[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-traumatic-brain-injury-concussion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-traumatic-brain-injury-concussion":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,80,106,139,166,196,221],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100623907","phase-1-psychologically-informed-cervicovestibular-rehabilitation-pic-rehab-for-mild-traumatic-brain-injury-a-feasibility-trial-100623907",false,"NCT07402733","Psychologically Informed Cervicovestibular Rehabilitation (PIC Rehab) for Mild Traumatic Brain Injury: A Feasibility Trial","PIC Rehab: Psychologically Informed Cervicovestibular Rehabilitation for Mild Traumatic Brain Injury: A Feasibility Trial","PIC Rehab","Inclusion Criteria:\n\n* Reporting dizziness, neck pain and\u002For headaches for at least 14 days following mild traumatic brain injury\u002Fconcussion who are referred for cervicovestibular physiotherapy with one or more impairments related to the vestibular, oculomotor, sensorimotor, cervical spine, neuromuscular control.\n\nExclusion Criteria:\n\n* Patients who have previously undergone a session of cervicovestibular physiotherapy will be excluded","ALL","18 Years","70 Years",{"count":21,"type":22},34,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Mild traumatic brain injuries (\"mTBIs\") affect over 480,000 Canadians each year. While many individuals recover in the initial 4 weeks following mTBI, in up to 30% of individuals symptoms and functional impairments often persist leading to significant disability, decreased quality of life and participation in education, physical and occupational related activities. An assessment that evaluates multiple systems is recommended for individuals with mTBI, often involving multiple health care professionals to assess different areas of function (e.g. oculomotor, vestibular, balance, mood, cognition, etc). Current evidence supports the use of cervicovestibular rehabilitation (CVPT) (which includes physiotherapy techniques aimed at treating the neck, balance, visual and other sensory systems) and symptom-tolerated exercise. Evidence suggests that collaborative care, cognitive behavioural therapy (CBT) may be of benefit. However, the added value of CVPT and CBT in combination co-designed by patients and community partners has not yet been evaluated in mTBI. In other pain and dizziness conditions, the addition of CBT to physical\u002Fvestibular rehabilitation yielded improved outcomes. Here we take a transdisciplinary team-based approach to evaluate an integrated combination of CVPT and CBT.\n\nThis study will recruit a total of 34 people ages 18-70 years old who have ongoing symptoms following an mTBI for more than two weeks. The first 17 patients will receive CVPT along and the second 17 patients will receive psychologically informed CVPT (\"PIC\" Rehab). This study will help determine if combined therapy has an additive effect on helping patients recovery from mTBI.",[28],"Mild Traumatic Brain Injury, Concussion",[30,31,32,33,34],"rehabilitation","cervical spine","vestibular","cognitive behavioural therapy","treatment","NOT_YET_RECRUITING","2026-05-28",{"date":38,"type":39},"2026-06-01","ACTUAL",{"date":38,"type":22},{"date":42,"type":22},"2026-10-30",{"name":44,"class":45},"Sport Injury Prevention Research Centre","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100582183","core-cognitive-optimization-through-rehabilitation-and-education-study-100582183","NCT06859996","CORE (Cognitive Optimization Through Rehabilitation and Education) Study","A Comparison of Two Interventions for Chronic Cognitive Difficulties After mTBI","CORE","Inclusion Criteria:\n\n* \\>18 years of age\n* Evidence of self-reported mTBI sustained in adulthood at least 3 months prior to the date of study enrollment (clinical discretion allowed for mTBI in late adolescence) AND documentation of diagnosed or suspected mTBI as defined by American Congress of Rehabilitation Medicine (ACRM) criteria in the medical record (e.g., on the problem list, has a diagnosis, encounter for a TBI, diagnosis via a TBI evaluation, or documented in a clinical note, etc).\n* Endorsement of at least moderate symptoms (score of 3 or higher) on at least one of the cognitive items (forgetfulness, poor concentration, taking longer to think) from the Rivermead Postconcussion Symptom Questionnaire.\n* Ability to read, speak and understand English enough to participate in healthcare in English without a translator.\n* Willingness to participate in audio-recorded treatment sessions.\n* Willingness to be randomized to treatment condition.\n* Willingness to use clinical video teleconferencing (CVT) for research appointments (including be on camera for treatment sessions).\n* Able to use and have access to a smart phone, tablet, or computer with internet access in private setting for treatment sessions.\n* Willingness to refrain from participation in any other clinical trial or interventional study while participating in this study\n\nExclusion Criteria:\n\n* History of neurologic injury or illness other than mTBI that can affect cognitive functioning (e.g., any lifetime severe TBI \\[Glasgow Coma Score (GCS)\\\u003C=8; loss of consciousness (LOC)\\> 1 hour; posttraumatic amnesia (PTA)\\>1 week\\], seizure disorder, multiple sclerosis, neurodegenerative disorder). Any definitively diagnosed moderate TBI is exclusionary, but injuries that are in the mild to moderate range are eligible pending clinical discretion. If available records and\u002For self-reported information do not allow for a definitive determination of whether an injury is mild or moderate, then clinician discretion will be used to determine eligibility.\n* Alcohol abuse (operationalized as scoring 15 or more if male or 13 or more if female on the Alcohol Use Disorders Identification Test), or high-risk illicit drug use (as defined by modified Tobacco, Alcohol, Prescription Medications and Substance Use\u002FMisuse (TAPS) Tool subscale scores \\> 2) in the past 3 months. Indication of alcohol\u002Fdrug abuse or dependence in medical record is also sufficient to meet this exclusion criteria, per PI discretion.\n* Active suicidal ideation\u002Fintent indicating significant risk, per PI discretion.\n* Unstable medical or psychiatric condition (e.g., mania, psychotic symptoms) that would interfere with study participation, per PI discretion.\n* Behavioral issues noted in the record or observed during the screening process that would interfere with appropriate or safe CVT participation or study procedures, per PI discretion.\n* Prior participation in the On-TRACC intervention.\n* Significant cognitive impairment that would limit ability to engage in treatment (as indicated by more than 1 error on a 6-item screener).\n* Planned life events that would interfere with study participation during active treatment phase (e.g., major surgery, moving out of state, extended travel).\n* Current participation in another clinical trial or interventional study.",{"count":56,"type":22},354,[58],"NA","Mild traumatic brain injury (mTBI) affects millions of individuals worldwide every year. It has long been thought that the vast majority of individuals who sustain a mTBI experience natural recovery with little or no intervention and return to baseline functioning within days to weeks of injury. However, recent large studies have demonstrated that a substantial number of individuals experience prolonged symptoms (e.g., cognitive impairment, headaches, affective symptoms). These symptoms, termed \"Persistent Post-concussive Symptoms\" (PPCS) are associated with significant functional disability and reduced quality of life (QOL) and can last for years post-injury. While PPCS can include affective, cognitive, and somatosensory\u002Fvestibular symptoms, objective and subjective cognitive symptoms - particularly in the domains of attention, memory, processing speed, and executive function - are among the most commonly reported following mTBI. There is currently no gold-standard intervention to address these symptoms. To address this gap, our research group developed a brief cognitive rehabilitation intervention called Tools for Rehabilitation and Cognitive Care (or On-TRACC).\n\nThe goals of this clinical trial are:\n\nAIM 1: Compare the efficacy of On-TRACC to a psychoeducation control on reduction of self-reported cognitive post-concussive symptoms (Aim 1.1) and overall neurobehavioral post concussive symptoms and (Aim 1.2) following treatment and at 3-month follow-up (Aim 1.3) in a randomized clinical trial of community-dwelling adults with mTBI.\n\nAIM 2: Compare the efficacy of On-TRACC and psychoeducation on change in secondary outcomes, including cognitive self-efficacy, compensatory strategy use, self-management skills, and quality of life at post-treatment and 3-month follow-up.\n\nExploratory AIM 3: Compare the efficacy of On-TRACC and psychoeducation on: primary and secondary outcomes at 6-months post-treatment and (Aim 3.1) explore whether engaging in On-TRACC leads to subsequent engagement in care by assessing whether there is a different level of participation in optional intervention booster sessions in the post-intervention period (Aim 3.2).\n\nAll participants will:\n\n* Complete a series of assessments\n* Complete 6 treatment sessions via telehealth (either On-TRACC or psychoeducation)\n\nAll participants will have the option of:\n\n* Attending weekly \"Booster Sessions\" between 3 and 6-months post-treatment\n* Completing neuropsychological assessments at 2 timepoints during the study",[61],"Mild Traumatic Brain Injury; Concussion",[63,64,65,66,67,68],"cognitive training","self-management","Veterans","concussion","psychoeducation","clinical trial","RECRUITING","2026-04-14",{"date":72,"type":39},"2026-04-20",{"date":74,"type":39},"2025-10-27",{"date":76,"type":22},"2029-09",{"name":78,"class":45},"University of Washington",2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":46},"100605747","symptom-exacerbation-following-mental-imagery-in-patients-with-persistent-post-concussive-symptoms-100605747","NCT07166536","Symptom Exacerbation Following Mental Imagery in Patients With Persistent Post-Concussive Symptoms","Characterization of Headache and Dizziness Exacerbation Following Mental Imagery in Patients With Persistent Post-Concussive Symptoms","Inclusion Criteria:\n\n1. Current patients of Reut Rehabilitation Hospital or individuals who were discharged from the hospital within the past 12 months.\n2. Diagnosis of mild Traumatic Brain Injury, concussion, blast injury, or cervical whiplash injury.\n3. More than 3 months since the event.\n4. Presence of headaches and\u002For dizziness that began after the injury and have persisted continuously or intermittently.\n5. Exclusion of other potential causes of headaches, such as non-healed fractures, chronic inflammation\u002Finfection, increased intracranial pressure, or meningeal injury.\n6. Headache intensity of at least 3\u002F10 on the VAS scale.\n\nExclusion Criteria:\n\n1. Significant cognitive impairment preventing informed consent (Mini-Mental State Examination score \\\u003C20 or Montreal Cognitive Assessment score \\\u003C20, as per IRB requirements).\n2. Diagnosed central neurological conditions such as multiple sclerosis, Parkinson's disease, stroke, or brain tumor.\n3. Presence of known pyramidal or extrapyramidal neurological signs.\n4. Significant language impairment interfering with communication.\n5. Psychiatric disorders significantly affecting communication.\n6. Use of vestibular-suppressant medication (e.g., Cinnarizine) with an inability or unwillingness to discontinue treatment 24 hours prior to testing.\n\nWithdrawal Criteria:\n\n1\\. Oculomotor dysfunction affecting multiple oculomotor functions.",{"count":88,"type":22},60,[58],"Background: Mild Traumatic Brain Injury (mTBI) often results in persistent emotional, cognitive, and somatic symptoms-such as headaches and dizziness. These symptoms impose a significant burden, yet their underlying mechanisms remain unclear.\n\nPredictive processing theories suggest that persistent symptoms may result from learned perceptual errors, particularly in individuals with high negative affectivity. This framework may help explain ongoing persistent post-concussive symptoms (PPCS) in the absence of identifiable pathology, which have been linked to various psychological factors.\n\nMental imagery (MI) is thought to engage similar predictive processes. There is evidence that MI of symptom-triggering movements may exacerbate symptoms in individuals with chronic somatic conditions. However, this phenomenon has not been studied in PPCS patients. Investigating symptom provocation through MI may yield novel insights into the neuropsychological mechanisms sustaining PPCS and potentially contribute to the development of therapeutic tools for this population.\n\nObjectives:\n\n1. Documenting the exacerbation of headache and dizziness following provocative mental imagery (imagery of movements or scenarios that elicit these symptoms in real life) in patients with PPCS.\n2. Comparing changes in headache and dizziness after provocative MI versus neutral MI (imagery of movements or scenarios that do not elicit these symptoms in real life).\n3. Comparing patients who experience symptom exacerbation following mental imagery to those who do not.\n4. Describing associations between symptom exacerbation and negative affectivity, anxiety, depression, catastrophizing, and lower daily functioning.\n\nMethods: A cross-sectional study will be conducted on adult patients experiencing PPCS following mTBI. Participants will be recruited through convenience sampling from a computerized hospital database of Reuth Rehabilitation Hospital, based on inclusion and exclusion criteria.\n\nAfter signing an informed consent form, participants will be invited to attend 2 to 3 sessions, each lasting 1 to 2 hours. During these sessions, a licensed physiotherapist will conduct a comprehensive clinical assessment, including: Completion of self-report questionnaires; A vestibular examination; Anamnestic interview and clinical assessment of individual movement- and scenario-related triggers for dizziness and headaches; Symptom provocation testing using mental imagery of the identified triggers.",[28,92,93],"Post Concussive Syndrome, Chronic","Post Traumatic Headache",[95,96,97,66],"mild traumatic brain injury","Persistent Post-Concussion Symptoms","mental imagery","2026-04-09",{"date":70,"type":39},{"date":101,"type":39},"2025-09-07",{"date":103,"type":22},"2026-12-31",{"name":105,"class":45},"Reuth Rehabilitation Hospital",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":18,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100613926","mindfulness-based-intervention-for-pediatric-mild-traumatic-brain-injury-100613926","NCT07272941","Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury","Multisite Randomized Clinical Trial: Mindfulness-Based Intervention for Mild Traumatic Brain Injury (MBI-4-mTBI)","MBI-4-mTBI","Inclusion Criteria:\n\n* Participants presenting to five PERC EDs after sustaining a direct or indirect head injury\n* Aged 12 through 17.99 years\n* Diagnosed with a definite or suspected concussion, defined by the American College of Rehabilitation Medicine definition\n* Score ≥6 on the 5P rule\n* Suffered the index injury in the previous 48 hours\n* Proficient in English or French\n\nExclusion Criteria:\n\n* Glasgow Coma Scale ≤13\n* Abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required, but may be performed if clinically indicated)\n* Neurosurgical operative intervention, intubation or intensive care required\n* Multi-system injuries with treatment requiring hospital admission, operating room or procedural sedation in ED (Note: hospital admission for observation or management of ongoing concussion symptoms is not an exclusion criteria)\n* Severe neurological developmental delay resulting in communication difficulties\n* Intellectual disability\u002Fmental retardation, autism spectrum disorder (history of attention deficit hyperactivity disorder, learning disability, or Tourette's syndrome is not an exclusion)\n* Intoxication at the time of ED presentation as per clinician judgment\n* No clear history of trauma as primary events (e.g., seizure, syncope or migraine)\n* Prior psychiatric hospitalization\n* Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression are not exclusionary)\n* Inability to obtain a proper written informed consent\u002Fassent (language barrier, absence of parental authority, developmental delay, intoxication, patient too confused to consent, etc.)\n* Legal guardian not present (certain forms need be completed by parents\u002Flegal guardians)\n* No internet or mobile\u002Ftablet access.\n* Previously enrolled in phase 1 or phase 2 of the feasibility trial or the efficacy trial.","12 Years",{"count":116,"type":22},362,[58],"Formal MBIs, such as Mindfulness-Based Stress Reduction (MBSR), have been shown to increase resiliency and teach affect regulation. However, these formal interventions may not be suitable for acutely concussed youth as they are costly, not easily accessible (trained therapists are needed), and require commitment from parents and children for in-person weekly meetings and at-home practice of learned skills for 8 to 16 weeks. Further, MBSR programs may not be readily accessible immediately after a concussion. With the increasing use of mobile phones and tablets in youth, mobile health offers a powerful platform for mental health interventions. Advantages of app-based interventions include constant availability, greater access, tailored content, lower cost, immediate delivery, and increased service capacity and efficiency. Therefore, the anticipated benefit is to show the efficacy of a pragmatic and low-cost intervention and reduce barriers to care through a novel, innovative and accessible MBI treatment program. This will have both a benefit to public health and expand our understanding of the impact of MBIs on pediatric recovery.",[120,28,121],"Concussions","Concussion Mild",[95,123,66,124,125,126,34,127,128],"mtbi","intervention","meditation","quality of life","Persistent post-concussive symptoms","mindfulness","2026-03-17",{"date":131,"type":39},"2026-03-18",{"date":133,"type":22},"2026-05",{"date":135,"type":22},"2029-12",{"name":137,"class":45},"Children's Hospital of Eastern Ontario",5,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":151,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":46},"100628818","advancement-of-vestibular-intervention-via-portable-electrical-stimulator-vipes-100628818","NCT07466589","Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)","Inclusion Criteria:\n\n1. Age 18-55\n2. Diagnosed with concussion, evaluated at the University of Michigan\n3. Symptoms persistent greater than 4-6 weeks\n4. Self-reported imbalance\n5. Must be able to attend in-person session.\n\nNo racial\u002Fethnic groups will be excluded, although all participants must be fluent speakers of English.\n\nExclusion Criteria:\n\n1. Anyone under the age of 18 or over the age of 55\n2. Presence of prior diagnosis of peripheral vestibulopathy\n3. Women who are pregnant\n4. Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).","55 Years",{"count":147,"type":22},32,[58],"The goal is to assess the potential benefit of stochastic galvanic vestibular stimulation (sGVS) in improving patient performance with respect to balance, gait, and\u002For overall vestibular function for individuals with known deficits in vestibular performance as a result of a mild traumatic brain injury (mTBI).",[28],[152,95,66,153,154,32,155],"mTBI","balance","gait","GVS","2026-03-09",{"date":158,"type":39},"2026-03-12",{"date":160,"type":39},"2025-08-22",{"date":162,"type":22},"2026-03",{"name":164,"class":165},"Vivonics, Inc.","INDUSTRY",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100545420","wearable-technology-to-characterize-and-treat-mtbi-subtypes-biofeedback-based-precision-rehabilitation-100545420","NCT06381674","Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation","SuBTyPE","Inclusion Criteria:\n\n* For all Aims, participants may be either civilians, active duty military, or Veterans, and must:\n\n  1. have a diagnosis of mTBI based on VA\u002FDoD criteria\n  2. be between 18-60 years old,\n  3. be able to stand unassisted for 10 minutes at a time\n  4. be outside of the acute stage (\\> 2 weeks post-concussion) but within 6 months of their most recent mTBI and still reporting symptoms\n  5. have at least some measurable deficit in Vestibular\u002FOcular categories based on Concussion Profile Screen\n  6. have sufficient vision (corrected or uncorrected) for unassisted reading and performance of everyday personal tasks and independent community ambulation\n  7. have adequate hearing (without amplification) adequate for engaging in close-range personal or telephone conversation.\n\nExclusion Criteria:\n\n* Participants must not:\n\n  1. have had or currently have any other injury, medical, or neurological illness that could potentially explain balance or vision deficits (e.g., CNS disease, stroke, epilepsy, greater than mild TBI, Meniere's, bilateral vestibular loss, recent lower extremity or spine orthopedic injury that impairs mobility) this includes unresolved symptoms from previous concussions\n  2. meet criteria for moderate to severe substance-use disorder within the past month, as defined by DSM-V\n  3. display behavior that would significantly interfere with the validity of data collection or safety during the study\n  4. be in significant pain during the evaluation (\\> 7\u002F10 by patient subjective report)\n  5. be a pregnant female (balance considerations)\n  6. been hospitalized for any brain injuries (separate from the emergency department)\n  7. have significant joint pain or recent musculoskeletal injury that limits walking or mobility\n  8. have had any major surgeries in the past year or amputation\n  9. use an assistive device\n  10. unable to stand barefoot\n  11. currently receiving rehabilitation services for their mTBI or injuries related to their concussion (if rehabilitation has been completed more than 1 month ago participants may still be included).","60 Years",{"count":175,"type":22},100,[58],"Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and\u002For auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy.",[28,179,180],"Rehabilitation","Balance Impairment",[182,66,32,183,153,30,184,185],"mild traumatic brain injury (mTBI)","ocular","biofeedback","wearable sensors","2025-10-10",{"date":188,"type":39},"2025-10-14",{"date":190,"type":39},"2024-06-13",{"date":192,"type":22},"2028-09-30",{"name":194,"class":45},"Oregon Health and Science University",3,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":17,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":46},"100582970","phase-2-a-randomised-double-blind-placebo-controlled-phase-2a-pilot-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-onp-002-in-adults-with-mild-traumatic-brain-injury-100582970","NCT06870240","A Randomised, Double-blind, Placebo-controlled Phase 2a Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONP-002 in Adults With Mild Traumatic Brain Injury","7.2.1 Inclusion Criteria\n\nParticipants with suspected concussion presenting to the emergency department will be included in the study only if they satisfy all the following criteria:\n\n1. Participant or legal representative is willing and capable of giving written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.\n2. Adult males and females, 18 to 55 years of age (inclusive) at screening.\n3. Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg\u002Fm2, with a body weight (to 1 decimal place) ≥ 50 kg at screening.\n4. Must be diagnosed with a mTBI by all the following measures:\n\n   * Negative CT scan for acute traumatic lesions\n   * Elevated Blood Glial fibrillary acidic protein (GFAP) (≥22 pg\u002FmL)\n   * Glasgow Coma Scale (GCS) score \\>12\n   * Neurological Signs and Symptoms Checklist with history of loss\u002Faltered consciousness\n   * Neurological PTA, LOC and AOC checklist\n5. Must be able to receive 1st dose of study drug within 12 hours of injury.\n6. No evidence of bleeding from the nose or visual full occlusion of the nasal cavity after a macroscopic nasal examination.\n7. Female patients if of childbearing potential (defined as any female who has experienced menarche and who has not undergone surgical sterilisation and is not postmenopausal):\n\n   * Must be known to not be pregnant based on a urine or blood test prior to first dose administration.\n   * Must not be breastfeeding, lactating or planning pregnancy during the study period.\n   * Must agree not to become pregnant or donate ova for at least 33 days after last dose of study drug.\n   * Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception \\[Section 10.2.3\\]) from screening until at least 33 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.\n8. Male participants must:\n\n   * Agree not to donate sperm from signing the consent form until at least 93 days after the last dose of study drug.\n   * If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception (defined as use of a condom combined with use of highly effective method of contraception) from signing the consent form until at least 93 days after the last dose of study drug.\n   * If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom from signing the consent form until at least 93 days after the last dose of study drug.\n9. Have suitable venous access for blood sampling.\n10. The patient must agree to have to give their blood without ownership to the repository for blood biomarker analysis.\n11. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\n7.2.2 Exclusion Criteria\n\nParticipants will be excluded from the study if they meet any of the following criteria:\n\n1. History or presence of other significant disorder that at the discretion of the PI or delegate is considered \"serious\" classifying the participant as \"not a good candidate\" for the study.\n2. Presence of penetrating brain injury.\n3. Treatment with an investigational drug in another clinical trial within 60 days or 5 half-lives of the other investigational drug (whichever is longer) prior to the first administration of study drug in this trial.\n4. Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.\n\n7.3 Screen Failures Participants who consent to participate in the study but fail to meet the eligibility criteria at any point during the Screening Period and until randomisation are defined as screening failures. The reason for each screening failure will be recorded on the appropriate screening and enrolment log.\n\n7.4 Re-Screening Participants who fail screening are not permitted to be re-screened. 7.5 Participant Withdrawal Criteria\n\nParticipants will be advised that they are free to withdraw from the study at any time for any reason or, if necessary, the PI (or delegate) may discontinue a participant from the study to protect the participant's wellbeing. A participant may voluntarily withdraw or be withdrawn from the study for reasons including, but not limited to, the following:\n\n* The need to take medication which may interfere with study measurements;\n* Intolerable\u002Funacceptable AEs;\n* Noncompliance of the participant with the protocol;\n* Pregnancy, as indicated in Section 12.7;\n* Withdrawal of consent; or\n* If, in the PI's (or delegate's) judgement, it is in the participant's best interest.\n\nThe Sponsor will be notified as soon as possible of any participant withdrawals. The date and reasons for withdrawal will be recorded in the eCRF.\n\nAny participant who prematurely discontinues study drug, should have all scheduled assessments performed and attend all scheduled follow-up visits. If a participant withdraws or is withdrawn from the study, an attempt should be made to perform the Early Termination Visit assessments detailed in the Schedule of Assessments (SoA) in Section 1.3.\n\n7.6 Participant Replacement Final confirmation of eligibility will be conducted prior to administration of the first dose of study drug (Day 1).\n\nAutomatic replacement of participants is allowed if a participant withdraws or is withdrawn prior to administration of the first dose of study drug.\n\nParticipants who withdraw or are withdrawn from the study after administration of the first dose of study drug for reasons other than occurrence of a treatment-related SAE, may be replaced at the discretion of the PI (or delegate) and following consultation with the Sponsor.\n\nAny participants enrolled as replacements will be allocated to the same study treatment (treatment arm) as the participant replaced.\n\n\\-\n\n\\-","18 Months","60 Months",{"count":205,"type":22},40,[207],"PHASE2","This is a Phase IIa, randomized, double-blind, placebo-controlled pilot study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ONP-002 in adults with mild traumatic brain injury (mTBI).\n\nBroadly, a mTBI, often referred to as a concussion, is a type of head trauma that causes temporary disruption to brain function, usually resulting from a blow to the head, fall, or sudden movement, and is often characterised by symptoms of headache, dizziness, confusion, memory problems, and difficulty concentrating, without significant loss of consciousness or structural brain damage on imaging tests.\n\nThe study will enroll up to 40 participants into 2 parallel treatment arms, of 20 patients each, who will receive either 16 mg (8 mg twice daily \\[BID\\]) intranasal (IN) ONP-002 or placebo, at 8-12-hour intervals consecutively for 5 days with a total of up to 9 doses.",[28],[211],"concussion, traumatic brain injury, biomarkers, cognition, visual-motor","2025-03-10",{"date":214,"type":39},"2025-03-11",{"date":216,"type":22},"2025-06-01",{"date":218,"type":22},"2026-03-31",{"name":220,"class":165},"Oragenics, Inc.",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":79},"100572583","repetitive-transcranial-magnetic-stimulation-paired-with-augmented-reality-to-alter-concussion-symptoms-100572583","NCT06735157","Repetitive Transcranial Magnetic Stimulation Paired with Augmented Reality to Alter Concussion Symptoms","Inclusion Criteria:\n\n* Male or female aged 18-65 years\n* Diagnosis of mTBI according to the American Congress of Rehabilitation Medicine Diagnostic Criteria (Silverberg et al., 2023). All participants have diagnosis confirmed with Dr. Rathbone before enrollment.\n* Persistent dizziness beyond 3-months following the initial head injury.\n* Comprehension of spoken and written English language or have a language interpreter present for all study visits.\n\nExclusion Criteria:\n\n* History of chronic dizziness unrelated to concussive events.\n* Contraindications to TMS: presence of pacemaker, metal\u002Felectrical\u002Fmagnetic implants not including titanium, known history of untreated or uncontrolled psychological disorders, pregnancy, history of seizure or diagnoses of epilepsy, taking medications that increase the risk of seizure.\n* Inability to continue current medical therapies for the duration of the study.\n* If imaging was done at the time of injury, individuals with a positive CT head will be excluded from the study","65 Years",{"count":205,"type":22},[58],"This study aims to determine whether the delivery of brain stimulation paired with a balance training task can improve symptoms of dizziness for individuals experiencing these symptoms due to concussion. The main questions it aims to answer are:\n\n* Does repetitive transcranial magnetic stimulation (rTMS) paired with balance training improve the symptoms of dizziness in individuals with persistent dizziness due to concussion?\n* Is the proposed rTMS and balance training protocol feasible in this population?\n\nResearchers will compare results from a sham rTMS group with those from a real rTMS group to see if any observed changes are from the placebo effect rather than the expected effects of real rTMS.\n\nParticipants will receive pulses of rTMS to the area of the brain responsible for control of movement and then be asked to interact with digital objects using augmented reality glasses for 14 days over 3 weeks.",[28,232,233],"Chronic Dizziness","Vestibular Problem",[235,236,237,238,239,95,240,241,242,243],"Concussion","Dizziness","Transcranial magnetic stimulation","augmented reality","repetitive transcranial magnetic stimulation","intermittent theta burst stimulation","accelerated iTBS","balance training","vestibular rehabilitation therapy","2025-01-09",{"date":246,"type":39},"2025-01-13",{"date":248,"type":22},"2025-01-01",{"date":250,"type":22},"2025-12-01",{"name":252,"class":45},"McMaster University"]