[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-traumatic-brain-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-traumatic-brain-injury":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,43,0,25,[9,51,80,103,131,157,186,210,239,267,289,319,347,374,397,433,465,487,508,544,575,598,625,656,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100054323","rehabilitation-education-and-self-management-for-adolescents-after-mild-traumatic-brain-injury-100054323",false,"NCT07698015","Rehabilitation, Education, and SElf-management for Adolescents After Mild Traumatic Brain Injury","A Decentralized, Investigator Blinded, Randomized, Parallel-group Study to Determine the Feasibility of an 8-week Smart-phone App Delivered Mindfulness- Based Intervention Versus a Health Education Program for Adolescents With Persisting Symptoms After Concussion\u002FmTBI","RESET","Inclusion Criteria:\n\n1. Age 12-18\n2. Structured interview confirming a concussion\u002FmTBI or suspected concussion\u002FmTBI diagnosis according to the American Congress of Rehabilitation Medicine definition\n3. Concussion\u002FmTBI occurred 1-12 months prior to randomization\n4. Persisting symptoms after concussion as demonstrated by a score \\>75th percentile on the Health and Behaviour Inventory compared to orthopedic injury normative group\n5. English proficiency\n\nExclusion Criteria:\n\n1. Parent- or self-reported psychiatric hospitalization in past year or prior diagnosis of a psychiatric disorders or psychiatric symptoms that may be contraindicated for mindfulness-based interventions (e.g., psychosis)\n2. Participation in a clinical trial using the Dawn intervention app in acute concussion (e.g., \\\u003C2 weeks post-injury).","ALL","12 Years","18 Years",{"count":22,"type":23},72,"ESTIMATED","INTERVENTIONAL",[26],"NA","Concussion or mild traumatic brain injury (mTBI) is a major public health concern. Most adolescents will recover from mTBI without complication; however, a sizeable minority experience symptoms that last more than one most post-injury (i.e., persisting symptoms after concussion). Few evidence-based treatments exist for adolescents with persisting symptoms after concussion. Mindfulness-based interventions (MBIs) are effective for treating a wide range of mental and physical health conditions that overlap with post-concussion symptoms. Participants will participate in an 8-week smartphone app-based MBI or a health education program as a control. The study will determine the practicality of doing a larger study to evaluate the effectiveness of the MBI by assessing participants' level of interest, view of intervention helpfulness, and their completion of all the components of the study.",[29,30,31],"Brain Concussion","Mild Traumatic Brain Injury","Concussion",[33,34,35,36,37],"concussion","mild traumatic brain injury","mindfulness-based intervention","digital health","persisting symptoms after concussion","NOT_YET_RECRUITING","2026-07-06",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":23},"2026-09-01",{"date":46,"type":23},"2028-05-31",{"name":48,"class":49},"Molly Cairncross","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":24,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100429072","phase-3-growth-hormone-replacement-therapy-in-veterans-with-mild-traumatic-brain-injury-mtbi-and-adult-growth-hormone-deficiency-aghd-100429072","NCT04867317","Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)","CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)","GRIT","Inclusion Criteria:\n\n1. OEF\u002FOIF\u002FOND Veteran\n2. Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)\n3. Age 21 - 55 years old\n4. One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey.\n5. GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg\u002FL), or glucagon stimulation test (cut point: 3 mcg\u002FL for BMI up to 25; cut point 1 mcg\u002FL for BMI 25 and above) and IGF-I lab values have to be less than or equal to +1 SDS at baseline\n6. Score of 11 or more on QoL-AGHDA\n7. 4-week stability on any psychotropic medications\n8. 3-month stability on all other hormone treatments\n9. Able and willing to provide informed consent to participate in this study, and complete study protocol.\n\nExclusion Criteria:\n\n1. History of moderate or severe TBI\n2. History of neurologic disorder other than TBI with substantial impact on quality of life\n3. History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder\n4. Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months.\n5. Contraindication to rhGH therapy\n6. Acute medical illness, active infection, cancer or decompensated chronic medical illness\n7. Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed.\n8. Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory and Malingering (TOMM).\n9. BMI \\> 40 or body weight \\> 350 lbs\n10. Pituitary anatomy documented by an MRI using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass)\n11. Women who are pregnant or of child-bearing potential not on contraception\n12. Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses\n13. Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)","21 Years","55 Years",{"count":62,"type":23},172,[64],"PHASE3","The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).",[67,30],"Adult Growth Hormone Deficiency","RECRUITING","2026-06-30",{"date":71,"type":42},"2026-07-02",{"date":73,"type":42},"2025-01-13",{"date":75,"type":23},"2029-09-30",{"name":77,"class":78},"VA Office of Research and Development","FED",17,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":24,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":50},"100619165","multicenter-early-intervention-study-in-adults-with-complaints-after-mild-traumatic-brain-injury-100619165","NCT07341074","Multicenter Early Intervention Study in Adults With Complaints After Mild Traumatic Brain Injury","BRAin INjury REcovery After Symptom-guided Early Therapy","BRAIN-RESET","Inclusion Criteria:\n\n* Age 18-70 years\n* Seen at the ED within 24 hours after trauma\n* Loss of consciousness (\\\u003C30min.)\n* Post-traumatic amnesia (\\\u003C24hrs)\n* Glasgow Coma Scale (GCS) score of 13-15 after initial resuscitation at the ED\n* Comprehension of Dutch language\n\nExclusion Criteria:\n\n* Inability for follow-up\n* Chronic substance abuse (alcohol and\u002For drugs)\n* Severe psychiatric disease\n* Documented previous traumatic brain injury for which the patient was admitted\n* Dementia and\u002For other severe comorbidities\n* Current treatment by physical and\u002For occupational therapist for other indications\n* Language barriers or illiteracy prohibiting understanding and completion of questionnaires","70 Years",{"count":90,"type":23},655,[26],"Rationale: In the Netherlands, traumatic brain injury (TBI) is one of the most frequent neurological diseases and one of the leading causes of disability. Presumably, about half of the total Dutch population will get a TBI during their lifetime. The majority, about 85%, of patients suffers from a mild TBI (mTBI). The incidence of mTBI is estimated at 68,000 patients each year, but this is an underestimation as patients seen at the general practitioner's offices are not taken into account. In general, the prognosis of mTBI is relatively good, however more than 70% of patient still have one or more post-traumatic complaints at six months post-injury influencing resumption of daily (social) activities and return to work\u002Fstudy. Considering the high annual incidence of mTBI the number of patients with incomplete recovery has high social impact accompanied with excessive health care related costs. Post-traumatic complaints in the chronic phase postinjury are considered therapy resistant and so far no evidence based treatment is available. Hence, the most appropriate strategy is to prevent complaints present in the (sub)acute phase after injury to become persistent to improve functional outcome and quality of life.\n\nObjective: The main aim of this study is to improve early care for patients suffering from post-traumatic complaints after mTBI through the development of effective symptom-guided tailored interventions. Nowadays, no effective therapy is available and care-as-usual consists of a wait-and-see policy. Early therapy will reduce posttraumatic complaints and facilitate earlier return to daily activities and work or study, consequently quality of life will be improved as well. This in turn will result in less healthcare consumption and lower societal costs.\n\nStudy design: The investigators propose a prospective three-arm multicenter open randomized controlled trial (RCT), randomizing participants between two interventions and care as usual. The end-point assessment is blinded.\n\nStudy population: Adults, aged 18-70 years, diagnosed with a mTBI at the Emergency Department (ED) of the participating hospitals within 24 hours after injury are eligible for inclusion.\n\nIntervention: At two weeks post-injury the presence, severity, and type of post-traumatic complaints are assessed using the Rivermead Postconcussive complaints Questionnaire (RPQ). If a predefined minimum of complaints is present, a participant is randomised for one of the two interventions or the control group. The first intervention arm consists of symptom-targeted treatment with assignment to physical and\u002For occupational therapy. The second intervention arm involves psychoeducation about the complaints through telephonic counselling. The interventions are offered during three weeks from week 3-6 week post-injury.\n\nMain study parameters\u002Fendpoints: The primary outcome measure is the total RPQ sum score at three months postinjury. The secondary outcome measures are functional outcome and quality of life.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants included in treatment arm 1 will undergo three to six therapy sessions with a physiotherapist and\u002For occupational therapist over a period of three weeks. This regimen may be potentially burdensome by its frequency but the risks associated with these treatments are low. Participants randomised to treatment arm 2 will receive three telephone calls over the course of three weeks, during which psychoeducation will be provided. This intervention is minimally burdensome and risk-free. All participants included in the interventional part of the study will complete questionnaires at three time points after injury and will receive two follow-up telephone calls three and six months post-injury for outcome assessment. This process is minimally burdensome and poses no risk. Finally, participants included in the registry will complete a limited set of questionnaires at three time points, which is also minimally burdensome and riskfree.",[30],"2026-06-23",{"date":96,"type":42},"2026-06-26",{"date":98,"type":42},"2026-02-16",{"date":100,"type":23},"2027-12-31",{"name":102,"class":49},"University Medical Center Groningen",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":24,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100626524","clinical-trial-comparing-the-efficacy-of-two-teletherapy-programs-at-improving-psychological-health-in-people-with-brain-injury-100626524","NCT07436754","Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury","Clinical Trial to Evaluate the Efficacy of Building Emotional Self-awareness Teletherapy (BEST) at Improving Psychological Health in Service Members With Brain Injury","Inclusion Criteria:\n\n* Mild TBI\n* ≥18 years old\n* ≥6 months post-TBI\n* Elevated alexithymia and emotion dysregulation\n* Capacity to consent\n* Speaks and understands English\n* Personal device capable of video conferencing and internet\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* Previous psychiatric hospitalization\n* Visual, hearing, communication, or cognitive impairments that would impede participation\n* Unstable medications (e.g., started \\\u003C 6 weeks prior to enrollment) or anticipated medication changes that will influence mood\u002F affect during study participation\n* Active involvement in an intensive rehabilitation program\n* Individuals who recently started psychotherapy and\u002For mental health counseling (e.g., \\\u003C3 months prior)",{"count":111,"type":23},300,[26],"The purpose of the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) improve their emotional health and well-being. Study participation is completely remote and will last approximately 8 months total, involving 4 assessment visits and 8 sessions of brain training via a secure video-conferencing platform. The 4 assessment visits (about 30-90 minutes each) include surveys and questionnaires about participant's emotional health. These assessment visits will take place before the training, immediately after the training, 3 months after training and 6 months after training. The 8 sessions of 1-on-1 training (about 60-90 minutes each) will be completed over the course of approximately 1 month.",[30,115],"Alexithymia",[117,118,31,119,120],"Emotional dysregulation","Brain training","Veterans","Military service members","2026-06-11",{"date":123,"type":42},"2026-06-12",{"date":125,"type":42},"2026-05-20",{"date":127,"type":23},"2031-03",{"name":129,"class":49},"Hackensack Meridian Health",3,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":24,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100589592","rehabilitation-of-memory-symptoms-after-brain-concussion-100589592","NCT06956417","REhabilitation of MEMory Symptoms After BRain Concussion","REMEMBR","Inclusion Criteria:\n\n1. Age 18-59\n2. Concussion diagnosis confirmed with structured interview based on American Congress of Rehabilitation Medicine diagnostic criteria\n3. Concussion occurred between 6 and 36 months before enrollment\n4. Ongoing memory concerns\n5. Fluent in English\n6. Stable access to a computer, tablet, or smartphone with internet capability\n\nExclusion Criteria:\n\n1. Fail performance validity testing\n2. Comorbid psychiatric or neurological disorder or is taking a medication that could fully account for their memory symptoms","59 Years",{"count":140,"type":23},184,[26],"Persistent memory symptoms after concussion are common, and likely perpetuated by unhelpful illness beliefs and coping behaviors. Results from a pilot study suggested that traditional cognitive rehabilitation and a novel cognitive-behavioral therapy (CBT) protocol were both associated with improvements in subjective memory functioning. The present study will more definitively compare the effectiveness of these interventions for improving subjective memory functioning after concussion.",[144,30],"Concussion, Brain",[146],"Functional cognitive disorder","2026-05-29",{"date":149,"type":42},"2026-06-02",{"date":151,"type":42},"2025-07-02",{"date":153,"type":23},"2029-04-30",{"name":155,"class":49},"University of British Columbia",8,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":18,"minAge":164,"maxAge":20,"enrollmentInfo":165,"targetDuration":4,"studyType":24,"phases":167,"briefSummary":168,"conditions":169,"keywords":173,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":50},"100496221","facilitating-access-to-specialty-treatment-100496221","NCT05741411","Facilitating Access to Specialty Treatment","Utilizing Mobile Health to Expedite Access to Specialty Care for Youth Presenting to the Emergency Department With Concussion at Highest Risk of Developing Persisting Symptoms","Inclusion Criteria for concussed subjects:\n\n* Males and females age 13 - 18\n* Present to the Children's Hospital of Philadelphia (CHOP) Emergency Department (ED) within 72 hours of head injury\n* Meet criteria for concussion as defined by the most recent International Consensus Statement on Concussion\n* Own a smartphone\n* Meet criteria for moderate-to-high risk for Persistent Post-Concussion Symptoms according to 5P rule (score \\>3\u002F12)\n\nExclusion Criteria for concussed subjects:\n\n* Glasgow Coma Scale score \\\u003C13\n* Lower extremity trauma\n* A prior concussion within 1 month\n* Non-English speaking\n* Admission to the hospital at the initial head injury visit\n* Previously enrolled in the study\n* Inability to complete study procedures.\n\nInclusion Criteria for parents:\n\n* Child meets the study eligibility criteria\n\nExclusion Criteria for parents:\n\n* Non-English speaking\n\nInclusion Criteria for providers:\n\n* ED or specialty provider caring for at least one patient via the mobile Health (mHealth)-facilitated care handoff strategy\n\nExclusion Criteria for providers:\n\n* Non-English speaking","13 Years",{"count":166,"type":23},210,[26],"The goal of this hybrid implementation-effectiveness study is to evaluate the effectiveness (hastened recovery times) and feasibility (fidelity in connecting to concussion specialty care) of a novel mobile health intervention, designed to reduce disparities in access to specialty care through the use of remote patient monitoring (RPM) to facilitate care hand-off from the emergency department (ED) to concussion specialty care. Participants will report their symptoms and activity once daily through RPM chat technology that is linked to their electronic health record and prompts referral to specialty care.",[30,170,171,172],"Concussion, Mild","Concussion, Severe","Concussion, Intermediate",[174,175,176,177],"mobile health","emergency department","persistent post-concussion symptoms","remote patient monitoring",{"date":179,"type":42},"2026-05-22",{"date":181,"type":42},"2024-03-11",{"date":183,"type":23},"2027-08-01",{"name":185,"class":49},"Children's Hospital of Philadelphia",{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":192,"sex":18,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":24,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":50},"100596372","non-invasive-stimulation-of-the-glymphatic-system-for-slowing-cognitive-decline-100596372","NCT07044596","Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline","Inclusion Criteria - Healthy Participants :\n\n* Age 20-85 years\n* Willing and able to undergo all procedures\n* Free of any neurological (e.g., epilepsy, stroke, Parkinson's, brain tumors, moderate or severe traumatic brain injury), neuropsychiatric (e.g., schizophrenia, substance abuse, clinical depression), or developmental (e.g., autism, ADHD) or any other medical condition at the discretion of the PI and co-investigators\n\nInclusion Criteria - mTBI :\n\n* Age 20-65\n* Diagnosed with mild traumatic brain injury and be within 1-52 weeks post-injury\n* Willing and able to undergo all procedures\n\nExclusion Criteria - Healthy Participants:\n\n* Contraindication to MRI\n* Known allergies to common electrode materials\n\nExclusion Criteria - mTBI:\n\n* Contraindications for MRI\n* Known allergies to common electrode materials\n* Candidates currently on cardiovascular medications which, in the opinion of the investigators, would introduce a confounding factor to glymphatic system function (i.e. ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers)\n* Candidates who have chronic infectious diseases (e.g. hepatitis, HIV, TB)\n* Candidates diagnosed with small vessel disease, vascular associated dementia (e.g. VCID), or renal disease\n* Candidates retinopathies or neuropathies that, in the opinion of the investigators, would prevent them from being able to complete the study or would introduce a confounding factor to glymphatic system function\n* Candidates with neurological disorders other than those attributed to their primary diagnosis (e.g. MS, PD, ALS, AD or other dementia, uncontrolled pain)\n* Candidates who have had a penetrating injury, craniotomy (with the exception of a burr hole (trephination) for resolution of acute subdural hematoma), or refractory subdural hematoma\n* Candidates with a history of seizures (except those in the acute or post-acute phases and are controlled)\n* Candidates who experienced a loss of consciousness greater than 24 hours as a result of their TBI\n* Candidates who, in the opinion of the investigators, are unable to feel a sensory referred sensation from the stimulation or successfully complete the electrode placement and testing fNIRs",true,"20 Years","85 Years",{"count":196,"type":23},55,[26],"The purpose of this research is to demonstrate that mild stimulation of a nerve (trigeminal nerve) in the head can modulate blood flow in the brain. The modulated blood flow will restore the flow of cerebrospinal fluid (CSF) and this in turn can help improve waste clearance in the brain and prevent build up that may lead to disease.",[30,200],"Post Concussion Syndrome","2026-05-05",{"date":203,"type":42},"2026-05-06",{"date":205,"type":42},"2025-11-13",{"date":207,"type":23},"2026-12",{"name":209,"class":49},"University of Wisconsin, Madison",{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":24,"phases":219,"briefSummary":221,"conditions":222,"keywords":226,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":50},"100473568","phase-2-pathways-relating-amnestic-mci-to-a-mild-traumatic-brain-injury-history-100473568","NCT05446584","Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History","PATH","Inclusion Criteria:\n\n1. Active diagnosis of amnestic mild cognitive impairment\n2. Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample\n3. Female and male subjects\n4. All races\u002Fethnicities\n5. Age 55 years and older\n6. Fluent in English\n\nExclusion Criteria:\n\n1. Mild traumatic brain injury within past year\n2. Lifetime history of moderate or severe brain injury\n3. Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor)\n4. Lifetime major cardiovascular conditions (e.g., heart attack, heart failure)\n5. Current substance use disorder\n6. Current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder)\n7. Current vision or hearing impairment that interferes with testing\n8. Any electronic and or metallic implants in the skull or brain\n9. Current medication use known to alter HD-tDCS reactivity",{"count":218,"type":23},75,[220],"PHASE2","This study will probe if the biological changes in amnestic mild cognitive impairment (aMCI) are related to a history of mild traumatic brain injury (mTBI) using high definition transcranial direct current stimulation (HD-tDCS) and blood-derived biomarker tools. Participants who Do as well as those who Do Not have a history of mTBI will be enrolled in the study.",[223,224,225,30,144],"Mild Cognitive Impairment","Amnestic Mild Cognitive Disorder","Amnestic Mild Cognitive Impairment",[227,228,229,230,231],"MCI","TBI","memory","biomarker","Alzheimer",{"date":203,"type":42},{"date":234,"type":42},"2023-04-20",{"date":236,"type":23},"2027-05-31",{"name":238,"class":49},"University of Texas Southwestern Medical Center",{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":24,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":264,"locationsCount":266},"100348654","neuromodulation-and-neurorehabilitation-for-mtbi-100348654","NCT03819608","Neuromodulation and Neurorehabilitation for mTBI","Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD","Inclusion Criteria:\n\n* At least 18 years of age and no older than 80 years of age\n* 3 months post exposure to mTBI event\n* Have a history of mTBI with PTSD OR mTBI without PTSD as defined by formalized measures to classify mTBI based on the Symptom Attribution and Classification Algorithm (SACA) and the PTSD Module L of the SCID\n* Endorse at least moderate severity on at least one of the four cognitive complaints in the Neurobehavioral Symptom Inventory\n\nExclusion Criteria:\n\n* Participating in another research study\n* Non-fluent in English (speaking and reading)\n* History of epilepsy pre-injury\n* Receiving antiepileptic treatment for documented active seizures in the past 6 months\n* Taking medications that lower seizure threshold including antipsychotics, trazodone and tramadol\n* History of surgery on blood vessels in brain and\u002For valves of the heart\n* History of brain hemorrhage, neurovascular conditions and neurodegenerative disorders\n* History or current diagnosis of psychotic spectrum disorders (i.e. bipolar, schizophrenia)\n* Significant heart disease as determined by physician review of medical chart\n* Pregnant at time of enrollment or any time during study participation\n* MRI or TMS\u002FiTBS contraindications such as claustrophobia, metal in eyes\u002Fface or brain\n* Cardiac pacemakers\u002Fdefibrillators, cochlear implants, nerve stimulators, intracranial metal clips\n* Diagnosis of moderate or severe TBI (loss of consciousness \\> 30 minutes, alteration of consciousness \\> 24 hours, post traumatic amnesia or neuropsychological testing results\n* Prescribed dosage of mental health medications have been altered within the month preceding study screening. Any participant whose mental health medication(s) has\u002Fhave changed, within 30 days of study screening. The following are considered a medication change: the addition of or discontinuation of medication, a change in the dose or dosage (daily amount) of medication.\n* Taking prescribed CNS stimulants and choosing to not stop these medications during study participation\n* Taking prescribed CNS stimulants and choosing to not stop these medications during study participation\n* Testing positive for opiates and do not have a prescription for opiates. If on prescription opiates and taking more than the equivalent of 200 mg of morphine per day.\n* Questionably valid test performance as indicated by a score of ≤ 85% on the Immediate Recognition, Delayed Recognition or Consistency Scales of the Medical Symptom Validity Test (MSVT) and clinical determination of questionable performance validity by a neuropsychologist on the research team\n* Actively suicidal as evidenced by plan to harm or recent attempt communicated on the Structured Clinical Interview for DSM-V (SCID-5).\n* Increased Intracranial Pressure (ICP) as evidenced through a funduscopic evaluation or on the baseline MRI scan.\n* Moderate or severe cannabis use disorder defined by ≥ 4 symptoms on the SCID-5\n* Severe alcohol use disorder defined by ≥ 6 symptoms on the SCID-5\n* Baseline systolic BP greater or equal to 170","80 Years",{"count":248,"type":23},200,[26],"This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +\u002F- PTSD.",[30,252],"Post Traumatic Stress Disorder",[254,255,256,257,258],"mTBI","PTSD","intermittent theta burst stimulation","cognitive training","neuroimaging",{"date":260,"type":42},"2026-05-08",{"date":262,"type":42},"2021-04-01",{"date":207,"type":23},{"name":265,"class":49},"Northwestern University",2,{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":18,"minAge":273,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":276,"phases":4,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":50},"100636720","recovery-among-older-adults-following-mild-tbi-100636720","NCT07569354","Recovery Among Older Adults Following Mild TBI","Inclusion Criteria\n\n* Aged 65 years or older\n* Treated for mild TBI (defined below) at the R Adams Cowley Shock Trauma Center (STC) or at one of six University of Maryland Affiliated Hospitals within 72 hours of injury\n* Mild TBI was defined as:\n\n  * Traumatically induced physiological disruption of brain function, as manifested by at least one of the following 1) loss of consciousness ≤30 minutes, post-traumatic amnesia \\\u003C24 hours, observed or self-reported transient confusion, disorientation, or impaired consciousness, or neurologic deficit as defined by a Glasgow Coma Scale (GCS) score of 13-14 on admission.\n  * GCS of 15 with no other evidence of mild TBI was also accepted with positive computed tomography image.\n\nExclusion criteria\n\n* Injury to any other body region resulting in an abbreviated injury scale (AIS) score \\>2\n* Anticipation that patient would not be ambulatory at 2-weeks post-injury\n* History of dementia as determined by patient\u002Fproxy report or medical history\n* Non-ambulatory pre-injury\n* No available proxy\n* Not English speaking\n* Prisoners\n* Live \\>55 miles from the STC.","65 Years",{"count":275,"type":23},250,"OBSERVATIONAL","Among fall related injuries in older adults, head injuries are the most common, yet almost nothing is known about recovery from head injury, also known as traumatic brain injury or TBI, in this population. The RETRO-TBI study is a prospective cohort study of 250 adults aged 65 and older with mild TBI to evaluate recovery in cognitive, physical and psychological function and sleep quality at four timepoints (2 weeks and 3, 6, and 12 months) over the year following injury and identify factors associated with recovery trajectories. The potential impact of this work is that it will generate new knowledge that will guide targeted treatment efforts and inform future development of strategies to optimize recovery following this common fall-related injury among older adults.",[30],[228,280],"Older adults","2026-04-28",{"date":203,"type":42},{"date":284,"type":42},"2023-05-11",{"date":286,"type":23},"2028-12-31",{"name":288,"class":49},"University of Maryland, Baltimore",{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":24,"phases":299,"briefSummary":300,"conditions":301,"keywords":305,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":50},"100622552","evaluation-of-cognitive-behavioral-therapy-for-insomnia-cbt-i-in-individuals-with-mild-traumatic-brain-injury-mtbi-100622552","NCT07385105","Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)","Exploring Cognitive Behavioral Therapy for Insomnia (CBT-I) in Mild Traumatic Brain Injury (mTBI)","Inclusion Criteria:\n\n* A history of mTBI documented by a physician and sleep problems for more than 4 weeks\n* A score ≥ 10 on the Insomnia Severity Index (ISI)\n* Speak, read, and write English\n\nExclusion Criteria:\n\n* History of other neurological or psychological conditions\n* Patient Health Questionnaire-9 (PHQ-9) score higher than 20 (severe depressive symptoms)\n* Generalized Anxiety Disorder-7 (GAD-7) score higher than 15 (severe anxiety symptoms)\n* Montreal Cognitive Assessment (MoCA) score less than 24","60 Years",{"count":298,"type":23},15,[26],"This study will employ cognitive behavioral therapy for insomnia (CBT-I) among individuals with mild traumatic brain injury (mTBI) who experience sleep disturbances. The research aims to evaluate the effects of CBT-I on sleep, mTBI symptoms, and, in particular, the ability of individuals with mTBI to engage in their desired daily life activities. The main questions this study aims to answer are:\n\n1. Does CBT-I positively impact symptoms of mTBI?\n2. Does CBT-I improve functional performance in individuals with mTBI?",[302,30,303,304],"Sleep Architecture","Sleep","Sleep and Circadian Problems",[306,307,308,34,254,309],"Sleep problems","Cognitive behavioral Therapy for insomnia","CBT-I","Functional performance","2026-04-27",{"date":312,"type":42},"2026-05-01",{"date":314,"type":42},"2026-03-01",{"date":316,"type":23},"2027-01-01",{"name":318,"class":49},"University of Missouri-Columbia",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":273,"enrollmentInfo":325,"targetDuration":4,"studyType":24,"phases":326,"briefSummary":327,"conditions":328,"keywords":330,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":50},"100491711","combined-neuromodulation-and-cognitive-training-for-post-mtbi-depression-100491711","NCT05682677","Combined Neuromodulation and Cognitive Training for Post-mTBI Depression","Inclusion Criteria:\n\n1. Male or female\n2. All racial and ethnic groups\n3. Ages 18 to 65\n4. Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health\n5. History of mild TBI (as defined by the DoD\u002FVA criteria used in conjunction with the OSU TBI-ID method) over 3 months prior to study entry\n6. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI\n7. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms\n8. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period\n9. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)\n10. No contraindications to MRI (passes MRI safety screening questionnaire)\n11. Able to commit to the treatment schedule\n12. Able to complete assessment procedures in English\n13. Intact decision-making capacity and ability to provide voluntary informed consent\n\nExclusion Criteria:\n\n1. History of moderate, severe, or penetrating TBI\n2. History of other neurological condition unrelated to TBI, including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy\n3. Implanted medical devices including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed\n4. Active manic or psychotic illness per MINI\n5. Current substance use disorder per MINI\n6. Current active suicidal or homicidal ideation\n7. Pregnant or intending to become pregnant within the study period; breastfeeding\n8. Other sensory conditions or illnesses precluding participation in assessments or treatment\n9. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy\n10. Taking medication that lowers seizure threshold\n11. Previous failed treatment with rTMS, iTBS, or ECT\n12. Completed \\>4 sessions of cognitive rehabilitation within the last 3 years",{"count":22,"type":23},[26],"The primary goal of this clinical trial is to evaluate whether Personalized Augmented Cognitive Training (PACT) plus intermittent theta burst stimulation (iTBS) is effective for treating depression in Service Members, Veterans, and civilians who have sustained a mild TBI. Participants will receive PACT plus 20 sessions of iTBS or sham iTBS over 4 weeks. Assessments will occur at baseline, 2 weeks, 4 weeks, and 8 weeks. Researchers will compare the PACT+iTBS group to the PACT+sham iTBS group to see if PACT+iTBS is associated with more depression improvement.",[329,30,144],"Depression",[331,332,333,334,335,336,337,338,257,339],"brain stimulation","neuromodulation","transcranial magnetic stimulation","theta burst stimulation","TMS","TBS","rTMS","iTBS","cognitive rehabilitation",{"date":312,"type":42},{"date":342,"type":42},"2023-09-19",{"date":344,"type":23},"2027-06-30",{"name":346,"class":49},"University of California, San Diego",{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":60,"enrollmentInfo":355,"targetDuration":4,"studyType":24,"phases":357,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":130},"100472060","rtms-for-military-tbi-related-depression-100472060","NCT05426967","rTMS for Military TBI-related Depression","ADEPT: Adaptive Trial for the Treatment of Depressive Symptoms Associated With Concussion Using Repetitive Transcranial Magnetic Stimulation Protocols","ADEPT","Inclusion Criteria:\n\n* Age 18-55 at the time of consent. Older individuals will not be enrolled in this initial trial for reasons of safety and expected reduced efficacy.\n* Current or former US military service member eligible for care at a Military Treatment Facility (MTF) or Veterans Administration Medical Center (VAMC.)\n* Able to provide written, informed consent in English .\n* Self-reported or medically diagnosed history of concussion (synonymous with \"mild TBI.\") \\>6 months, but \\\u003C26 years prior to consent, defined based on the DoD\u002FVA definition:\n\n  1. Positive Loss of Consciousness of \\\u003C30 minutes as confirmed by the TBI Screener and\u002For medical records and\u002For;\n  2. Positive Alteration of Consciousness of \\\u003C24 hours as confirmed by the TBI Screener and\u002For medical records and\u002For;\n  3. Positive Post-traumatic Amnesia of 0 to 1 day as confirmed by the TBI Screener and\u002For medical records.\n\n     * Note: Neuroimaging data or documentation from medical records is not required.\n* Baseline MADRS \\>13 at the time of screening indicating at least mild-moderate depressive symptoms.\n* Maintained a steady psychotropic medication regimen for six weeks and a steady behavioral therapy regimen for twelve weeks prior to enrollment in the study.\n* Female participants with child-bearing potential must agree to use an effective method of birth control during the course of the study.\n* Under the care of a primary care and\u002For behavioral health provider.\n\nExclusion Criteria:\n\n* Elevated risk of seizures at the time of rTMS including any of the following:\n\n  1. History of unprovoked seizures.\n  2. History of seizure within 24 hours of sustaining a concussion(s) or other head injury regardless of whether it was determined to have been related to concussion.\n  3. Family history of two or more unprovoked seizures in a first degree relative (parent, sibling, or child).\n  4. History of Moderate, Severe, or Penetrating TBI based on TBI Screener and\u002For medical records.\n  5. Intracranial lesion (such as intracranial tumor or intraparenchymal hemorrhage) that, in the opinion of the investigators, would increase seizure risk.\n  6. Currently taking medication or other substances (such as tricyclic antidepressants or neuroleptics) that, in the opinion of the investigator, lowers the seizure threshold.\n* Contraindications to awake 3T MRI without contrast at the time of the Baseline MRI according to site radiology department criteria.\n* Severe claustrophobia interfering with medication\u002Fsedation-free 3T closed-bore MRI.\n* Intracranial lesion that would produce an artifact that would compromise the integrity of rsfMRI data.\n* History of severe or recent uncontrolled heart disease.\n* Presence of a cardiac pacemaker or intracardiac lines.\n* Any implant, prosthesis or other permanent alteration of the body (such as implanted neurostimulators and medication pumps) that, in the opinion of the investigator, would be unsafe with MRI or TMS or that would produce an artifact that would compromise the integrity of data.\n* Presence of rapidly progressive illnesses such as late-stage cancer, neurodegenerative conditions, major organ failure, etc.\n* History of Bipolar Disorder or Schizophrenia Spectrum Disorders.\n* Current evidence of substance-induced mood disorder, active psychosis, or depression secondary to general medical illness other than TBI.\n* Severe or uncontrolled substance use.\n* Concomitant or lifetime history of receiving open-label TMS, due to issues preserving blinding.\n* Concomitant or recent history (within 12 weeks prior to enrollment) of receiving other neurostimulatory treatment, including but not limited to transcranial direct current (tDCS), transcranial alternating current (tACS), alpha stim, or electroconvulsive therapy.\n* Suicide attempt within six months prior to enrollment.\n* Right upper extremity amputation or other condition precluding left motor threshold calibration.\n* Unable to complete timeline of study (e.g., planned hospitalization partway through the study period.)\n* Prisoner, or other legally restricted freedom of movement and participation.\n* Any other considerations that, in the opinion of the investigators, may adversely affect participant safety, participation, or the scientific validity of the data being collected (e.g., erratic or unreliable responses, inconsistent communication, inability to remain on a steady neurotropic medication and\u002For behavioral therapy regimen over the course of the Randomization phase of the study.)",{"count":356,"type":23},198,[26],"The purpose of this study is to investigate the efficacy, safety, and tolerability of two dorsolateral prefrontal cortex (DLPFC) repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in United States (U.S.) military service members and veterans with a history of concussion\u002Fmild traumatic brain injury (TBI).",[360,30,31],"Depressive Symptoms",[362,360,31,363,364],"Transcranial Magnetic Stimulation (TMS)","Mild Traumatic Brain Injury (TBI)","Functional Magnetic Resonance Imaging (fMRI)","2026-04-24",{"date":367,"type":42},"2026-04-29",{"date":369,"type":42},"2024-12-16",{"date":371,"type":23},"2026-12-31",{"name":373,"class":49},"Henry M. Jackson Foundation for the Advancement of Military Medicine",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":24,"phases":383,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":266},"100597218","improving-cognitive-rehabilitation-outcomes-100597218","NCT07055633","Improving Cognitive Rehabilitation Outcomes","Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD","Inclusion Criteria:\n\n* Post 9\u002F11 Veterans enrolled at VA San Diego or VA Portland\n* Ability to provide informed consent\n* Living independently\n* History of mTBI confirmed by OSU-TBI\n* Current diagnosis of PTSD confirmed by CAPS-5\n* Current cognitive concerns (\"Do you have concerns about your cognition, thinking, attention, or memory?\")\n* Current concern regarding depression and\u002For sleep disturbance; defined by a score of 5 on the PHQ-9 and\u002For 8 on the ISI, respectively (score of 2 or higher on ISI item 1, 2, or 3, reflecting at least \"moderate\" difficulty with falling asleep, staying asleep, or waking up too early in the morning)\n\nExclusion Criteria:\n\n* Current substance use disorder with \\\u003C30 days abstinence\n* History of primary psychotic disorder\n* History of moderate to severe TBI (loss of consciousness \\>30 minutes)\n* History of macular degeneration or bipolar disorder (both contraindicated for bright light therapy)\n* Not work night or swing shift schedules\n* Untreated obstructive sleep apnea either via self-report or a score 5 on the STOP-BANG\n* Current engagement in bright light therapy\n* Auditory or visual impairments precluding participation in assessments or treatments",{"count":382,"type":23},144,[26],"Posttraumatic stress disorder (PTSD) and mild TBI (mTBI) frequently co-occur in post-9\u002F11 Veterans, and together are associated with worse cognitive performance, mental health, everyday functioning, community integration, quality of life, and treatment response than either condition alone. Additional comorbidities, such as depression and sleep disturbance, are common and further exacerbate these problems. The investigators will investigate Compensatory Cognitive Training (CCT) and Morning Bright Light Therapy (MBLT) vs Negative Ion Generator (ION), to directly target cognition, depression, and sleep disturbance and to improve CCT-associated rehabilitation outcomes. The investigator's randomized controlled trial in 144 Veterans with mTBI+PTSD across two VA sites will compare cognition, functioning, and other secondary outcomes following CCT+MBLT vs. CCT+ION. This study addresses the significant gap in services and evidence-based treatments for Veterans with mTBI+PTSD.",[30,386],"Posttraumatic Stress Disorder",[388,389],"brain injury","posttraumatic stress disorder","2026-04-22",{"date":365,"type":42},{"date":393,"type":42},"2026-04-01",{"date":395,"type":23},"2030-09-30",{"name":77,"class":78},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":18,"minAge":404,"maxAge":273,"enrollmentInfo":405,"targetDuration":4,"studyType":24,"phases":406,"briefSummary":408,"conditions":409,"keywords":412,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":50},"100488971","phase-1-frontal-itbs-for-impulsivity-and-suicidal-ideation-in-veterans-with-mild-traumatic-brain-injury-100488971","NCT05647044","Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury","Neuromodulation for Impulsivity and Suicidality in Veterans With Mild Traumatic Brain Injury and Common Co-occurring Mental Health Conditions","Inclusion Criteria:\n\n* 22-65 years of age\n* can read and speak English\n* meets criteria for mTBI according to the symptom attribution and classification (SACA) scale\n* Has a C-SSRS (suicidal ideation rating) of \\>1 within the past month\n* Has a history of impulsivity documented in the medical chart and\u002For a score of \\>20 on the UPPS-P negative urgency impulsivity subscale\n\nExclusion Criteria:\n\n* Has contraindications to iTBS (i.e., epilepsy)\n* Has contraindications to MRI (i.e., claustrophobia, ferromagnetic metal implants)\n* Has an active substance use disorder per the DSM-V criteria\n* Has a history of moderate to severe TBI\n* Has a history of non-traumatic neuroinjury (i.e., stroke, neurosurgery, hemorrhage)\n* Has a history of, or current psychosis not due to an external cause\n* Is pregnant\n* Has an active, unstable medical condition\n* Is within 12 weeks of a major surgery or operation\n* Is within 1 year of TBI","22 Years",{"count":196,"type":23},[407],"PHASE1","The investigators hope to develop a treatment for suicidal ideation (SI), impulsivity and functional impairments (such as difficulties in social and work settings) that occur after a mild traumatic brain injury (mTBI). These conditions have been shown to be linked. The investigators are using a high-powered magnetic pulse, called intermittent theta burst stimulation (iTBS) applied to the head to see if it can improve these symptoms. The high-powered magnetic pulse causes certain cells in the brain to activate, which seems to strengthen connections between parts of the brain. The purpose of this research is to gather early information on the safety and effectiveness of iTBS provided to the front of the head for impulsivity, SI and functional deficits after mTBI. The investigators plan to use the data collected in this study to develop larger studies in the future. iTBS is FDA approved, but not for these specific symptoms, or in the specific location the investigators are placing it. The investigators are testing to see if its effective for the above conditions when applied to the front of the head.",[30,410,411],"Suicidal Ideation","Impulsivity",[413,414,415,416,417,418,419,420,421,422,423,424],"brain concussion","brain injuries, traumatic","brain injuries","self-injurious behavior","suicide, attempted","suicide","impulsive behavior","risk-taking","brain diseases","craniocerebral trauma","social problems","mental disorders","2026-04-09",{"date":427,"type":42},"2026-04-14",{"date":429,"type":42},"2024-05-20",{"date":431,"type":23},"2028-03-31",{"name":77,"class":78},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":24,"phases":443,"briefSummary":444,"conditions":445,"keywords":448,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":50},"100630649","tes-ht100-clinical-validation-for-brain-injury-screening-in-patients-with-mild-head-trauma-or-neurological-symptoms-100630649","NCT07490418","TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms","TES HT100 Clinical Outcomes - Clinical Validation of the TES HT100 Temnograph for Brain Injury Screening in Patients With Mild Head Trauma or Suspected Neurological Symptoms (TESCO)","TESCO","Inclusion Criteria:\n\n* Age greater than 18 years\n* Provision of informed consent\n* Presentation to the Emergency Department with mild head injury, or\n* Presentation to the Emergency Department for non-traumatic neurological symptoms and not in a critical condition, including:\n* syncope\n* spatial disorientation and\u002For loss of balance\n* speech disturbance and\u002For facial hemi-paresis\n* visual alterations\n* memory loss and\u002For confusional state\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Pregnant women\n* Metal plates or metal prostheses installed in the skull cap\n* Severe head trauma and\u002For extensive lacerated-contused areas\n* Critical condition\n* Visible skull fracture\n* Failure or inability to provide signed informed consent",{"count":442,"type":23},850,[26],"The goal of this clinical study is to evaluate how accurately and safely the TES HT100 device can identify intracranial abnormalities in adult emergency department patients with mild head trauma or neurological symptoms that are not related to trauma and are not immediately life-threatening. The main questions it aims to answer are:\n\n* How well does TES HT100 identify patients with intracranial abnormalities compared with head CT, the reference standard?\n* Is TES HT100 safe to use in this patient population?\n* Could TES HT100 help improve patient triage and use of hospital resources in the emergency setting?\n\nResearchers will compare the result of TES HT100 with the head CT report.\n\nParticipants will:\n\n* Be enrolled if they are adults presenting to the emergency department with mild head trauma or selected neurological symptoms\n* Undergo standard clinical assessment and head CT according to usual care\n* Have an additional TES HT100 examination lasting about 5 minutes, performed by trained personnel\n* Be assessed for device performance and any adverse events related to use of the device",[30,446,447],"Intracranial Lesions","Neurological Symptoms Not Related to Head Trauma",[449,450,451,452,453,454],"Head Trauma","Temnography","TES","Brain Injury","Brain lesion","Emergency Department","2026-03-18",{"date":457,"type":42},"2026-03-24",{"date":459,"type":42},"2024-12-04",{"date":461,"type":23},"2026-07",{"name":463,"class":464},"B&B srl","INDUSTRY",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":192,"sex":18,"minAge":471,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":24,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":483,"leadSponsor":485,"locationsCount":4},"100582538","evaluating-huddles-as-a-novel-approach-to-improving-concussion-safety-100582538","NCT06864611","Evaluating Huddles as a Novel Approach to Improving Concussion Safety","Inclusion Criteria:\n\n* Children between the ages of 9 and 13 on eligible teams in participating leagues.\n* Soccer coaches of children between the ages of 9 and 13 on eligible teams in participating leagues.\n* Read and write English\n\nExclusion Criteria:\n\n* Cannot read and write English","9 Years",{"count":473,"type":23},2000,[26],"Investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of Pre-Game Safety Huddles (Huddles) in youth soccer.",[30],[33,388,478],"prevention","2026-03-17",{"date":481,"type":42},"2026-03-20",{"date":44,"type":23},{"date":484,"type":23},"2030-04-30",{"name":486,"class":49},"Seattle Children's Hospital",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":273,"enrollmentInfo":494,"targetDuration":4,"studyType":24,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":50},"100611931","targeting-neuroplasticity-for-persistent-post-concussive-cognitive-symptoms-100611931","NCT07246993","Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms","Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms: A Trial of tDCS and Cognitive Training 3-12 Months Post-mTBI","Inclusion Criteria:\n\n* Age 18-65\n* Has sustained a single mTBI 3-12 months prior to enrollment\n* Meets criteria for PPCS (assessed using the CP Screen)\n* Has reliable access to a smartphone\n\nExclusion Criteria:\n\n* Inability to provide informed consent or complete study procedures\n* History of moderate\u002Fsevere TBI\n* Significant neurological or psychiatric disorders (other than PPCS-related symptoms like mild depression\u002Fanxiety)\n* Substance dependence within the last six months\n* Contraindications to tDCS (e.g., implanted metal, skin lesions on scalp)",{"count":495,"type":23},30,[26],"This project investigates an innovative combination of non-invasive neuromodulation (transcranial direct current stimulation - tDCS) and cognitive training as a novel treatment approach aimed at improving function in individuals suffering from persistent post-concussive syndrome (PPCS) following mild traumatic brain injury (mTBI).",[499,30],"Persistent Post Concussion Syndrome","2026-03-16",{"date":479,"type":42},{"date":503,"type":42},"2026-03-05",{"date":505,"type":23},"2028-01-01",{"name":507,"class":49},"University of Minnesota",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":273,"enrollmentInfo":515,"targetDuration":4,"studyType":24,"phases":516,"briefSummary":517,"conditions":518,"keywords":528,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":50},"100521768","phase-2-personalized-brain-stimulation-to-treat-chronic-concussive-symptoms-100521768","NCT06073886","Personalized Brain Stimulation to Treat Chronic Concussive Symptoms","Personalized Circuit-Based Frontoamygdala Neuromodulation for Persistent Post-Concussive Symptoms","Inclusion Criteria:\n\n* Mild traumatic brain injury (mTBI) defined in accord with the World Health Organization criteria in the last 12 months\n* age 18-65 at the time of the mTBI\n* high burden of post-concussive symptoms defined as a score \\>=20 on the Rivermead Post-Concussion Symptoms Questionnaire\n\nExclusion Criteria:\n\n* objective neurologic deficits\n* ongoing or prolonged (\\>3 months) post-concussive symptoms from a prior mTBI within 2 years of the index injury\n* history of transcranial magnetic stimulation (TMS) therapy\n* contraindications for TMS or magnetic resonance imaging (MRI) (e.g., metallic implant other than dental, pacemaker)\n* severe mental, physical, or medical problems that would impede participation or pose a risk for the planned intervention (e.g., liver, kidney, or heart disease, uncontrolled diabetes or hypertension, malignancy, psychosis, previous seizure, pregnancy)\n* active alcohol or illicit drug abuse\n* inability to speak and read English",{"count":218,"type":23},[220],"The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS).\n\nThe investigators intend to answer the questions:\n\n1. Does personalized TMS improve brain connectivity after concussion?\n2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms?\n3. Do the improvements last up to 2 months post-treatment?\n4. Are there predictors of treatment response, or who might respond the best?\n\nParticipants will undergo 14 total visits to University of California Los Angeles (UCLA):\n\n1. One for the baseline symptom assessments and magnetic resonance imaging (MRI)\n2. Ten for TMS administration\n3. Three for post-treatment symptom assessments and MRIs\n\nParticipants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.",[519,144,30,520,521,522,523,524,525,526,329,527],"Post-Concussion Syndrome","Head Injury","Headache","Dizziness","Cognitive Symptom","Dysautonomia","Anxiety","Irritability; Syndrome","Post-traumatic Stress Disorder",[529,530,531,532,533,534],"Transcranial Magnetic Stimulation","Magnetic Resonance Imaging","Functional MRI","Personalized neuromodulation","Amygdala","Prefrontal Cortex","2026-02-21",{"date":537,"type":42},"2026-02-24",{"date":539,"type":42},"2024-03-06",{"date":541,"type":23},"2027-01",{"name":543,"class":49},"University of California, Los Angeles",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":192,"sex":18,"minAge":552,"maxAge":553,"enrollmentInfo":554,"targetDuration":4,"studyType":24,"phases":556,"briefSummary":557,"conditions":558,"keywords":561,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":50},"100497865","neuromodulation-and-neuroimaging-in-older-children-with-mild-traumatic-brain-injury-100497865","NCT05762796","Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury","Assessing the Efficacy of Alterations in Subcortical-Cortical Functional Connectivity From Transcranial Direct Current Stimulation in Older Children After Mild Traumatic Brain Injury","CI-tDCS","Experimental Cohort:\n\nInclusion Criteria:\n\n* age 10-15 years at enrollment\n* enrolled after 6 weeks of mTBI injury\n* exhibiting post-concussive symptoms (e.g., difficulty planning, sequencing, and executing a motor action)\n* Sustained an mTBI or concussion within the past 12 months\n* Parent and child proficient in English\n\nHealthy Controls Cohort:\n\nInclusion Criteria:\n\n* 10 to 15 years old\n* no concussion history\n* Parent and child proficient in English\n\nExperimental Cohort:\n\nExclusion Criteria:\n\n* loss of consciousness \\> 30 minutes\n* post-traumatic amnesia \\> 24 hours\n* intracranial findings on clinical imaging\n* history of developmental delay\n* history of learning disability or ADHD\n* Sustained a lower limb or upper limb injury that has not healed\n* History of Seizures\n* Noticeable skin lesions\u002Fburns or any other severe skin problems at the site of the electrodes before the start of the stimulation.\n* Parent\u002Fguardian report metal implants anywhere in the head\u002Fncek\u002Fbody on the MRI screening form (see attached).\n* Parent\u002Fguardian report shrapnel\u002Fbullets in the body on the MRI screening form.\n* Parent\u002Fguardian report any electronic implant such as a cardiac pacemaker, cochlear implant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, any implant held in place with a magnet, heart valve, or deep brain stimulator on the MRI screening form.\n* Parent\u002Fguardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.\n* Parent\u002Fguardian report being claustrophobic on the MRI screening form.\n* Parent\u002Fguardian report and provide orbit x-ray after the eye injury involving a metal that the subject is cleared as indicated on the MRI screening form.\n* Pregnant females as reported by parent\u002Fguardian on the pre-consent screening form. Pubertal\u002Fpost-pubertal female participants14 and above will be provided a separate post-consent screening form at each MRI visit to ensure the female reports accurately without fear.\n\nHealthy Controls Cohort:\n\nExclusion Criteria:\n\n* diagnosed with developmental delay\n* sustained a lower limb or upper limb injury that has not healed\n* history of Learning Disability and\u002For ADHD\n* Parent\u002Fguardian report metal implants anywhere in the head\u002Fncek\u002Fbody on the MRI screening form (see attached).\n* Parent\u002Fguardian report shrapnel\u002Fbullets in the body on the MRI screening form.\n* Parent\u002Fguardian report any electronic implant such as a cardiac pacemaker, cochlear implant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, any implant held in place with a magnet, heart valve, or deep brain stimulator on the MRI screening form.\n* Parent\u002Fguardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.\n* Parent\u002Fguardian report being claustrophobic on the MRI screening form.\n* Parent\u002Fguardian report and provide orbit x-ray after the eye injury involving a metal that the subject is cleared as indicated on the MRI screening form.\n* Pregnant females as reported by parent\u002Fguardian on the pre-consent screening form. Post-pubertal females 14 and above will be provided a separate post-consent screening form at each MRI visit to ensure the female reports accurately without fear.","10 Years","15 Years",{"count":555,"type":23},10,[26],"Mild traumatic brain injury (mTBI) often causes persistent motor and cognitive deficits in children resulting in functional limitations. We are testing a brain stimulation method along with evaluating objective tools to help record and restore communication among affected brain areas, which will facilitate recovery in youth after mTBI.",[29,30,559,560],"Motor Disorders","Cognitive Impairment",[29,30,562,563,560,564,565],"Child","Motor Activity","Transcranial Direct Current Stimulation","Neuroimaging","2026-02-02",{"date":568,"type":42},"2026-02-03",{"date":570,"type":42},"2024-02-20",{"date":572,"type":23},"2027-06",{"name":574,"class":49},"State University of New York at Buffalo",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":192,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":24,"phases":584,"briefSummary":585,"conditions":586,"keywords":587,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":596,"locationsCount":50},"100620326","passive-neurosensory-reintegration-training-as-a-tool-to-augment-mild-traumatic-brain-injury-100620326","NCT07356167","Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury","PNRT for mTBI","Inclusion Criteria:\n\n1. Adults aged 18 or older\n2. Clear mechanism of injury (i.e., direct or indirect impact to head), or Any individual presenting with complaints of sudden (\\\u003C24h) onset neurosensory symptoms as characterized by hearing a noise, feeling a force, or having an unexpected neurosensory perception and unexplained by any other known etiology (\"sudden neurosensory events\" or SNEs)\n3. Glasgow Coma Scale (GCS) score of 13-15 at the time of injury\n4. Observed or reported focal signs at the time of injury (e.g., loss of consciousness, amnesia, or confusion) or neurosensory symptoms (e.g., dizziness, headaches, photo\u002Fphonophobia, fatigue, vision problems, sleep changes, mood changes, cognitive fog) lasting over 4 weeks to 3 months (sub-acute), or over 3 months (chronic) following brain injury\n\nExclusion Criteria:\n\n1. Any of the following: moderate to severe TBI characterized by penetrating head trauma, GCS \\\u003C13 at the time of injury, LOC \\>30 minutes or PTA \\>24 hours, subdural or epidural hemorrhage for most recent occurence\n2. mTBI\u002FSNE Group: History of 4 or more clinically diagnosed mTBIs that warranted emergent assessment in a hospital or emergency department setting Control Group: History of mTBI within the last 12 months or presence of mTBI-related symptoms at time of enrollment\n3. Presence of severe aphasia\n4. History of diagnosed psychiatric disorder or autoimmune\u002Frheumatologic conditions prior to brain injury\n\n   1. Uncontrolled autoimmune\u002Frheumatologic conditions including but not limited to Lyme, POTS, EDS, long COVID\n   2. Psychiatric disorders: including but not limited to severe depression, schizophrenia, lupus)\n5. Documented neurological disorders (e.g., epilepsy, stroke, dementia)\n6. Legally blind (characterized by a best-corrected visual acuity of 20\u002F200 or less in the better eye or a visual field of 20 degrees or less)\n7. History of tumor of the brain or central nervous system\n8. Actively receiving vision therapy for current mTBI-related visual-impairment\n9. Wards of the state or prisoners",{"count":583,"type":23},80,[26],"Mild traumatic brain injury (mTBI) poses a substantial clinical and public health burden, often leading to persistent neurosensory and cognitive symptoms for which diagnostic and therapeutic solutions remain limited. This study proposes a multimodal diagnostic framework that integrates established mTBI screening tools and clinical neuro-optometric assessments with high-resolution oculomotor, vestibular, and reaction time (OVRT) testing to enhance diagnostic precision and identify prognostic markers of recovery. Normative data will be established in healthy controls to inform objective thresholds and support clinical implementation. Concurrently, we will evaluate the safety, tolerability, and preliminary efficacy of a novel, minimal-risk multisensory therapeutic intervention (i.e., passive neurosensory reintegration training, or PNRT) for individuals with sub-acute or chronic mTBI. By addressing critical gaps in both diagnosis and treatment, this project will improve mTBI recovery outcomes, inform future clinical trials, and advance evidence-based mTBI care guidelines.",[30],[254,34,228,588,589],"visuo-vestibular dysfunction","vestibular dysfunction","2026-01-12",{"date":592,"type":42},"2026-01-21",{"date":594,"type":42},"2025-12-15",{"date":236,"type":23},{"name":597,"class":49},"University of Miami",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":605,"enrollmentInfo":606,"targetDuration":4,"studyType":24,"phases":608,"briefSummary":609,"conditions":610,"keywords":612,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":50},"100558505","behavioral-insomnia-treatment-in-mild-traumatic-brain-injury-100558505","NCT06551987","Behavioral Insomnia Treatment in Mild Traumatic Brain Injury","Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury","Inclusion Criteria:\n\n* Active duty U.S. military service members.\n* At least 18 years of age.\n* Ability to provide informed consent and follow study-related instructions.\n* Self-report of a Mild Traumatic Brain Injury (mTBI) at least 3 months prior to enrollment based on self-report.\n* At least 2 postconcussive symptoms scored \\> 2 (moderate) on the Neurobehavioral Symptom Inventory (NSI), with at least 1 of these symptoms from the cognitive domain in addition to the sleep disturbances item.\n* Clinically significant chronic insomnia disorder assessed by an independent evaluator using the Structured Clinical Interview for Sleep Disorders-Revised (SCISD-R)\\_No Split Week Self-Assessment of Sleep Survey (SASS-Y).\n* Minimum score of 15 on the Insomnia Severity Index (ISI).\n* Plans to be in the area for the next 3 months.\n* Stable on psychotropic and hypnotic medications for at least 1 month.\n* Stable on continuous positive airway pressure therapy if diagnosed with sleep apnea for at least 1 month.\n\nExclusion Criteria:\n\n* Moderate TBI (e.g., skull fracture, brain hemorrhage, hematoma) indicated by self-report or medical record.\n* Any sleep, medical, or psychiatric disorder requiring urgent treatment (e.g., suicide risk, substance use, insomnia with occupational impairment in high risk professions; very short sleep duration of less than 4 hours on average; bipolar disorder or psychosis) or that otherwise interferes with the completion of the baseline assessment.\n* Working night shifts (i.e., duty later than 9:00 pm or before 5:30 am) more than 3 times per month.\n* Planned major surgery.\n* Pregnancy, assessed by self-report and review of medical record.","45 Years",{"count":607,"type":23},160,[26],"This is a single site, two-armed random controlled trials (RCT) comparing six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).",[611,30],"Insomnia",[613,614,611,30,615],"Cognitive Behavioral Therapy for Insomnia","Brief Behavioral Therapy for Insomnia","Active Duty Military Personnel","2026-01-06",{"date":618,"type":42},"2026-01-07",{"date":620,"type":42},"2024-12-03",{"date":622,"type":23},"2027-09-01",{"name":624,"class":49},"The University of Texas Health Science Center at San Antonio",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":192,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":24,"phases":634,"briefSummary":635,"conditions":636,"keywords":641,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":653,"leadSponsor":655,"locationsCount":50},"100618126","crisis-response-planning-in-military-personnel-with-mild-traumatic-brain-injury-100618126","NCT07327567","Crisis Response Planning in Military Personnel With Mild Traumatic Brain Injury","A Randomized Clinical Trial Utilizing Crisis Response Planning in Military Personnel With Mild Traumatic Brain Injury","Inclusion Criteria:\n\n* Adult male and female active duty military service members aged 18 or older.\n* Diagnosis of at least one mTBI\n* Ability to read, write, and speak English\n* Owns and regularly uses an Apple iPhone or Android smartphone\n\nExclusion Criteria:\n\n* Active psychosis as determined by clinical assessment.\n* Moderate or greater cognitive impairment as indicated by evaluation by the Intrepid Spirit Center clinical team.\n* Completed a Crisis Response Plan within the past year.",{"count":633,"type":23},120,[26],"The study purpose is to test the effect of Crisis Response Planning (CRP) when used as the second method of suicide prevention in military service members who are at risk for suicide due to mild traumatic brain injury (mTBI). CRP will be compared to usual treatment. The treatment will be a 30 to 60 minute session to one person at a time either in-person or using telehealth.",[30,637,638,639,640],"Suicide Prevention","Suicide Risk | Patient","Suicide Risk","Suicide Risk Factor",[642,643,644,645,646,647,648,228],"Clinical Response Planning","CRP","Treatment as Usual","TAU","Military personnel","suicide prevention","traumatic brain injury","2026-01-02",{"date":651,"type":42},"2026-01-08",{"date":207,"type":23},{"date":654,"type":23},"2027-08",{"name":624,"class":49},{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":24,"phases":665,"briefSummary":666,"conditions":667,"keywords":668,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":130},"100533179","vestibular-rehabilitation-app-for-adults-with-dizziness-related-to-mtbi-100533179","NCT06222450","Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI","Rock Steady: A Mobile, Gamified Vestibular Rehabilitation Therapy App for Adults With Dizziness Related to Mild Traumatic Brain Injury","Inclusion Criteria:\n\n* at least 18 years of age,\n* diagnosis of mTBI,\n* documented dizziness (total DHI score ≥ 16) and\u002For imbalance (total functional gait assessment score \\\u003C 23\u002F30 or \\\u003C age-referenced norms)\n\nExclusion Criteria:\n\n* severe neurological disease (e.g., Parkinson's disease, neuropathy),\n* moderate to severe cognitive impairment (\\\u003C 23\u002F30 on the Montreal Cognitive Assessment),\n* significant orthopedic issues that would impact mobility or ability to perform gaze stabilization exercises (e.g., significant cervical dysfunction or pain),\n* vision impairment (best-corrected visual acuity worse than 20\u002F40 in the better eye), and\n* severe depression\u002Fanxiety (≥ 9 on the 4-item Patient health Questionnaire)",{"count":664,"type":23},68,[26],"The goal of this clinical trial is to compare outcomes for standard vestibular rehabilitation home program to a digital vestibular rehabilitation home program in adults with dizziness related to mild traumatic brain injury (mTBI). The main question is whether participants who use the digital format of vestibular rehabilitation improve to a greater extent at discharge than those who use the standard format. Participants will undergo a customized vestibular rehabilitation home exercise program per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training under the supervision of a physical therapist. Participants will complete the gaze stabilization and habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks.\n\nParticipants will be tested before and after the 4-week intervention. At the initial session, the researcher will perform standard clinical tests of the inner ear balance system. Also at the initial session, the researcher will perform standard clinical tests of balance and walking and questionnaires about the impact of dizziness on daily activities. At the final session, the researcher will repeat the tests of balance and walking and questionnaires. Three months after completing the intervention participants will complete an online questionnaire about the impact of dizziness on daily activities.",[30,522],[669,36,670],"vestibular rehabilitation","remote therapeutic monitoring","2025-12-09",{"date":673,"type":42},"2025-12-17",{"date":675,"type":42},"2024-12-01",{"date":677,"type":23},"2026-09-15",{"name":679,"class":49},"Mountain Home Research & Education Corporation",{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":4,"eligibilityCriteria":686,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":273,"enrollmentInfo":687,"targetDuration":4,"studyType":24,"phases":689,"briefSummary":690,"conditions":691,"keywords":693,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":50},"100524528","pilot-study-of-neurofeedback-for-photosensitivity-in-mild-traumatic-brain-injury-100524528","NCT06109909","Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury","A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury","Inclusion Criteria:\n\n* Ages 18-65\n* Documented history of mTBI at least 6 months prior to initial study visit\n* Documented symptoms of photosensitivity\n* Eye exam within the last 12 months documenting best-corrected acuity of 20\u002F20 or better, normal pupillary function, color vision, no abnormalities on OCT scan, and normal Humphrey Visual Field test\n\nExclusion Criteria:\n\n* History of strabismus or amblyopia\n* Significant ocular media opacity that could reduce the amount of light entering the pupil in one or both eyes\n* Previous or current history of retinal or optic nerve pathology in one or both eyes\n* History of stroke and\u002For visual neglect\n* History of neurodegenerative disease (e.g., Parkinson's, multiple sclerosis)\n* History of epilepsy or seizures\n* History of motor tics\n* Current use of medications or substances that may severely affect pupillary response and\u002For increase photosensitivity\n* Individuals with impaired decision-making capacity\n* Illiterate or no English language proficiency",{"count":688,"type":23},36,[26],"The goal of this study is to complete a pilot study testing the feasibility and acceptability of low-intensity pulse-based transcranial stimulation (LIP-tES) neurofeedback intervention for reducing photosensitivity symptoms in Veterans with a history of mild traumatic brain injury (mTBI). The study will also complete resting-state MRI scans to assess neurophysiological markers of photosensitivity and changes associated with LIP-tES intervention.",[30,692],"Photophobia",[694,34],"photophobia","2025-12-08",{"date":697,"type":42},"2025-12-16",{"date":699,"type":42},"2024-01-01",{"date":701,"type":23},"2026-11-30",{"name":77,"class":78}]