[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-brain-injury-tbi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-brain-injury-tbi":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,119,147,174,205],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100362752","phase-2-allopregnanolone-in-chronic-complex-traumatic-brain-injury-100362752",false,"NCT04003285","Allopregnanolone in Chronic Complex Traumatic Brain Injury","Novel Regenerative Therapeutic in Chronic Complex TBI","ALLO","Inclusion Criteria:\n\n* 21-62 years of age, any ethnic group, either sex\n* History of mild TBI since 2001 and service in the U.S. Military since 9\u002F11\u002F01 (OEF\u002FOIF\u002FOND era)\n* The investigators will adhere to the operational definition of mild TBI suggested by the World Health Organization Task Force, with the exception of seizure and Glasgow Coma Scale score criteria (not available for these participants) with 1 or more of the following:\n\n  * confusion or disorientation\n  * loss of consciousness for 30 minutes or less\n  * post-traumatic amnesia for less than 24 hours\n  * and\u002For other transient neurological abnormalities such as focal signs, and intracranial lesion not requiring surgery\n* Ability to participate fully in the informed consent process\n* HAM-D score 14 (HAM-D range for moderate depression=14-18)\n* Participants will meet DSM-5 criteria for major depressive disorder (by SCID)\n\n  * The presence of psychotic features will be exclusionary\n  * Single episodes or recurrent episodes will be permissible for study entry (the investigators will examine treatment responses in those who have had single depressive episodes versus those who have had multiple depressive episodes in exploratory sensitivity analyses\n* BPI (Brief Pain Inventory, Short Form) 'current' pain intensity rating item score 4 (scale of 0-10)\n\n  * Pain must be musculoskeletal in nature\n* No anticipated need to alter psychiatric medications for 14-day duration of study involvement\n* No changes in psychotropic or behavioral interventions during the study or in the 2 weeks prior to study enrollment\n* Concomitant medications for co-occurring medical conditions are permissible for stable medical conditions that are reasonably well-controlled\n\n  * for example, hypertension medications, statins, and oral hypoglycemic medications would generally be permissible if they appear to be effectively treating the underlying condition\n\nExclusion Criteria:\n\n* Participants with current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern\n* Medications that could potentially confound study outcomes (for example, prednisone) are exclusionary\n* Current DSM-5 diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI\n* Female participants who are pregnant or breast-feeding\n* Known allergy to study medication\n* Benzodiazepine, barbiturate, or opioid use within the last 2 weeks is exclusionary\n* Substance use disorder (DSM-5), other than nicotine use disorder\n* A serious medical illness, defined as an illness that requires hospitalization for additional care at the time of screening or one that has required hospitalization in the last month.\n\n  * Any co-occurring medical illness should have a history of stable outpatient management\n* Report of a history of seizures, a history of stroke, a history of prostate cancer (or any other cancer other than non-melanoma skin cancer), a history of myocardial infarction, the presence of congestive heart failure, or any other serious health condition that would likely preclude safe study participation in the medical opinion of the PI or in consultation with the participant's PCP\u002Fother health care provider\n* Use of oral contraceptives, a hormone-releasing IUD, or other hormonal supplementation such as estrogen or progesterone, as there is a theoretical risk that a metabolite such as ALLO could potentially impact efficacy of oral contraceptives or estrogen replacement","ALL","21 Years","62 Years",{"count":21,"type":22},132,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study will determine if allopregnanolone (ALLO) improves depression and pain symptoms in patients who have a history of mild traumatic brain injury (TBI) \\[primary endpoints\\]. The investigators will also determine if ALLO improves functional outcome \\[secondary endpoint\\]. Participants in this study will receive an intravenous infusion of either ALLO or placebo. Behavioral assessments will be conducted during the infusion and at several time points post-infusion.",[28],"Traumatic Brain Injury (TBI)",[30,31,32],"Brain Injuries, Traumatic","Depression","Pain","NOT_YET_RECRUITING","2026-06-03",{"date":36,"type":37},"2026-06-04","ACTUAL",{"date":39,"type":22},"2026-09-01",{"date":41,"type":22},"2027-06-01",{"name":43,"class":44},"VA Office of Research and Development","FED",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":83,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":45},"100630855","intensive-multimodal-neurorehabilitation-targeting-neuroplasticity-in-pediatric-neurodevelopmental-and-chromosomal-disorders-100630855","NCT07493096","Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders","Functional and Neurodevelopmental Outcomes Following Intensive Multimodal Neurorehabilitation in Pediatric Patients With Neurodevelopmental Disorders, Including Chromosomal Abnormalities","GEN-HOPE","Inclusion Criteria:\n\n* Pediatric participants between approximately 4 and 12 years of age at the time of enrollment.\n* Diagnosed with or presenting with neurodevelopmental, neurologic, or genetic conditions, including but not limited to:\n\n  * cerebral palsy\n  * autism spectrum disorder\n  * developmental delay\n  * hypoxic ischemic encephalopathy (HIE)\n  * traumatic brain injury\n  * sensory processing disorder\n  * chromosomal or genetic abnormalities\n  * Demonstrate functional impairments in one or more neurodevelopmental domains, including:\n* motor coordination or motor planning\n* sensory processing\n* attention or executive functioning\n* oculomotor or visual processing\n* communication\n* emotional or behavioral regulation\n* activities of daily living\n* Enrolled in and able to participate in a two-week intensive therapy program consisting of approximately 2.5 hours per day\u002F 5 days per week\n\n  * Able to complete baseline and post-program clinical assessment using clinician-observed or caregiver-reported measures.\n  * Parent or legal guardian able to provide informed consent and participate in reporting functional outcomes when applicable.\n\nExclusion Criteria:\n\n* Medical instability or acute medical condition that would prevent safe participation in an intensive therapy program.\n* Severe uncontrolled seizure activity or other neurologic condition that would interfere with participation in structured therapeutic activities, as determined by the treating clinician.\n* Behavioral or psychological conditions that would prevent safe engagement in the therapy environment despite appropriate support.\n* Inability to attend or complete the full two-week intensive program.\n* Lack of sufficient baseline or post-intervention data to assess change in functional performance.\n* Concurrent participation in another structured intervention or clinical study that would confound interpretation of functional outcomes, at the discretion of the investigator.","4 Years","12 Years",{"count":57,"type":22},100,"OBSERVATIONAL","This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program. The program is designed for children with neurodevelopmental disorders, including but not limited to cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy (HIE), and chromosomal or genetic abnormalities.\n\nParticipants receive individualized therapy sessions for approximately 2.5 hours per day over a two week period. The intervention is not standardized but is tailored to each child's specific needs and may include components such as sensory integration, motor planning, reflex integration, oculomotor training, executive functioning activities, communication support, and other brain based therapeutic approaches.\n\nThe purpose of this study is to observe changes in functional abilities, including attention, motor coordination, emotional regulation, communication, and activities of daily living. Outcomes are assessed using clinician observation and parent reported changes before and after the intensive program, with limited follow-up when available.\n\nThis study does not assign participants to a specific treatment as part of a research protocol. Instead, it collects real world data from children already participating in a clinical therapy program to better understand potential benefits of intensive, individualized neurorehabilitation approaches.",[61,62,63,64,65,66,67,68,69,70,71,72,73,28,74,75,76,77,78,79,80,81,82],"Neurodevelopmental Disorders","Neurodevelopmental Disorders (NDD)","Neurodevelopmental Disorders and Developmental Abnormalities","Developmental Delay (Disorder)","Cerebral Palsy (CP)","Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment","Cerebral Palsy Infantile","Cerebral Palsy Spastic Hemiplegic","Cerebral Palsy, Dyskinetic","Autism Spectrum Disorder","Autism Spectrum Disorder (ASD","Hypoxic Ischemic Encephalopathy","Hypoxic Ischemic Encephalopathy (HIE)","Sensory Processing Disorder","Chromosomal Abnormalities","Genetic Disorders","Down Syndrome (Trisomy 21)","Fragile X Syndrome (FXS)","RETT Syndrome With Proven MECP2 Mutation","Williams Syndrome","22q11.2 Deletion Syndrome","Sensorimotor Integration",[84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,61,102,103,104,105,106,107],"Photobiomodulation","Low-Level Laser Therapy","Vibration Therapy","Tactile Stimulation","Cognitive Training","Behavioral Therapy","Intensive Therapy","Pediatric Neurorehabilitation","Multimodal Therapy","Neuroplasticity","Sensory Integration","Reflex Integration","Motor Planning","Executive Function","Emotional Regulation","Functional Outcomes","Activities of Daily Living","High Frequency Therapy","Rehabilitation","Child Development Disorders","Occupational Therapy","Physical Therapy Modalities","Early Intervention","Cognitive Therapy","RECRUITING","2026-03-19",{"date":111,"type":37},"2026-03-25",{"date":113,"type":37},"2026-03-01",{"date":115,"type":22},"2036-12-30",{"name":117,"class":118},"Healing Hope International","OTHER",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":45},"100610469","cognitive-rehabilitation-for-treatment-of-anger-in-veterans-with-tbi-and-ptsd-100610469","NCT07227987","Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI and PTSD","Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI (Traumatic Brain Injury) and PTSD (Post-traumatic Stress Disorder)","CALM","Inclusion Criteria:\n\nInclusion Criteria for Veterans\n\n* U.S. Veteran who served in one of the military branches (Army, Navy, Marines, Air Force, or Coast Guard) since 9\u002F11\u002F01\n* Meets criteria for TBI\n* Meets criteria for PTSD or subthreshold PTSD\n* Reports anger problems began after their head injury\n* Reports current problems with cognitive function\n* At least 18 years old\n* Fluent and literate in English\n* Able to provide voluntary, informed consent to participate.\n\nInclusion Criteria for Family members or Friends:\n\n* Over age 18;\n* Family member\u002Ffriend of Veteran who served in one of the military branches (Army, Navy, Marines, Air Force, National Guard) post-9\u002F11 and who meets TBI and PTSD inclusion criteria\n* Fluent and literate in English\n* Able to provide voluntary, informed consent to participate.\n\nExclusion Criteria:\n\n* Does not own a smartphone.\n* Does not have a trusted support person, e.g., spouse, family member, or friend for enrollment","18 Years",{"count":57,"type":22},[130],"NA","This randomized clinical trial will enroll 100 Veteran-family\u002Ffriend dyads to test the efficacy of CALM in treating anger in TBI and PTSD. The investigators hypothesize that compared to an active control group, Veterans randomized to the CALM group will demonstrate:\n\n* Significantly larger decreases in anger dysregulation, impulsivity, and executive dysfunction.\n* Significantly larger improvements in social and adaptive functioning including less aggression.\n* Significantly larger reduction in PTSD symptoms and suicidal ideation.\n\nThe study targets Veterans who experience difficulties with anger and impulsivity due to TBI and PTSD. These issues are common, with up to 38% of Veterans with TBI also having PTSD. These conditions often make it challenging for Veterans to control their emotions and interact successfully in social and work settings. Our research will test the CALM (Cognitive Applications for Life Management) mobile app, which helps Veterans manage their goals, remember important tasks, and improve their attention. Initial tests of CALM have shown it can reduce levels of anger and related issues in Veterans. The investigators will conduct a study with 100 pairings of Veterans and a family member or friend. These pairs will be randomly assigned to one of two groups: one using the CALM mobile platform and the other receiving brain health education. Both groups will use their assigned intervention for three months and will receive support through videoconference calls at the beginning, middle, and end of the program.",[28,133],"Posttraumatic Stress Disorder (PTSD)",[28,135,136,137],"Posttraumatic stress Disorder (PTSD)","Mobile app","Veterans","2026-03-11",{"date":140,"type":37},"2026-03-13",{"date":142,"type":22},"2026-04-01",{"date":144,"type":22},"2028-12-31",{"name":146,"class":118},"Duke University",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":154,"enrollmentInfo":155,"targetDuration":157,"studyType":58,"phases":4,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":45},"100571811","hemodynamic-abi-monitor-100571811","NCT06725108","Hemodynamic ABI Monitor","Non-invasive Continuous Hemodynamic Monitoring in Acute Brain Injury","Inclusion:\n\nPatients who are:\n\n* Admitted to the University of Chicago Medical Center Neurocritical Care Unit\n* Adults between 18 years and 80\n* Admitted with Traumatic brain injury blunt and penetrating or nontraumatic intracerebral hemorrhage\n* post-resuscitation Glasgow Coma Scale (GCS) \\\u003C9\n\nExclusion:\n\nPatients who were:\n\n* Pre-existing heart failure\n* Moribund or neurological exam suggesting imminent brain death (bilateral, fixed and dilated pupils) on admission\n* Major polytrauma or admitted to the surgical trauma critical care service\n* Prisoner","80 Years",{"count":156,"type":22},50,"6 Months","The goal of this observational study is to explore the relationship of heart function with the course and outcomes after traumatic brain injuries and nontraumatic intracerebral hemorrhage. The goal is to explore association between routinely collected hemodynamic and brain monitoring data.\n\nParticipants already taking intervention A as part of their regular medical care and the investigators will follow up with participants 6 months after discharging the hospital.",[28,160],"Intracerebral Hemorrhage",[162,163,164],"Hemodynamic","Acute brain injury","Monitoring","2026-03-03",{"date":167,"type":37},"2026-03-04",{"date":169,"type":37},"2024-12-06",{"date":171,"type":22},"2026-12-06",{"name":173,"class":118},"University of Chicago",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":45},"100616138","phase-1-low-tech-treatments-for-obstructive-sleep-apnea-100616138","NCT07301710","Low-Tech Treatments for Obstructive Sleep Apnea","Myofunctional Therapy for Obstructive Sleep Apnea in U.S. Service Members With and Without Traumatic Brain Injury","Inclusion Criteria:\n\n* New diagnosis of OSA (AHI, ≥ 5) or failure of first-line OSA treatment;\n* Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months;\n* Ability to follow directions and perform the required exercises;\n* Age between 18-65 yr.\n\nExclusion Criteria:\n\n* Current use of OSA treatment;\n* Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia);\n* Severe nasal obstruction; 4) severe ankyloglossia; 4) craniofacial abnormality; 5) severe pulmonary disease; 6) severe post-traumatic stress disorder; 7) very severe insomnia; 8) body mass index (BMI) ≥30 kg\u002Fm2","65 Years",{"count":183,"type":22},60,[185,25],"PHASE1","The overall purpose of this study is to compare changes in sleep outcomes in people with obstructive sleep apnea (OSA) depending on their participation in one of two behavioral interventions; both involve drinking water and breathing. A second purpose is to compare outcomes between people who have sustained a traumatic brain injury (TBI) and those with no history of TBI. The main questions it aims to answer are whether sleep quality improves after 3-months of high-resistance versus low-resistance exercises, and whether people have different outcomes depending on their history of TBI.",[188,28],"Obstructive Sleep Apnea (OSA)",[190,191,192,193,194,195],"Obstructive Sleep Apnea","Myofunctional Therapy","Traumatic Brain Injury","Randomized Controlled Trial","Oropharyngeal Exercises","Respiratory Resistance Training","2026-02-11",{"date":198,"type":37},"2026-02-17",{"date":200,"type":37},"2026-01-29",{"date":202,"type":22},"2027-12",{"name":204,"class":44},"Uniformed Services University of the Health Sciences",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":181,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"100584193","spinal-stimulation-and-gait-training-to-improve-mobility-in-tbi-100584193","NCT06886152","Spinal Stimulation and Gait Training to Improve Mobility in TBI","Transcutaneous Spinal Stimulation and Gait Training to Improve Mobility and Motor Control in Individuals With Traumatic Brain Injury","DOD SS","Inclusion Criteria:\n\n* Have weakness on at least one side of my body.\n* No injury to my unaffected side in 6 months.\n* Be cleared by a physician to participate in this study.\n* Have had a non-penetrating TBI at least 2 years ago. A non-penetrating injury is an injury where my skull remained closed and no object entered it.\n* Have enough strength to use a hemiwalker or walker.\n* Be between 18-65 years of age.\n* Be medically stable for at least 6 months before enrolling. This means that I have not had an emergency room visit, hospitalization, or medical procedure (such as a surgery) during this period of time.\n* Able to walk 10 yards with minimal assistance without an ankle-foot orthosis (brace)\n* Able to respond to and tolerate surface stimulation, as determined by study staff\n* Have the ability to communicate in English.\n* Have stable blood pressure.\n* Be willing and able to give informed consent.\n* Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.\n\nExclusion Criteria:\n\n* Have must have not had physical or occupational therapy or treatment for a balance disorder within 30 days prior to study enrollment. I must not participate in physical or occupation therapy throughout the duration of the study to avoid affecting the study results.\n* Have any medical issues that affect my unaffected side (such arthritis, fracture, etc.).\n* Have skin issues that would prevent me from being able to use the surface stimulation (such as a open wound or rash).\n* Have a pre-existing condition that may make it difficult for me to participate in exercise. (uncontrolled hypertension as described by a physician, heart disease, abnormal heart rate or rhythm, or congestive heart failure).\n* Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.\n* Have an implanted medical or metallic device.\n* Reduced sensation in my lower limbs and stimulation locations.\n* Have Botox injections in my legs up to 3 months prior to enrolling.\n* Have physical therapy for walking.\n* Have uncontrolled seizure disorder (such as epilepsy)\n* Have nervous system-related issues (for example Parkinson's disease, multiple sclerosis).\n* Major changes to my medications throughout the study\n* Have bone or muscle issues unrelated to traumatic brain injury that interfere with my walking or limit my range of motion in my legs.\n* Be currently pregnant. Because of potential risk to the fetus, women of child bearing potential will be required to have a pregnancy test before they can enroll in this study. If I am female, and have a positive pregnancy test, I will not be enrolled.\n* Have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the stimulation or participate in walking training TMS Specific - Exclusion (those with these exclusions can still participate in other parts of the study)\n* I have a history of seizure disorder or have a close family member (parent, brother, sister, or child) who has a seizure disorder.\n* I have had unexplained fainting spells.\n* I have had an active migraine headaches.\n* I have a past or current history of ringing in the ears (tinnitus) or severe hearing problems.\n* I am currently taking or withdrawing from any medication that would increase my risk of seizure (determination made in consultation with study physician).\n* I have a history of alcohol or drug abuse in the prior 3 years.\n* I have nerve damage outside of my brain or spinal cord (such as in an arm or leg).\n* I am unwilling to participate in TMS.",{"count":214,"type":22},30,[130],"The purpose of this research study is to assess the effects of receiving transcutaneous spinal stimulation while performing walking exercises compared to completing walking exercises without spinal stimulation for individuals with hemiplegic TBI.",[192,28,218],"Hemiplegia and Hemiparesis","2025-08-25",{"date":221,"type":37},"2025-09-02",{"date":223,"type":22},"2025-09-01",{"date":225,"type":22},"2028-09-01",{"name":227,"class":118},"Kessler Foundation",2]