympathetic biomarkers. After the at-home period, all participants complete an overnight in-lab polysomnogram combined with fNIRS to measure sleep stages, autonomic dynamics, cerebral hemodynamics, and glymphatic signatures. A subset of participants also completes an optional overnight MRI with simultaneous EEG following controlled sleep deprivation, enabling state-of-the-art imaging of human glymphatic activity using the MAGNUS MRI platform. This optional visit provides unprecedented insight into how TBI, PTSD, and insomnia alter the physiology of sleep-dependent brain fluid dynamics. In Phase 2, all poor sleepers enter a double-blind, sham-controlled, 30-day randomized trial testing the therapeutic potential of the NightWare smartwatch. NightWare detects sympathetic surges during sleep through heart rate elevations and movement patterns and delivers brief haptic vibrations aimed at interrupting escalating autonomic arousal. Although originally cleared for nightmare treatment, its mechanism is well suited for SNH-related insomnia more broadly. Participants use the device daily while continuing EMA surveys, wearable monitoring, and cognitive assessments, generating rich physiological and behavioral data throughout the intervention. The primary goal is to determine whether reducing nocturnal sympathetic spikes leads to measurable improvements in sleep quality, autonomic stability, daytime functioning, and symptom burden. In parallel, Phase 2 data enable development of the Multi-Organ Autonomic Index of Sleep, an integrated biomarker model that combines neurological, cardiovascular, respiratory, and dermal signals to predict treatment response and classify insomnia subtypes.\n\nThe INSIGHT study will produce the most comprehensive dataset to date linking autonomic physiology, glymphatic function, sleep architecture, wearable-derived biomarkers, cognition, and clinical outcomes in warfighters. By identifying physiological signatures of sympathetic hyperarousal and determining whether a non-pharmacological wearable intervention can meaningfully improve sleep, INSIGHT directly supports Department of Defense priorities to enhance readiness, resilience, and long-term neurological health in service members. Wearable tools capable of monitoring and improving sleep outside the laboratory have the potential to transform both clinical care and operational performance, offering scalable and accessible approaches to restoring sleep and optimizing recovery.",[60,61,62,29,63,64],"Nightmare","Insomnia","PTSD","Sleep Disorder (Disorder)","REM Behavior Disorder",[66,67,68,69,70,61,62,71],"Nightmares","Wearables","Intervention","Sleep quality","Hyperarousal","Healthy Participants","NOT_YET_RECRUITING","2026-04-27",{"date":75,"type":34},"2026-04-28",{"date":77,"type":21},"2026-06-01",{"date":79,"type":21},"2027-12",{"name":81,"class":82},"Uniformed Services University of the Health Sciences","FED",2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":51,"sex":16,"minAge":91,"maxAge":17,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100531096","individual-cerebral-hemodynamic-oxygenation-relationships-ichor-1-100531096","NCT06195345","Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)","ICHOR 1","Inclusion Criteria:\n\n* Individuals who are able to tolerate an MRI.\n* Are patients scheduled for a clinically indicated MRI.\n* Between birth and up to 18 years.\n\nExclusion Criteria:\n\n* Presence of an MRI-incompatible device or implant (e.g. pacemakers, stents)\n* Unable to tolerate the enclosed spaces and loud noises for the duration of time in scanner required to obtain an MRI.\n* Preterm infants less than 25 weeks\n* Any patient who is clinically too unstable to extend their MRI by up-to 7.5 minutes.","1 Minute",{"count":93,"type":21},1000,"This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.",[96,28,29,97,98],"HIE","Hemodynamic Instability","Hypoxic-Ischemic Encephalopathy","2026-04-24",{"date":101,"type":34},"2026-04-29",{"date":103,"type":34},"2018-11-01",{"date":105,"type":21},"2035-11-01",{"name":107,"class":41},"Children's Hospital Los Angeles",1,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":55,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":108},"100630119","comparing-approaches-to-helping-people-with-chronic-traumatic-brain-injury-manage-their-health-care-100630119","NCT07483528","Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care","2BeHealthy","Inclusion Criteria:\n\n* community dwelling adult (\\>18 years at enrollment)\n* ≥1-year post-TBI of any severity based on The Ohio State University-TBI Identification Method\n* followed by a brain injury physician for TBI care who refers them to the study\n* must have sufficient comprehension, communication, sensorimotor function, and English proficiency (due to outcome measures not being validated in languages other than English)\n* must provide informed consent and have webcam and Internet access for assessments and approach\n\nAdditionally, meet 1 or more of the following criteria:\n\n* 2 or more current chronic conditions (including chronic TBI)\n* 5 or more medications\n* 3 or more emergency department visits within the past 12 months\n* 1 or more hospital admissions within the past 12 months\n* Under care of 2 or more specialists (non-primary care), including physicians, midlevel providers, therapists, mental health professionals) with visits with these providers in the past 12 months\n\nExclusion Criteria:\n\n* non-community dwelling",{"count":117,"type":21},142,[57],"The goal of this double-masked, randomized control trial is to learn about the potential benefits of two different strategies at helping people with traumatic brain injury who see a brain injury physician be more engaged in their healthcare and feel more confident in managing their health.\n\nThe main questions it aims to answer are:\n\n* When comparing the two strategies, which will result in high participant-reported health empowerment assessed approximately 7 - 21 days of completing the approach?\n* When comparing the two strategies, which will result in high participant-reported health engagement assessed approximately 7 - 21 days of completing the approach?\n\nParticipants will:\n\n* complete baseline assessments about their health, daily activities, and their attitudes about healthcare and their treatment. These will be done over the phone and\u002For online survey.\n* have one virtual session with a health professional to discuss their health and wellness.\n* 7-21 days after the session with a health professional, participants will complete an online survey about their attitudes about healthcare and their treatment.\n* Some participants may be invited to complete an additional interview about their study participation around 3 months after their session with the health professional.",[121,122,29],"Traumatic Brain Injury","Traumatic Brain Injury (TBI) Patients","2026-03-16",{"date":125,"type":34},"2026-03-19",{"date":127,"type":21},"2026-06",{"date":129,"type":21},"2028-08",{"name":131,"class":41},"Indiana University",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":55,"phases":142,"briefSummary":143,"conditions":144,"keywords":149,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":108},"100515759","a-mixed-methods-pilot-trial-of-the-step-home-workshop-to-improve-reintegration-and-reduce-suicide-risk-for-recently-transitioned-veterans-100515759","NCT05995678","A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans","SH-SP","Inclusion Criteria:\n\n* Recently transitioned Veterans within three years of separation from military service\n* Self-reported functional impairment or reintegration difficulties as measured by the Military-to-Civilian Questionnaire (any item score \\> 1 indicating \"some difficulty\"; M2CQ; \\[71\\])\n* Sufficient English fluency\n* Agree to participate (informed consent\u002FHIPAA)\n\nExclusion Criteria:\n\n* Active psychosis\n* Imminent or acute high suicide risk requiring immediate crisis intervention (low-moderate non-imminent risk for suicide is allowed)\n* Current moderate or severe substance use disorder\n* Neurological diagnosis excluding TBI\n\n  * Participants with mild substance use disorder will be allowed\n  * Substance use is a common behavior that may contribute to reintegration difficulties and suicide risk","65 Years",{"count":141,"type":21},120,[57],"Risk of Veteran suicide is elevated during the first year of transition from military service to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA healthcare. Suicide prevention and connection to care are therefore critical for recently transitioning Veterans. Transitioning Veterans require services to provide them with suicide prevention education, skills to manage their transition effectively, and support in their access to VA healthcare. Convenient, accessible, palatable, patient-centered care options that are cost-effective, easy to implement nationwide, and target domains known to mitigate suicide risk are needed during this critical transition period. This proposal would bridge this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing, skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education, skills to improve transition, support to access VA care, and a platform to decrease social isolation early in their military to civilian transition, thereby reducing suicide risk downstream.",[29,145,146,62,147,148],"Suicide Prevention","Veterans","Transdiagnostic","Anger",[146,29,147,68,145,62,150],"Reintegration","2026-03-04",{"date":153,"type":34},"2026-03-06",{"date":155,"type":34},"2024-03-01",{"date":157,"type":21},"2027-05-31",{"name":159,"class":82},"VA Office of Research and Development",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":167,"targetDuration":4,"studyType":55,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":108},"100623460","assessment-of-safety-and-effectiveness-of-spatial-stimelmd-ssmd-in-subjects-with-upper-limb-neuromotor-impairments-100623460","NCT07396922","Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments","A Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation","Inclusion Criteria:\n\n1. Adult men and women aged 18-80 years.\n2. Clinically confirmed diagnosis of stroke, TBI, spinal cord injury, or peripheral nerve injury within the past 24 months.\n3. Presence of moderate to severe neuromotor impairment in at least one limb, as evidenced by medical evaluation and a score \\\u003C35 on the Fugl-Meyer Upper Extremity motor subscale (FMA-UE).\n4. Capacity and willingness to provide informed consent, indicating understanding of the study purpose, procedures, and potential risks and benefits.\n5. Subject is able to adhere to the study schedule and cognitively capable to perform the treatment.\n6. Stable medical condition without ongoing acute complications that could interfere with participation.\n\nExclusion Criteria:\n\n1. Presence of contraindications to electrical stimulation (ES), including implanted electronic medical devices (e.g., Cardiac demand pacemakers, Implantable pacemakers, Implantable cardioverter defibrillators, Implantable neurostimulators, Body-worn devices such as insulin pumps) or conditions that may be exacerbated by electrical stimulation (e.g., uncontrolled epilepsy).\n2. Individuals with medical conditions, which are prone to seizures or motion sensitivity, at the investigator's discretion.\n3. Individuals with light sensitivity, as the AR component may involve visual stimuli that could cause discomfort or adverse reactions in these patients.\n4. Individuals with acute physical conditions or injuries that could interfere with the proper placement of the electrodes or safe use of the device.\n5. Presence of spinal shock or unresolved acute spinal cord dysfunction, characterized by complete loss of reflexes, flaccid paralysis, or autonomic instability.\n6. Current participation in other clinical trials that could confound the study results.\n7. Severe cognitive impairment that precludes the ability to provide informed consent or reliably adhere to the study protocol, as determined by cognitive screening and clinical judgment.\n8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.",{"count":141,"type":21},[57],"This study will evaluate the safety and performance of the Spatial StimeMD (SSMD) medical device in people with multiple sclerosis (MS). The SSMD device is intended to support patients through a non-invasive stimulation program. The study will assess changes in MS-related symptoms and physical function using clinical assessments and patient-reported outcomes.",[171,29,172,173],"Stroke","Spinal Cord Injury","Peripheral Nerve Damage","2026-02-08",{"date":176,"type":34},"2026-02-11",{"date":178,"type":21},"2026-12-30",{"date":180,"type":21},"2027-01-30",{"name":182,"class":183},"Motion Informatics LTD","INDUSTRY",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":55,"phases":193,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":108},"100370874","strengthening-neuro-cognitive-skills-for-success-in-school-work-and-beyond-100370874","NCT04109027","Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond","Inclusion Criteria:\n\n* Post 9\u002F11 Veterans\n* age 21-60; with history of mild-moderate TBI (including reported mechanism of head injury and alteration of consciousness);\n* in the chronic, stable phase of recovery (\\>6 months from injury); with at least 1 self-reported cognitive symptom, --including difficulties with working memory; and interested in goal-setting and intensive training.\n\nExclusion Criteria:\n\n* Severely apathetic\u002Fabulic, aphasic, or other reasons for being unable or unwilling to participate in training;\n* severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains);\n* schizophrenia;\n* bipolar disorder;\n* history of other neurological disorders;\n* current medical illnesses that may alter mental status or disrupt participation in the study;\n* active psychotropic medication changes;\n* symptom magnification or malingering.","21 Years","60 Years",{"count":141,"type":21},[57],"For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain injury (TBI) often struggle with these very abilities, and a number of barriers can make it difficult for them to access the help Veterans need. Tele-rehabilitation has the potential to overcome some of these barriers and increase access to care, enabling providers to better reach Veterans 'where they are' in their communities. This project will assess two different approaches to brain injury rehabilitation that seek to help Veterans build personal strengths to better accomplish their goals. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps to best support Veterans' learning in community settings outside the VA.",[29,196],"Cognitive Dysfunction",[198,199,200],"attention","working memory","executive functioning","2025-11-13",{"date":203,"type":34},"2025-11-17",{"date":205,"type":34},"2024-06-10",{"date":207,"type":21},"2026-05-25",{"name":159,"class":82},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":55,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":229,"locationsCount":108},"100561010","neurobalance-training-to-improve-postural-control-in-individuals-with-traumatic-brain-injury-100561010","NCT06584591","NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury","Neuromodulation-Enhanced Use of RObotic Balance Training to Improve Postural Control in Individuals With Traumatic Brain Injury","Inclusion Criteria:\n\n1. Aged between 18-75 years\n2. Diagnosed with a non-penetrating TBI at least six months before the screening.\n3. Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.\n4. Ability to stand upright with or without support for at least 20 seconds\n5. Ability to walk with or without a walking aid for at least ten meters\n6. Not planning to change medication in the next four months\n7. Minimum Cognitive Ability to understand the verbal instructions and comply with the study procedures, as determined by the University of California, San Diego, Brief Assessment of Capacity to Consent Instrument (UBACC).\n\nExclusion Criteria:\n\n1. Currently undergoing any regular physical therapy program or research studies focusing on balance functions.\n2. Having a stroke or a penetrating TBI.\n3. Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before TBI, or have any persistent pain or difficulty maintaining blood pressure while upright.\n4. Have a scalp or skin condition (e.g., psoriasis or eczema) on the scalp near the stimulation site.\n5. Severe visual impairment (e.g., spatial neglect) or hearing problems may affect study compliance.\n6. Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia, etc.)\n7. Not being pregnant or thinking of becoming pregnant during the study period.\n8. Diagnosed with alcohol or substance abuse in the last three years.\n9. Contraindications to TMS, including the presence of metallic implants in the head and history of seizures or medication-resistant epilepsy.","75 Years",{"count":218,"type":21},45,[57],"Our proposed study, \\"NEUROBALANCE,\\" aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). The study will recruit 45 participants who have had a TBI for over six months and experience persistent balance deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.\n\nThe study will involve 12 training sessions over four weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.\n\nThis research is particularly relevant to military service members, as TBI and balance impairments are common among this population. The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.",[121,29,222,223],"Diffuse Axonal Brain Injury","Brain Injuries, Traumatic","2025-08-01",{"date":226,"type":34},"2025-08-06",{"date":224,"type":34},{"date":79,"type":21},{"name":230,"class":41},"Kessler Foundation",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":238,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":55,"phases":241,"briefSummary":243,"conditions":244,"keywords":248,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":4},"100575229","phase-2-reduced-dose-conditioning-regimen-containing-tbi-in-hsct-treating-elderly-patients-with-aplastic-anemia-100575229","NCT06769568","Reduced-dose Conditioning Regimen Containing TBI in HSCT Treating Elderly Patients With Aplastic Anemia","The Safety and Efficacy of Reduced-dose Conditioning Regimen Containing TBI in Hematopoietic Stem Cell Transplantation Treating Elderly Patients With Aplastic Anemia","Inclusion Criteria:\n\n* ( 1 ) Diagnosis of aplastic anemia, including very severe aplastic anemia, severe aplastic anemia, chronic aplastic anemia and hepatitis-associated aplastic anemia.\n\n( 2 ) Age older than or equal to 50 years old. ( 3 ) Informed consent can be signed by themselves. ( 4 ) HIV negative, HBV, HCV negative. ( 5 ) Informed consent must be signed before the start of the study procedure. Informed consent must be signed by the patient or immediate family members who are 18 years old or older. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.\n\nExclusion Criteria:\n\n* ( 1 ) Patients who underwent more than one time of transplantation before enrollment ; ( 2 ) Uncontrolled infection, mechanical ventilation or hemodynamic instability at the time of enrollment ; ( 3 ) Diagnosis of clinically significant severe liver dysfunction ( defined as Child-Pugh C grade ) within 5 days before enrollment ; or within 5 days before enrollment, AST or ALT was 5 times higher than the upper limit of normal, or serum total bilirubin was 2 times higher than the upper limit of normal ; ( 4 ) End-stage renal insufficiency was diagnosed within 5 days before enrollment, and creatinine clearance rate was less than 10ML \u002F min.\n\n( 5 ) Simultaneous diagnosis of moderate hepatic insufficiency and moderate renal insufficiency ( moderate hepatic insufficiency was defined as Child-Pugh B grade ; moderate renal insufficiency was defined as creatinine clearance rate less than 50ML \u002F min ).\n\n( 6 ) In addition to localized basal cell or squamous cell skin cancer or treatment conditions ( such as lymphoma ), there are active solid tumor malignant tumors.\n\n( 7 ) There was active HIV replication before enrollment. HCV antibody positive, HCV-RNA positive, or HBsAg positive could be detected within 90 days before enrollment. The serological response to HIV or active hepatitis C virus is known to be positive.\n\n( 8 ) Having a mental illness or other condition that does not cooperate with the requirements of research, treatment and monitoring.\n\n( 9 ) unable or unwilling to sign the consent form. ( 10 ) Patients with other special conditions who were assessed as unqualified by the researchers.","50 Years",{"count":240,"type":21},20,[242],"PHASE2","The TBI-containing reduced-dose conditioning regimen was used to treat elderly patients with aplastic anemia who received hematopoietic stem cell transplantation. The overall survival rate, GVHD-free survival rate, all-cause mortality,et al were studied. The modified conditioning regimen included TBI 2Gy, -7d, busulfan 3.2mg \u002F kg-6d ; fludarabine 30mg \u002F m2 \u002F d-5 \\~ -1d ; cyclophosphamide 25-30mg \u002F kg \u002F d-5 \\~ -2d ; ATG ( rabbit ) 2 mg \u002F kg \u002F d-5 \\~ -1d.",[245,246,29,247],"Aplastic Anaemia","HSCT","Old Age",[249,246,250,251],"aplastic anemia","old age","conditioning regimen","2025-01-07",{"date":254,"type":34},"2025-01-10",{"date":256,"type":21},"2025-01-31",{"date":258,"type":21},"2028-09-30",{"name":260,"class":41},"Institute of Hematology & Blood Diseases Hospital, China",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":51,"sex":16,"minAge":238,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":108},"100371332","longitudinal-cognitive-assessment-by-boca-100371332","NCT04114994","Longitudinal Cognitive Assessment by BoCA","BoCA","Inclusion Criteria:\n\nage 50 or older\n\nExclusion Criteria:\n\nyounger than 50 years",{"count":269,"type":21},10000,"The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.",[272,273,274,275,276,277,29],"Alzheimer Disease","Mild Cognitive Impairment","Vascular Dementia","Frontotemporal Dementia","Parkinson Disease","Multiple Sclerosis","2024-07-31",{"date":280,"type":34},"2024-08-01",{"date":282,"type":34},"2019-10-01",{"date":284,"type":21},"2029-10-01",{"name":286,"class":183},"Alzheimer's Light LLC",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":108},"100538274","understanding-patient-engagement-trends-in-tbi-clinical-research-100538274","NCT06288698","Understanding Patient Engagement Trends in TBI Clinical Research","Analyzing Enrolment and Engagement Trends in Individuals Confronting TBI: Insights From TBI Clinical Trials","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Participant must be 18 years of age or older\n* Confirmed diagnosis of TBI\n\nExclusion Criteria:\n\n* Enrolled in another research study\n* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study\n* Inability to provide written informed consent",{"count":295,"type":21},500,"Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.\n\nThe main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.",[29],[29],"2024-02-23",{"date":155,"type":34},{"date":302,"type":21},"2025-03",{"date":304,"type":21},"2027-03",{"name":306,"class":183},"Power Life Sciences Inc."]