[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-brain-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-brain-injury":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,176,0,25,[9,56,79,103,128,155,208,233,261,287,310,334,358,389,428,458,479,501,513,535,559,582,608,632,652],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100053319","cbt-i-vs-mbti-for-traumatic-brain-injury-tbi-related-insomnia-and-post-traumatic-stress-symptoms-100053319",false,"NCT05663034","CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms","CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms","Inclusion Criteria:\n\n1. Current or former member of the uniform services\n2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;\n3. Time duration since traumatic brain injury (TBI) injury \\>90 days\n4. Insomnia symptom duration \\>90 days\n5. Endorse insomnia symptoms (Insomnia Severity Index \\[ISI\\] score \\> 10)\n6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \\> -2)\n7. \\>18 years of age\n8. Access to and ability and to use computer.\n\nExclusion Criteria:\n\n1. History of neurological diseases other than TBI and not attributable to TBI\n2. Sleep apnea \\[apnea hypopnea index (AHI) \\>15; individuals with mild apnea (AHI \\> 5 and \\\u003C15) will be informed, but allowed to participate\\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea\u002Fhypopnea cutoff while using CPAP, are adherent to using the device (\\> 4 hours\u002Fnight 21\u002F30 consecutive days) and agree to continue using the device during study participation.\n3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.","ALL","18 Years",{"count":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).",[27,28,29,30,31,32,33,34,35,36],"Traumatic Brain Injury","Insomnia","Depression","Post-traumatic Stress","Sleep","Memory Impairment","Cognitive Behavioral Therapy","Concussion, Brain","Head Injury","Brain Injury Traumatic Mild",[27,28,38,29,39,35,40,41,42],"Posttraumatic Stress Symptoms","Concussion","Brain Injury","Cognitive Behavioral Therapy for Insomnia","Mindfulness-based Treatment for Insomnia","RECRUITING","2026-07-10",{"date":46,"type":47},"2026-07-13","ACTUAL",{"date":49,"type":47},"2024-05-10",{"date":51,"type":21},"2027-06",{"name":53,"class":54},"Johns Hopkins University","OTHER",5,{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100627938","a-study-to-develop-a-blood-based-test-for-aiding-the-diagnosisprognosis-of-traumatic-brain-injury-in-adults-and-for-monitoring-the-development-of-secondary-events-in-patients-diagnosed-with-traumatic-brain-injury-100627938","NCT07455136","A Study to Develop a Blood-based Test for Aiding the Diagnosis\u002FPrognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury","A Multicenter Prospective Study to Develop a Blood-based Biomarker Test for Aiding the Diagnosis\u002FPrognosis of Traumatic Brain Injury in Adult Subjects (CLIN12.1) and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury (CLIN12.2)","Inclusion Criteria:\n\n* Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration\u002Fdeceleration)\n* Acute brain CT completed for standard of care\n\nFurther Inclusion Criteria (specific for CLIN12.2):\n\n* Admitted to the hospital with radiographic evidence of acute TBI\n* Admitted to the intensive care unit at risk for decline related to TBI\n\nExclusion Criteria:\n\n* Prior neurosurgical intervention within the last 6 months\n* Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments\n* Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments\n* Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder)\n* History of melanoma\n* Primary diagnosis of ischemic or hemorrhagic stroke\n* Any spinal Cord Injury (American Spinal Injury Association \\[ASIA\\] score of A-D)\n* Received chemotherapy or radiation currently or within the last year\n* Patients on psychiatric hold (e.g., 5150, 5250)\n* Current incarceration or in custody\n* Known inability to undergo an MRI\n* Currently receiving any interventional treatments as a part of an investigational study\u002Ftrial (drug, device, behavioral, treatment) at the time of enrollment and\u002For during the course of this study\n* Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts)\n* Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and\u002For in their future permanence in the study",{"count":64,"type":21},2000,"OBSERVATIONAL","The study is intended to cover two purposes: first, to develop a blood-based biomarker test for aiding the diagnosis of traumatic brain injury (TBI) in adult participants and for prognosis of outcome of TBI (CLIN12.1); and second, for monitoring the development of secondary events in adult participants diagnosed with TBI (CLIN12.2).",[27],"2026-06-26",{"date":70,"type":47},"2026-06-29",{"date":72,"type":47},"2026-02-09",{"date":74,"type":21},"2028-05-31",{"name":76,"class":77},"Hoffmann-La Roche","INDUSTRY",13,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":100,"locationsCount":102},"100595933","overground-virtual-reality-vr-gait-rehabilitation-for-traumatic-brain-injury-tbi-100595933","NCT07038889","Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)","Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)","Inclusion Criteria:\n\n* Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI), confirmed by the referring physician.\n* Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score ≥ 20, indicating sufficient cognitive function to participate in the study.\n* Exercise Clearance: Approval from a physician for participation in exercise-based interventions.\n* Rehabilitation Need: Demonstrates a need for functional rehabilitation.\n* Recent Therapy: Participants should not have received physical therapy (PT) within the last month.\n* Consent: Must be able to provide informed consent for themselves.\n\nExclusion Criteria:\n\n* Participants with unstable medication regimens that could interfere with their participation in the study.\n* Any comorbidity that could interfere with walking or gait training.\n* Participation in VR-assisted gait training within the last 6 months.\n* Intolerance to virtual reality environments or motion simulation.\n* Severe cognitive, visual, or hearing impairments where the participant cannot follow the therapist's instructions.\n* More than 135 kg total body weight.\n* More than 2.00 meters in body height.\n* Presence of open skin lesions or bandages in areas that would come into contact with the harness.\n* Functional Ambulation Category (FAC): Participants with an FAC score of less than 2 indicate they require physical support from more than one person to walk.\n\nClarification:\n\n\\- The diagnosis of TBI can be confirmed by their physician or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a physician to ensure it meets the study's medical criteria.",{"count":87,"type":21},30,[24],"The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury (TBI) improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for TBI patients.",[27],[92,93,27],"Gait Training","Virtual Reality","NOT_YET_RECRUITING","2026-06-24",{"date":68,"type":47},{"date":98,"type":21},"2026-07",{"date":51,"type":21},{"name":101,"class":54},"Indiana University",1,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":102},"100590158","assessment-of-traumatic-brain-injury-using-transcranial-magnetic-stimulated-evoked-potentials-100590158","NCT06963775","Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials","Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials (TMS-EEG)","(TMS-EEG)","Inclusion Criteria for Traumatic Brain Injury (Acute, Subacute, Chronic) group:\n\n1. Age 18 years and older\n2. Evidence of mechanical energy impacting the head or inertial forces affecting the head\n3. Either (A) or (B):\n\n   1. Trauma-related abnormality on CT scan on admission\n   2. If CT normal, documented\u002Fverified TBI based on evidence of either loss of consciousness, post-traumatic amnesia, confusion, or post-traumatic symptoms.\n\nExclusion Criteria for Traumatic Brain Injury (Acute, Subacute, Chronic) group:\n\n1. History of disabling pre-existing neurologic disease (Such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis)\n2. History of premorbid disabling condition that interfere with outcome assessments\n3. Bilaterally absent pupillary responses\n4. Penetrating traumatic brain injury\n5. Prisoners or patients in police custody\n6. Pregnancy\n7. Subjects with magnetic-sensitive devices implanted in their head or within 12 in. (30 cm) of the coil\u002Fprobe (examples: cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents and bullet fragments).\n\nInclusion Criteria for Healthy Control group:\n\n1. Age 18 years and older\n2. No history of TBI in the past 12 months\n\nExclusion Criteria for Healthy Control group:\n\n1. History of disabling pre-existing neurologic disease (Such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis)\n2. History of premorbid disabling condition that interfere with outcome assessments\n3. Prisoners or patients in police custody\n4. Pregnancy\n5. Subjects with magnetic-sensitive devices implanted in their head or within 12 in. (30 cm) of the coil\u002Fprobe (examples: cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents and bullet fragments).",true,{"count":113,"type":21},215,"Patients evaluated at Penn Presbyterian Medical Center for traumatic brain injury (TBI), who sign the informed consent, will undergo assessment of electrophysiologic potentials evoked by transcranial magnetic stimulation (TMS), using the Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel).",[27],[117,27,118,119],"TBI","TMS-EEG","neurological disorders",{"date":121,"type":47},"2026-06-25",{"date":123,"type":21},"2026-07-15",{"date":125,"type":21},"2030-07-31",{"name":127,"class":54},"Ramon Diaz-Arrastia",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":102},"100552800","improving-sleep-in-veterans-with-the-polytrauma-clinical-triad-100552800","NCT06477796","Improving Sleep in Veterans With the Polytrauma Clinical Triad","A Sleep Intervention to Improve Quality of Life and Symptom Management in Veterans With the Polytrauma Clinical Triad","LIONv2","Inclusion Criteria:\n\n* Veteran\n* English speaking with phone and internet access\n* Current self-reported sleep disturbances\n* Clinical stable for current pharmacologic or behavioral health treatments for depression, anxiety, sleep and pain\n* Documented history of TBI\n\nExclusion Criteria:\n\n* Decisional impairment and\u002For dementia\n* Current usage of a lightbox or negative ion generator\n* Shift work\n* History of macular degeneration and\u002For bipolar disorder\n* Evidence for suicidal ideation\n* Cancer diagnosis within the past 6 months\n* Surgery within the past 6 months\n* Substance abuse within the past 6-12 months\n* Significant impairing post-stroke residual hemiparesis","89 Years",{"count":138,"type":21},96,[24],"The \"polytrauma clinical triad\" (PCT), a highly disabling constellation of factors, is defined by the coexistence of traumatic brain injury, post-traumatic stress disorder, and chronic pain. Veterans with the PCT are medically complex, often refractory to conventional therapies, and suffer from additional related chronic sequela. Notably, sleep disturbances and cognitive impairment, which the investigators hypothesize are significant contributing factors to these functional impairments and an impediment toward rehabilitation. Thus, the investigators' research aims to intervene \"at the level of sleep\", and by improving sleep, improve these interconnected, disabling, and difficult to treat enduring complexities associated with the PCT - ultimately to improve Veteran quality of life, functional independence, and restorative function. The investigators predict that the proposed intervention, morning bright light therapy, which is cost-effective, rapidly deployable and home-based, will be effective in improving sleep and overall PCT symptom management, thereby, resulting in a measurable and impactful improvement in quality of life.",[27,142,143],"Post-traumatic Stress Disorder","Chronic Pain",[145,117,146],"polytrauma clinical triad","PTSD",{"date":70,"type":47},{"date":149,"type":47},"2025-05-01",{"date":151,"type":21},"2028-09-29",{"name":153,"class":154},"VA Office of Research and Development","FED",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":193,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100270060","neurologic-stem-cell-treatment-study-100270060","NCT02795052","Neurologic Stem Cell Treatment Study","Neurologic Bone Marrow Derived Stem Cell Treatment Study","NEST","Inclusion Criteria:\n\n1. Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.\n2. Be at least 6 months post-onset of the disease.\n3. If under current medical therapy (pharmacologic or surgical treatment) for the condition be considered stable on that treatment and unlikely to have reversal of the associated neurologic functional damage as a result of the ongoing pharmacologic or surgical treatment.\n4. In the estimation of Dr. Weiss and the neurologists have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.\n5. Be over the age of 18 and capable of providing informed consent.\n6. Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.\n\nExclusion Criteria:\n\n1. All patients must be capable of an adequate neurologic examination and evaluation to document the pathology. This will include the ability to cooperate with the exam.\n2. Patients must be capable and willing to undergo follow up neurologic exams with the sub-investigators or their own neurologists as outlined in the protocol.\n3. Patients must be capable of providing informed consent.\n4. In the estimation of Dr. Weiss the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function. .\n5. Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.\n6. Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.",{"count":164,"type":21},500,[24],"This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1\u002F3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http:\u002F\u002Fmdstemcells.com\u002Fnest\u002F",[168,169,170,171,172,27,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192],"Neurologic Disorders","Nervous System Diseases","Neurodegenerative Diseases","Neurological Disorders","Stroke","Cadasil","Chronic Traumatic Encephalopathy","Cerebral Infarction","Cerebral Ischemia","Cerebral Stroke","Cerebral Hemorrhage","Parkinson","Multi-System Degeneration","MSA - Multiple System Atrophy","Progressive Supranuclear Palsy","ALS","Amyotrophic Lateral Sclerosis","Neuropathy","Diabetic Neuropathies","Alzheimer Disease","Dementia","Frontotemporal Dementia","Lewy Body Disease","Cognitive Impairment","Lewy Body Variant of Alzheimer Disease",[194,195,172,27,196,197,185,198,176,191,188,199],"Neurologic Disease","Cerebral Vascular Accident","Multiple Sclerosis","Parkinsons Disease","Diabetic Neuropathy","Neurodegeneration",{"date":68,"type":47},{"date":202,"type":47},"2016-06",{"date":204,"type":21},"2028-07-31",{"name":206,"class":77},"MD Stem Cells",3,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":231,"locationsCount":102},"100638069","emotional-awareness-therapy-study-100638069","NCT07624825","Emotional Awareness Therapy Study","A Feasibility Study Exploring Emotional Health Training After Moderate to Severe Traumatic Brain Injury","TREAT","Inclusion Criteria:\n\n* Moderate or Severe TBI\n* ≥18 years old\n* ≥6 months post-TBI\n* Speaks and understands English\n* Medications that can influence mood should be stable (6+ weeks)\n* Elevated alexithymia\n* Demonstrate an understanding of the study and their rights (e.g. ability to answer the following questions correctly after a review of the study details during pre-screening process)\n\nExclusion Criteria:\n\n* Premorbid neurological disorder other than TBI\n* Degenerative neurologic condition\n* Active or uncontrolled major psychiatric disorder\n* Conditions that pose safety concern to self or others, such as suicide risk\n* Visual, hearing, communication, or cognitive impairments that would impede participation\n* Active involvement in an intensive rehabilitation program\n* Individuals who recently started psychotherapy and\u002For mental health counseling",{"count":217,"type":21},48,[24],"The purpose of this study is to learn about the potential benefits of two different training programs in helping improve emotional health and well-being in people who have had a traumatic brain injury.\n\nParticipants will be assigned to one of two programs based on the time since their injury. One of the programs will teach participants how to recognize and label emotions; the other will teach healthy ways of living. Participants may improve their emotional well-being and contribute to the knowledge needed to achieve better emotional health outcomes for people with TBI.\n\nFor eligible participants, the study includes 4 assessments. Assessments may take 30-60 minutes and will be done using secure videoconferencing, phone calls, and\u002For electronic surveys. The first assessment will ask questions about demographics, the participant's brain injury, and some medical history. All assessments will include questions about emotions, emotional awareness, resilience, loneliness, and how participants manage emotions, in addition to broader wellness questions and questions about how participants interact with others.\n\nRegardless of the program, the training includes 8 one-on-one sessions with a trained staff member over the course of about 1 month. Each session will last approximately 60-90 minutes. These sessions will start shortly after completing the first assessment. Preferably, participants will complete 1-2 training sessions a week, depending on availability and preference. These sessions will include education, discussion, and practice exercises.\n\nAfter the program is finished, participants will be asked to complete the same surveys completed at baseline for three follow-up time points (immediately following the program, 3 months after the program, and 6 months after). Total participation in the study will last approximately 8 months.",[27],[222,223,224],"Emotional Health Training","Severe Traumatic Brain Injury","Moderate Traumatic Brain Injury","2026-06-19",{"date":227,"type":47},"2026-06-23",{"date":229,"type":47},"2026-06-10",{"date":74,"type":21},{"name":232,"class":54},"Hackensack Meridian Health",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":239,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":243,"conditions":244,"keywords":245,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100428158","the-biomarkers-in-the-hyperbaric-oxygen-brain-injury-treatment-trial-biohobit-100428158","NCT04855396","The Biomarkers in the Hyperbaric Oxygen Brain Injury Treatment Trial (BioHOBIT)","Inclusion Criteria:\n\n* Enrolled in HOBIT (this is an ancillary study to the HOBIT Trial)\n\nExclusion Criteria:\n\n* Profoundly anemic (subjects who are profoundly anemic require blood transfusion)\n* Blood samples cannot be obtained","16 Years","65 Years",{"count":242,"type":21},150,"There are no therapeutic agents that have been shown to improve outcomes from severe traumatic brain injury (TBI). Critical barriers to progress in developing treatments for severe TBI are the lack of: 1) monitoring biomarkers for assessing individual patient response to treatment; 2) predictive biomarkers for identifying patients likely to benefit from a promising intervention. Currently, clinical examination remains the fundamental tool for monitoring severe TBI patients and for subject selection in clinical trials. However, these patients are typically intubated and sedated, limiting the utility of clinical examinations. Validated monitoring and predictive biomarkers will allow titration of the dose of promising therapeutics to individual subject response, as well as make clinical trials more efficient by enabling the enrollment of subjects likely to benefit. Glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL) and high sensitivity c-reactive protein (hsCRP) are promising biomarkers that may be useful as 1) monitoring biomarkers; 2) predictive biomarkers in severe TBI trials. Although the biological rationale supporting their use is strong, significant knowledge gaps remain. To address these gaps in knowledge, we propose an ancillary observational study leveraging an ongoing severe TBI clinical trial that is not funded to collect biospecimen. The Hyperbaric Oxygen in Brain Injury Treatment (HOBIT) trial, a phase II randomized control clinical trial that seeks to determine the dose of hyperbaric oxygen therapy (HBOT) that that has the highest likelihood of demonstrating efficacy in a phase III trial. The proposed study will: 1) validate the accuracy of candidate monitoring biomarkers for predicting clinical outcome; 2) determine the treatment effect of different doses of HBOT on candidate monitoring biomarkers; and 3) determine whether there is a biomarker defined subset of severe TBI that responds favorably to HBOT. This proposal will: 1) inform a go\u002Fno-go decision for a phase III trial of HBOT by providing adjunctive evidence of the effect of HBOT on key biological pathways through which HBOT is hypothesized to affect outcome; 2) provide evidence to support further study of the first monitoring biomarkers of severe TBI; 3) increase the likelihood of success of a phase III trial by identifying the sub-population of severe TBI likely to benefit from HBOT; 4) create a repository of TBI biospecimen which may be accessed by other investigators.\n\nThis study is related to NCT04565119",[27],[246,247,248,249,250],"Monitoring Biomarkers","Predictive Biomarkers","Glial Fibrillary Acidic Protein","Neurofilament Light Chain","High Sensitivity C-Reactive Protein","2026-06-17",{"date":253,"type":47},"2026-06-22",{"date":255,"type":47},"2021-01-19",{"date":257,"type":21},"2027-08-31",{"name":259,"class":54},"University of Michigan",11,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":111,"sex":269,"minAge":270,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":102},"100416894","university-of-pittsburgh-brain-health-initiative-100416894","NCT04708613","University of Pittsburgh Brain Health Initiative","Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players","BHI","Inclusion criteria:\n\nFormer professional football player\u002Fexposed group:\n\n1. Professional football retiree aged 29-59\n2. Played a minimum of 3 professional football seasons, with a minimum of 3 games in each season\n3. Fluent in English (translations are not available\u002Fvalidated for most neuropsychological tests)\n\nControl\u002Funexposed group:\n\n1. Age 29-59 male\n2. High school education or beyond\n3. Fluent in English (translations are not available\u002Fvalidated for most neuropsychological tests)\n\nExclusion criteria:\n\nControl\u002Funexposed group:\n\n1. Played organized football beyond high school\n2. History of severe TBI\n3. Current unstable cardiovascular disorder\n\nFor both groups:\n\n1. Prior history of psychosis (such as schizophrenia), or other major neurological disorder that would interfere with testing, in the opinion of the primary investigator.\n2. Contraindication to MR imaging, such as ferrous metal, pacemakers, or concerns about claustrophobia","MALE","29 Years","59 Years",{"count":273,"type":21},300,"This project will define the prevalence of brain health (i.e., normal cognitive, neuromotor, behavioral function) in living professional football retirees and group-matched controls through a comprehensive assessment of clinical, neuroimaging, and biomarker measures.",[27],[277,278,279,39],"Brain Health","Football","Contact Sport",{"date":253,"type":47},{"date":282,"type":47},"2019-11-18",{"date":284,"type":21},"2026-12",{"name":286,"class":54},"David Okonkwo, MD, PhD",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":102},"100642573","scale-up-evaluation-trial-of-the-diabetes-prevention-program-to-improve-obesity-and-cardiometabolic-health-after-traumatic-brain-injury-100642573","NCT07648901","Scale-Up Evaluation Trial of the Diabetes Prevention Program to Improve Obesity and Cardiometabolic Health After Traumatic Brain Injury","GLB Scale-Up","Inclusion Criteria:\n\n* 18-80 years of age\n\n  -≥6 months post-TBI\n* Moderate to severe TBI at time of injury\n* BMI ≥25 kg\u002Fm2\n* Able to communicate in English\n\nExclusion Criteria:\n\n* Contraindications to physical activity\n* Low cognitive function\n* Residing in hospital, acute rehab, SNF\n* Self-Reported Pregnancy\n* Pre-existing diagnosis of an eating disorder\n* Former DPP-GLB Participants (less than 6months since participation ended)","80 Years",{"count":296,"type":21},70,"The Investigators have proposed targeted efforts to address the feasibility, effectiveness, fidelity, and evaluation of the GLB-TBI Evidence Based Intervention (EBI) in a real world setting at a CDC-recognized site",[27,299,300],"Brain Injuries, Traumatic","Brain Injury, Chronic","2026-06-15",{"date":303,"type":47},"2026-06-16",{"date":305,"type":21},"2026-08-15",{"date":307,"type":21},"2028-08-30",{"name":309,"class":54},"Baylor Research Institute",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100633535","pastrami--patient-specific-statistics-for-microstructure-augmented-connectomics-100633535","NCT07527949","PASTRAMI : Patient-specific Statistics for Microstructure-augmented Connectomics","PASTRAMI","Inclusion Criteria:\n\n1. Aged 18 to 60\n2. Admitted for moderate to severe non-penetrating head injury (with a Glasgow Coma Scale score ≤ 12)\n3. On mechanical ventilation and under continuous sedation\n4. Enrolled in a social security program\n5. Whose family has been informed and has signed a voluntary, informed, written consent form\n\nExclusion Criteria:\n\n1. History of head trauma, stroke, or neurodegenerative diseases\n2. A decision to limit active treatment has already been made\n3. Quadriplegia\n4. Contraindications to MRI\n5. Protected individuals (adults under legal protection \\[judicial protection, guardianship, conservatorship\\], individuals deprived of liberty, pregnant women \\[self-reported\\], breastfeeding women, and minors).","60 Years",{"count":319,"type":21},100,[24],"Traumatic brain injury (TBI) represent a major public health issue, accounting for approximately 1.5 million hospital admissions annually across the European Union and 160,000 cases in France. They are a significant cause of mortality and disability, with serious consequences for patients and their families. Predicting functional outcomes remains complex due to the heterogeneity of brain injuries, whether primary or secondary, as well as the mechanisms involved, particularly neuroinflammation. This difficulty is particularly pronounced for moderate to severe TBI, for which current predictive tools are still limited.\n\nThe PASTRAMI project proposes to utilise diffusion magnetic resonance imaging (MRI) to identify biomarkers associated with axonal lesions in the white matter. This technique enables the analysis of brain microstructure and the reconstruction of neural connections (connectome), thereby offering innovative prospects for improving the prediction of functional recovery.\n\nThis is a prospective, multicentre, interventional study involving 100 patients aged between 18 and 60 years with moderate to severe traumatic brain injury. The primary objective is to assess the prognostic value of brain microstructural measures at baseline, by correlating them with the GOSE functional score at 1 year. Secondary objectives include the analysis of mortality, functional outcome, quality of life, and early physiological factors influencing progression.\n\nPatients will undergo a standard MRI scan supplemented with additional sequences for prognostic purposes, without any change to their therapeutic management. The associated risks are minimal and relate primarily to the MRI scan. No immediate individual benefit is expected, but the results could improve our understanding of brain lesions and optimise future management.\n\nThe total duration of the study is 48 months. The expected outcomes include better characterisation of lesions and improved predictive tools, contributing to more appropriate clinical decisions.",[27,323],"Magnetic Resonance Imaging (MRI)","2026-06-11",{"date":326,"type":47},"2026-06-12",{"date":328,"type":21},"2026-09-01",{"date":330,"type":21},"2030-09-01",{"name":332,"class":54},"Rennes University Hospital",2,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":239,"maxAge":4,"enrollmentInfo":341,"targetDuration":343,"studyType":65,"phases":4,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":102},"100643795","bridge-us-bridging-readiness-in-deployed-neurotrauma-gaps-for-excellence-100643795","NCT07636213","BRIDGE-US: Bridging Readiness in Deployed Neurotrauma Gaps for Excellence","BRIDGE-US","Inclusion Criteria:\n\n1. Age: Subjects aged 16 years and older\n2. Injury Type\u002FEvidence: Patients with a confirmed PBI as demonstrated by head imaging or physical exam (evidence of dural penetration by a projectile)\n3. Timeframe: Patients must be enrolled within 8 hours of injury\n\nExclusion Criteria:\n\nNo subjects will be excluded based on gender or ethnicity for this study. Subjects under the age of 16 will be excluded. These subjects differ significantly in terms of neurodevelopment, physiology, and trauma response, which introduces heterogeneity that could confound study results. Additionally, pediatric PBI has distinct etiologies, treatment pathways, and prognostic indicators compared to adult PBI (note that age 16 and up are treated medically as adults).\n\nFULL EXCLUSION CRITERIA:\n\n1. Dead on Arrival (DOA): Patients who receive CPR with no return of pulse\n2. Non-penetrating injury: Patients with head injuries that do not include dural penetration\n3. Polytrauma: Patients with penetrating or blunt injuries to other parts of the body\n4. Known or suspected pregnancy\n5. Known or suspected prisoner",{"count":342,"type":21},270,"7 Days","The purpose of this research study is to prospectively collect biospecimens, imaging, and clinical data from patients with penetrating brain injuries across high-volume PBI sites in the US (including UChicago). Biospecimens will undergo biomarker analysis - biomarker data specific to PBI is extremely limited, and could provide critical insight to outcome identification and clinical decision making.\n\nThis data will be used to build the first comprehensive PBI Data Commons, biorepository, and imaging repository which will create the infrastructure necessary to close critical knowledge gaps, advance biomarker discovery specific to PBI, and provide the foundation for future research aimed at improving prognostication and treatment for patients with this devastating injury.",[346,347,348,27],"Brain Injuries, Acute","Brain Trauma","Penetrating Head Injury","2026-06-08",{"date":351,"type":47},"2026-06-09",{"date":353,"type":21},"2026-07-01",{"date":355,"type":21},"2035-12-31",{"name":357,"class":54},"University of Chicago",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":377,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":385,"leadSponsor":387,"locationsCount":102},"100642991","home-based-vision-rehabilitation-guided-by-brain-imaging-100642991","NCT07635329","Home-based Vision Rehabilitation Guided by Brain Imaging","Behavioral Rehabilitation Through Image-Guided Home-based Training","BRIGHT","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Capable of providing informed consent and complying with study procedures.\n3. Unilateral or bilateral focal brain damage causing visual field loss.\n4. At least three months post-stroke or traumatic brain injury, or a stable brain tumor within the past year.\n5. Eligible for MRI based on standard safety screening.\n\nExclusion Criteria:\n\n1. Severe neurological or psychiatric conditions unrelated to the focal lesion that may interfere with study participation or data interpretation.\n2. Current or recent (within the past 6 months) drug or alcohol abuse or addiction as defined by DSM-5.\n3. Ocular disease or disorder.",{"count":319,"type":21},[24],"The BRIGHT (Behavioral Rehabilitation Through Image-Guided Home-based Training) study aims to evaluate the effectiveness of image-guided, home-based perceptual training at improving visual performance in individuals with visual field loss.\n\nUsing a prospective, crossover design, BRIGHT combines visual behavioral testing, neuroimaging, and a home-based intervention. It aims to 1) identify neural pathways that support training-induced visual plasticity; and 2) compare the efficacy of different types of visual training delivered in a home-based setting.",[370,172,371,372,373,374,375,27,376],"Visual Field Defect","Hemianopia Homonymous","Quadrantanopia","Cortical Blindness","Visual Field Defect, Peripheral","Visual Field Loss","Brain Tumor",[378,379,380,117,381],"neuroplasticity","stroke","vision","brain tumor","2026-06-03",{"date":351,"type":47},{"date":353,"type":21},{"date":386,"type":21},"2030-03-31",{"name":388,"class":54},"Georgetown University",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":396,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":400,"conditions":401,"keywords":406,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":102},"100637740","brain-blood-flow-and-cerebral-autoregulation-monitoring-in-critically-ill-children-100637740","NCT07613918","Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children","Transcranial Doppler Assessment of Cerebral Autoregulation and Blood Flow Velocity Patterns in Critically Ill Children: A Prospective Observational Study","Inclusion Criteria:\n\n* Has at least one Parent or Legal Guardian who is willing and able to provide informed consent in English\n* Mechanically ventilated (Endotracheal tube)\n* Indwelling arterial catheter\n* Current patient in the American Family Children's Hospital PICU.\n* 1 day to 17.5 years of age\n\nExclusion Criteria:\n\n* Subjects with a known or obvious anatomic barrier preventing safe application of the transcranial Doppler probe (e.g., cranial dressings, cranial fixation hardware, ventricular access devices positioned over insonation sites, or bilateral craniectomies)\n* Patient with known chronic hypertension\n* Admission FSS score \\> 16\n* Tracheostomized patient\n* The designated sub-investigator (Dr. Talal Al Hendawi) and PI (Dr. Neil Munjal) are unavailable to perform the Transcranial Doppler scan at the time of eligibility. All study scans are performed by either Dr. Al Hendawi or Dr.Munjal to ensure standardization and data integrity. Therefore, if they are unavailable (e.g., due to clinical service, leave, or other scheduling constraints), the patient will not be enrolled in the study.\n* Not suitable for study participation due to other reasons at the discretion of the investigators","1 Day","17 Years",{"count":399,"type":21},125,"This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit (PICU). TCD is already used for clinical reasons in many children, but it is not part of routine monitoring for every critically ill child. By using TCD, the investigators hope to better understand how brain blood flow changes during illness. They will also track children's functional status from before their illness to the time of PICU discharge to explore how brain blood flow patterns relate to neurological outcomes.125 participants will be enrolled and will be on study while in the PICU, estimated to be 3-14 days.",[402,403,404,27,405],"Critical Illness","Pediatric Critical Illness","Respiratory Failure","Cardiac Arrest",[407,408,409,410,411,412,413,414,415,416,417,418],"PICU","infant","Transcranial Doppler Assessment","Cerebral Autoregulation","Blood Flow Velocity","children","mechanical ventilation","neurocritical care","pulsatility index","Mean flow index","neonate","pediatric critical care","2026-06-02",{"date":421,"type":47},"2026-06-04",{"date":423,"type":21},"2026-06",{"date":425,"type":21},"2028-05",{"name":427,"class":54},"University of Wisconsin, Madison",{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":440,"conditions":441,"keywords":444,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":207},"100640910","phase-2-feasibility-and-safety-of-targeting-neutral-vs-liberal-fluid-balance-in-traumatic-brain-injured-patients--limit-tbi-trial-100640910","NCT07625995","Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial","Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients: a Phase II Randomized Controlled Trial - LIMIT-TBI Trial","LIMIT-TBI","Inclusion Criteria:\n\n* Adult patients with traumatic brain injury (isolated or associated with extracranial injuries), with or without intracranial pressure monitoring\n* Admission to the intensive care unit\n* Age \\>18 years\n* Enrollment within 48 hours after ICU admission\n\nExclusion Criteria:\n\n* Enrollment in another clinical trial not approved for co-enrollment\n* Pregnancy or suspected pregnancy\n* Concomitant hemorrhagic shock expected to require surgical treatment within 24 hours from inclusion or requiring massive transfusion protocol\n* Hemodynamic instability at ICU admission, defined as heart rate \\>120 beats\u002Fmin and systolic arterial pressure \\\u003C100 mmHg despite at least 1 L of fluid resuscitation, or requirement for high-dose norepinephrine (\\>0.5 mcg\u002Fkg\u002Fmin) or any inotropic support\n* Need for continuous venovenous hemodiafiltration (CVVHDF) at admission\n* Expected survival \\\u003C48 hours",{"count":437,"type":21},88,[439],"PHASE2","The LIMIT-TBI trial is a multicenter, international, randomized, phase II clinical trial designed to evaluate the feasibility and safety of targeting a neutral fluid balance compared to standard care in critically ill adult patients with traumatic brain injury (TBI).\n\nFluid therapy is a cornerstone of TBI management, but optimal fluid balance remains uncertain, with both fluid overload and restriction potentially leading to adverse outcomes. This study aims to determine whether maintaining a daily fluid balance close to zero (±500 mL) during the first 5 days of ICU admission is achievable and safe.\n\nParticipants will be randomized within 48 hours of ICU admission to either a protocolized neutral fluid balance strategy or standard care. Outcomes include feasibility of achieving the target balance, organ complications, hemodynamic parameters, ICU resource utilization, and mortality and neurological outcomes up to 6 months.",[27,223,442,443],"Acute Brain Injury","Neurocritical Care",[445,446,447,448,449],"Fluid Balance","Fluid Therapy","Hemodynamic Management","Feasibility Study","Intracranial Pressure","2026-05-30",{"date":421,"type":47},{"date":453,"type":47},"2025-07-01",{"date":455,"type":21},"2029-02",{"name":457,"class":54},"Erasme University Hospital",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":239,"maxAge":240,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":260},"100240350","phase-2-hyperbaric-oxygen-brain-injury-treatment-trial-100240350","NCT02407028","Hyperbaric Oxygen Brain Injury Treatment Trial","Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial","HOBIT","Inclusion Criteria:\n\n* Age 16 years or older and 65 years or younger\n* Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to 8.\n* Marshall computerized tomography (CT) score \\>1 in patients with a GCS of 7 or 8 or patients with an alcohol level \\>200 mg\u002Fdl\n* Ability to initiate the first hyperbaric oxygen treatment within 8 hours of admission in patients not requiring a craniotomy\u002Fcraniectomy or any other major surgical procedure OR\n* Ability to initiate the first hyperbaric oxygen treatment within 14 hours of admission in patients requiring a craniotomy\u002Fcraniectomy or major surgical procedure\n\nExclusion Criteria:\n\n* First hyperbaric oxygen treatment cannot be initiated within 24 hours of injury\n* GCS of 3 with mid-position and non-reactive pupils bilaterally (4mm)\n* Penetrating head injury\n* Pregnant\n* Pre-existing neurologic disease (e.g. TBI or stroke or neurodegenerative disorder) with confounding residual neurologic deficits\n* Unstable acute spinal cord injury\n* Fixed coagulopathy\n* Severe hypoxia\n* Cardiopulmonary resuscitation performed\n* Coma suspected to de due to primarily non-TBI causes\n* Any contraindications to the study intervention",{"count":467,"type":21},200,[439],"The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.",[27],"2026-05-29",{"date":419,"type":47},{"date":474,"type":47},"2018-06-25",{"date":476,"type":21},"2029-06-30",{"name":478,"class":54},"Gaylan Rockswold",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":269,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":488,"briefSummary":489,"conditions":490,"keywords":493,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":497,"leadSponsor":499,"locationsCount":102},"100637110","examining-the-efficacy-of-the-man-therapy-platform-in-reducing-problematic-anger-among-military-service-members-with-and-without-a-tbi-history-100637110","NCT07604701","Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History","Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Military service member\n* Identify as male\n* Aged 18+ years\n* Positive problematic anger screen (DAR-3 \\>8)\n* Ability to read, write, and speak English\n\nExclusion Criteria:\n\n* Active psychosis or acute mania necessitating clinical intervention\n* Acute thoughts of self- or other-harm necessitating imminent clinical intervention (e.g., hospitalization)\n* Unable to provide informed consent",{"count":487,"type":21},226,[24],"The goal of this randomized controlled trial is to determine if an interactive digital solution, Man Therapy, reduces indices of problematic anger in male military service members who screen positive for problematic anger.\n\nThe man questions this study aims to answer are:\n\n* Does Man Therapy reduce indices of problematic anger?\n* Does Man Therapy reduce psychosocial correlates of anger?\n\nResearchers will also examine if the effects of those aims differ based on a participant's history of a mild TBI, the mechanism of a primary mild TBI, and\u002For the number of mild TBIs.\n\nResearchers will compare Man Therapy to a waitlist control. This will help determine if Man Therapy works better than no treatment.\n\nParticipants will:\n\n* Complete a baseline survey\n* Be randomized to intervention or waitlist control\n* If randomized to intervention, participants will receive the intervention and complete a survey immediately after the intervention and at 1-, and 3-months following the intervention\n* If randomized to waitlist control, participants complete surveys at 1-, and 3-months and have the opportunity to complete the intervention following the 3-month survey",[491,27,492],"Mild Traumatic Brain Injury (mTBI)","Anger",[27,492],"2026-05-26",{"date":471,"type":47},{"date":328,"type":21},{"date":498,"type":21},"2028-12-01",{"name":500,"class":54},"University of Colorado, Denver",{"id":502,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":25,"conditions":505,"keywords":506,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":510,"leadSponsor":512,"locationsCount":55},"100490200",{"count":20,"type":21},[24],[27,28,29,30,31,32,33,34,35,36],[27,28,38,29,39,35,40,41,42],{"date":508,"type":47},"2026-05-28",{"date":49,"type":47},{"date":511,"type":21},"2026-09",{"name":53,"class":54},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":111,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":524,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":532,"leadSponsor":534,"locationsCount":4},"100592172","treating-traumatic-brain-injury-with-transcranial-direct-current-stimulation-100592172","NCT06989970","Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation","Inclusion Criteria:\n\n* Diagnosis of traumatic brain injury (TBI) at least 2 years prior to participation\n* Right-handed\n* English - speaking\n\nExclusion Criteria:\n\n* Uncorrected visual impairment\n* Uncorrected hearing impairment\n* Stroke or other premorbid neurological disorders affecting the brain\n* Premorbid learning disorders\n\nMRI Exclusion Criteria:\n\n* severe claustrophobia\n* Cardiac pacemakers, ferromagnetic implants, cochlear implants\n* pregnant woman",{"count":520,"type":21},20,[24],"Traumatic Brain Injury (TBI) often results in a wide array of cognitive impairments, which can significantly diminish quality of life for affected individuals. While traditional rehabilitation methods typically adopt a standardized approach, it's crucial to acknowledge the significant heterogeneity within the TBI patient population. Neglecting these variations reduces the likelihood of otherwise effective treatments being considered for widespread adoption. Emerging evidence highlights the potential of transcranial direct current stimulation (tDCS) as a promising adjunctive therapy. tDCS, a noninvasive and safe neuro-rehabilitative procedure, has shown efficacy when integrated with cognitive training across various neurological disorders, such as depression, post-stroke aphasia, and neurodegenerative conditions.\n\nThis study aims to investigate the effectiveness of tDCS paired with behavioral therapy, particularly cognitive training, in improving cognition and executive function in chronic TBI patients. Additionally, tDCs targets in the current study will be tailored to each individual patient, recognizing the patient's unique needs and circumstances",[27],[117,27,525,526,527,528],"Chronic Traumatic Brain Injury","transcranial direct current stimulation","tDCS","Computerized Cognitive Therapy","2026-05-21",{"date":494,"type":47},{"date":301,"type":21},{"date":533,"type":21},"2029-10-15",{"name":53,"class":54},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":271,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":547,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":557,"locationsCount":55},"100457393","control-network-neuromodulation-to-enhance-cognitive-training-in-complex-traumatic-brain-injury-100457393","NCT05236010","Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury","CONNECT-TBI","Inclusion Criteria:\n\nThere will be no gender restrictions with regard to sample inclusion. Veterans and Warfighters will be enrolled in this study if they 1) are aged 18-59; 2) have suffered a mild TBI with documented evidence of alteration in neurological functioning or loss of consciousness (LOC) which was less than 30 minutes; 3) were injured between 3 months and 5 years ago; 4) experienced less than 24 hours of post-traumatic amnesia (PTA); 5) have subjective post-TBI cognitive deficits as assessed by the NSI, with at least 1 of 4 cognitive symptoms at a score of 3 or higher (severe disturbance) or at least 2 of 4 cognitive symptoms at a score of 2 or higher (moderate disturbance). This is the target population as identified by the grant mechanism, with chronic cognitive impairments from mild traumatic brain injury. The age range of 18-59 years was selected because the investigators did not want to include developmental processes in analyses and by 18 years old, many major neurodevelopmental changes in the brain will have taken place. Using similar rationale, the investigators chose to include participants up to the age of 59 because they do not want to include advancing age-related brain changes in our analyses. They will also be 6) fluent in English, as the testing and intervention are all conducted in English; and 7) will have been on stable doses of any psychotropic medications for the past 2 months, so as to avoid confounding of results by medication effects. It is expected that the sample included in this study will reflect the demographics of the greater Albuquerque and Twin Cities metropolitan communities.\n\nExclusion Criteria:\n\nVeterans will be excluded from participation in this study if there is 1) a prior history of other neurological disease or any history of seizures beyond immediate post-traumatic seizure, so as to reduce risk of exacerbation of epilepsy or other neurological symptoms; 2) history of psychosis, so as to reduce risk of psychiatric decompensation; 3) history of current or recent (within two years) substance\u002Falcohol dependence, to reduce confounding effects on cognition; 4) any discontinuity in skull electrical conductivity (i.e., unhealed burr holes in scalp) or artificially constructed (metal or plastic) craniotomy cover, to reduce risk of unimpeded electrical current; 5) presence of any implanted metal or electrical device (e.g. pacemaker), to reduce risk of heating during MRI, or device malfunction during neuromodulation; 6) recent medical hospitalization (within three weeks), to reduce risk of medical decompensation during the study; 7) any condition that would prevent the participant from completing the protocol, such as significant agitation; 8) appointment of a legal representative, as assessed via direct inquiry of the participant or a designated trusted other, to avoid coercion of a vulnerable population; 9) any significant hardness of hearing or blindness that would make completing the cognitive training not possible; 10) any ongoing litigation related to TBI, to prevent interference with legal proceedings; 11) any other contraindication to exposure to strong magnetic fields or MRI, such as severe claustrophobia; 12) pregnant women will be excluded as the effects of MRI and brain stimulation on developing fetuses are unknown; 13) membership in an identified vulnerable population, including minors, and prisoners, and adults unable to consent due to cognitive impairment will be excluded, as they will be unlikely to be able to complete study procedures. Prisoners will be excluded from the study to avoid coercion; 14)received a Glasgow coma scale (GCS) less than 13 or greater than 15 upon ED admission, if available in patient's records.\n\nThe investigators do not intend to include adults who are unable to consent in this study.\n\nThe investigators do not intend to include individuals who are not yet adults (infants, children, teenagers) in this study.\n\nThe investigators do not intend to include pregnant women in this study.\n\nThe investigators do not intend to include prisoners in this study.",{"count":543,"type":21},108,[24],"The CONNECT-TBI Trial aims to develop safe, effective treatments for complex mTBI that improve cognitive functioning. Based on the compelling preliminary data generated by our study team, the objective of this study is to conduct a randomized, double-blinded, sham-controlled Phase II clinical trial of APT-3 combined with rTMS, HD-tDCS, or sham to treat cognitive control deficits in Veterans with complex mTBI and PPCS. At the Baseline Visit, participants will undergo demographic, neuropsychological, behavioral, and quality of life testing. They will also undergo structural MRI to permit modeling of their brain, resting\u002Ftask-related fMRI to identify the CCN, and pseudocontinuous arterial spin labeling (pCASL) and diffusion tensor imaging (DTI) to assess for other pathologies. They will then be randomized to 16 sessions of APT-3 with concurrent rTMS, HD-tDCS, or sham stimulation delivered to the unique functional left dorsolateral prefrontal cortex (DLPFC), a primary node of the CCN. Lastly, they will repeat all baseline tests, and report on 3- and 6-month recovery levels to establish longevity and stability of subjective benefit. Given that this individualization protocol has never been attempted for cognitive rehabilitation in military mTBI, we expect this trial will generate useful effect sizes for HD-tDCS and rTMS to be used for powering the next step, a Phase III multi-center trial.",[27],[27,548,549,550,551],"mTBI","Prolonged Post Concussive Symptoms","Brain Stimulation","Cognitive Rehabilitation","2026-05-20",{"date":494,"type":47},{"date":555,"type":47},"2022-01-21",{"date":353,"type":21},{"name":558,"class":54},"University of New Mexico",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":240,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":102},"100557922","rapid-treatment-of-ptsd-with-accelerated-non-invasive-brain-stimulation-100557922","NCT06544408","Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation","Inclusion:\n\n1. Adults age 18 years to 65 years old.\n2. Meets DSM-5 criteria for PTSD with a PCL-5 score \\> 33\n3. No changes in psychotropic medication (if taking psychotropic medication) and\u002For changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of trial.\n4. Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study\n\nExclusion:\n\n1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).\n2. Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment.\n3. Dementia or other cognitive disorder making unable to engage in treatment.\n4. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness that precludes safe participation in trial.\n5. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.\n6. OCD cannot be the primary disorder but can have OCD symptoms.\n7. Inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)\n8. Current, planned, or suspected pregnancy\n9. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)\n10. Severe Traumatic Brain Injury\n11. We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments.\n12. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).\n13. Prior known active TMS of dorsolateral prefrontal cortex or dorsomedial prefrontal cortex or electroconvulsive therapy (ECT) -",{"count":566,"type":21},132,[24],"This study will test the clinical efficacy of an accelerated TMS (accel-TMS) protocol that rapidly addresses PTSD symptoms with 1 week (25 sessions over 5 days) of condensed treatment.",[570,27],"Post Traumatic Stress Disorder",[146,572,573],"TMS","Transcranial Magnetic Stimulation","2026-05-18",{"date":552,"type":47},{"date":577,"type":47},"2024-11-06",{"date":579,"type":21},"2028-12-30",{"name":581,"class":54},"Florida State University",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":239,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":595,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":102},"100637794","fareon-open-label-device-clinical-trial-100637794","NCT07600320","Fareon Open Label Device Clinical Trial","Microtesla Magnetic Therapy (MMT) Treatment of Cognitive Impairment: Open Label Pilot Study","IncInclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Any sex\u002Fgender\n* 16 years of age or older\n* English Speaking\n* Experiencing symptoms of at least self-reported mild cognitive impairment associated with a confirmed diagnosis of a condition such as Long COVID, Traumatic Brain Injury, other Acquired Brain Injuries, and other neurodegenerative diagnoses including but not limited to Alzheimer's disease\n* Individuals of childbearing age agreeing to use a highly effective form of birth control for the duration of their participation\n* Willing and able to sign informed consent or have a parent or LAR able to sign informed consent form\n* Willing and able to attend all study visits virtually or in person\n\nExclusion Criteria:\n\nIndividual who meets any of the following criteria will be excluded from participation in this study:\n\n* Enrollment in another interventional clinical trial in the last 90 days or during the study period\n* Change in anti-depressant or other psychoactive medication or dose in the last 90 days\n* Cranially implanted devices or metal\n* Pacemaker\n* History of seizure disorder\n* Pregnant or plan to become pregnant during the study as indicated by proof of a positive pregnancy test\n* Inability to achieve appropriate positioning of the study device on the head\n* Any medical, psychiatric, or neurological condition, or concurrent treatment, that in the opinion of the Principal Investigator would interfere with study participation, interpretation of results, or pose additional risk to the participant.",{"count":87,"type":21},[24],"The purpose of this study is to assess the safety and feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to acquired brain injury, Long COVID, traumatic brain injury, myalgic encephalomyelitis (ME\u002FCFS), and other neurodegenerative diagnoses including but not limited to Alzheimer's disease and to collect data on safety and efficacy to inform the design of larger clinical studies.",[593,594,27],"Cognitive Dysfunction","Acquired Brain Injury",[596,597,598,599],"Long COVID","Myalgic encephalomyelitis\u002FChronic fatigue syndrome","Neurodegenerative","Alzheimer's disease","2026-05-14",{"date":552,"type":47},{"date":603,"type":21},"2026-05-01",{"date":605,"type":21},"2027-04-30",{"name":607,"class":54},"Icahn School of Medicine at Mount Sinai",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":617,"briefSummary":619,"conditions":620,"keywords":621,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":630,"locationsCount":102},"100530560","early-phase-1-improving-traumatic-brain-injury-rehab-care-with-comm-health-services-a-research-project-within-the-tbi-model-system-100530560","NCT06188364","Improving Traumatic Brain Injury Rehab Care With Comm Health Services: a Research Project Within the TBI Model System","Improving Traumatic Brain Injury Rehabilitation Care Transitions With Community Health Services: A Randomized Clinical Trial (CHW Intervention for TBI Care Transitions [CHWI for TBI]), a Research Project Within the TBI Model System","Inclusion Criteria:\n\n* Participants must be adults (age 18 or older).\n* Must be primary person responsible for supervision\u002Fcare needs of person with TBI post-IRF discharge.\n* The person with TBI must have been admitted to the Brain Injury Service Unit at SAI.\n* If the care partner does not live in the same residence as the person with TBI, they must provide multiple daily check-ins on day-to-day care.\n* Must agree to use mHealth (texts, calls) and possess or be eligible to acquire a smart phone.\n\nExclusion Criteria:\n\n* Any severe cognitive impairment that precludes the ability to provide informed consent or safely function as the care partner for a vulnerable adult with TBI.",{"count":616,"type":21},126,[618],"EARLY_PHASE1","TBI rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. Persons with TBI have heterogenous neurological impairment (cognitive and behavioral foremost, along with motor, sensory, and balance), that limits their functional independence and participation, and increases their risk for secondary medical conditions, injuries, rehospitalizations and early mortality",[27],[622,623,624],"Community Health Services","Rehabilitation Care Transitions","Caregiver Supports","2026-05-12",{"date":600,"type":47},{"date":628,"type":47},"2024-04-26",{"date":257,"type":21},{"name":631,"class":54},"Virginia Commonwealth University",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":638,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":22,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":102},"100530945","parent-child-interaction-therapy-pcit-for-children-with-traumatic-brain-injury-tbi-a-stepped-care-model-100530945","NCT06193382","Parent-Child Interaction Therapy (PCIT) for Children With Traumatic Brain Injury (TBI): A Stepped-Care Model","Child Inclusion Criteria:\n\n* Child is between the ages of 2 and 7\n* Child has a mild to moderate TBI\n\nPrimary Caregiver Inclusion Criteria:\n\n* Primary caregiver is 18 years or older\n* Primary caregiver speaks and reads in either English or Spanish\n\nChild Exclusion Criteria:\n\n\\- Children with major sensory impairments (e.g., deafness, blindness)\n\nPrimary Caregiver Exclusion Criteria:\n\n\\- Primary caregiver with major sensory impairments (e.g., deafness, blindness)","2 Years",{"count":520,"type":21},[24],"The purpose of this study is to understand how a stepped-care model of Parent-Child Interaction Therapy (Step-Up PCIT) addresses child behavioral problems among children between the ages of 2 and 7 with a traumatic brain injury (TBI).",[27,643],"Disruptive Behavior","2026-05-07",{"date":625,"type":47},{"date":647,"type":21},"2026-11-01",{"date":649,"type":21},"2027-01-30",{"name":651,"class":54},"University of Miami",{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":4,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":659,"targetDuration":4,"studyType":22,"phases":660,"briefSummary":661,"conditions":662,"keywords":663,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":669,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":673,"locationsCount":102},"100508221","clinical-feasibility--validation-of-the-augmented-reality-glenxrose-acquired-brain-injury-rehabilitation-programs-100508221","NCT05897593","Clinical Feasibility & Validation of the Augmented Reality GlenxRose Acquired Brain Injury Rehabilitation Programs","Clinical Feasibility & Validation of the Augmented Reality-Delivered GlenxRose Programs for Acquired Brain Injury","Inclusion Criteria:\n\n* Adults receiving care at the Glenrose Rehabilitation Hospital (Edmonton, Canada) for mild to moderate Acquired Brain Injury\n* Proficiency in English\n* Adequate upper-limb strength and coordination to utilize AR headset (determined by clinicians)\n\nExclusion Criteria:\n\n* Pediatric populations\n* Severe acquired brain injury\n* severe cognitive and behavioural disorders (e.g. agitation, confusion, aggressive behaviour), which is Level V or higher on the Rancho Los Amigos Levels of Cognitive Functioning Scale\n* Severe aphasia, impacting language comprehension\n* Communication disorders that impact comprehension of verbal commands and understanding of scale used in the study\n* Previous neurological and\u002For psychiatric disorders\n* Substance misuse disorders\n* Previously acquired brain injury\n* Impairments that limit the interaction with the AR device",{"count":87,"type":21},[24],"Factors related to successful rehabilitation in acquired brain injury (ABI) are often directly related to adherence; for instance, dosage, frequency, and intensity can burden the patient regarding time and motivational factors. Regarding salience, patients may lose interest or find a traditional intervention boring after a few sessions. It is well documented that nonadherence not only impacts rehabilitation for patients but can also further prolong treatment, and increase hospital and clinician costs, in addition to a higher prevalence of future comorbidities. Additionally, the same factors that are related to can impact adherence are also related to neuroplasticity. Therefore, strategies that improve patient adherence can significantly help optimize patient care and treatment outcomes for those with ABI.\n\nThe gamification of rehabilitation therapies using augmented reality (AR) may help promote adherence. Gamification of rehabilitation therapy can make mass practice required in rehabilitation therapies seemingly fun and more personally engaging for the patient. Additionally, the experience achieved through AR can further promote salience and be customizable to individual patient requirements. As AR systems are now highly portable, cost-effective, and relatively simple to utilize, they can provide an excellent opportunity to provide more engaging rehabilitation approaches compared to standard care alone. AR gamification of rehabilitation may increase adherence by shifting patients' perspectives of therapy as tedious, boring, or a hassle, to a fun and engaging game that ultimately helps their recovery processes.\n\nThe GlenXRose AR-delivered ABI program (developed by the Cognitive Projections Lab, University of Alberta) has been created in collaboration with the Glenrose Rehabilitation Hospital with the overall goal of increasing patient adherence, treatment outcomes, and satisfaction with ABI rehabilitation therapy. The proposed studies are to investigate the feasibility of implementing this technology alongside routine clinical care, obtaining clinician feedback, examining associated financial costs, and continuing to examine the effect of the GlenXRose AR ABI-therapies on patient adherence and clinical outcomes, compared to traditional clinical care alone.",[594,172,27],[664,665,93,666,40,172,667,668],"Augmented Reality","AR","VR","Rehabilitation","Occupational Therapy",{"date":625,"type":47},{"date":671,"type":21},"2026-08-01",{"date":257,"type":21},{"name":674,"class":54},"University of Alberta"]