[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"concussion-post-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:concussion-post-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,74,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100642487","post-concussion-sleep-and-brain-heart-functions-100642487",false,"NCT07636408","Post-Concussion Sleep and Brain-heart Functions","Enhancing Sleep to Improve Brain-heart Functions in People With Persistent Post-concussion Symptoms","CBT-pI","Inclusion Criteria:\n\n1. Adults 18 years and older\n2. Experiencing persisting post-concussion symptoms \\> 4 weeks but no more than 12 months post-injury as measured based on home-made screening questions and the Sport Concussion Assessment Tool (SCAT6)\n3. Having a Sleep Condition Indicator score suggestive of insomnia (SCI =\u002F\\\u003C 15, adapted to enable the inclusion of insomnia symptoms over at least 1 month)\n4. Meeting diagnostic criteria for insomnia disorder on the SCID\n5. Having a smartphone, tablet or computer and willingness to install a sleep intervention application on it\n\nExclusion Criteria:\n\n1. Having undergone another CBT-I program within the past 6 months\n2. Current diagnosis of bipolar disorder, psychotic disorder, or substance use disorder confirmed by the M.I.N.I.\n3. Self-reported substance use disorder (i.e., alcohol, cannabis, or illicit drugs) or =\u002F\\> monthly use of illicit drugs reported on item-2 of the WHO-ASSIST (except tobacco, alcohol, and cannabis)\n4. Body mass index \\> 45\n5. Shift work or rotating shifts within 1 month of study entry\n6. Recent travel to a different time zone (leaving 1 week of recovery per time zone difference)\n7. Any clinically significant neurological disorder aside from concussion (including seizure disorder)\n8. Signs of sleep apnea as reflected by combined profiles on the Sleep Disorders Symptoms Checklist-25 and Epworth Sleepiness Scale\n9. Unstable psychotropic medications (need to be on a stable dose for at least 1 month prior to study start)\n10. Insufficient English skills to provide informed consent, understand study instructions, or fill out questionnaires","ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","This project is designed as a randomized controlled trial (RCT), with an active control group. Sleep and heart rate will be monitored at home for 1 week before and after the intervention. Questionnaires will be completed from home before, during and 8 weeks after the end of the Intervention. The Cognitive Behavioural Therapy for Insomnia, adapted for post-concussed individuals (CBT-pI) and control interventions, will be delivered on a digital online platform over an 8-week period. Participants in the control arm will be offered CBT-pI after the follow-up period. All intervention arms will be delivered as adjuncts to standard clinical care. All other treatments received during the intervention will be documented.",[27,28],"Insomnia","Concussion Post Syndrome",[30,31],"Cognitive Behavioral Therapy for Insomnia","digital therapy","NOT_YET_RECRUITING","2026-06-08",{"date":35,"type":36},"2026-06-11","ACTUAL",{"date":38,"type":21},"2026-06",{"date":40,"type":21},"2027-04",{"name":42,"class":43},"University of Ottawa","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100642854","phase-4-intravenous-metoclopramide-versus-intravenous-acetaminophen-for-acute-concussion-treatment-100642854","NCT07634393","Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment","A Randomized Study of Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment","IMPACT","Inclusion Criteria:\n\n* Adults presenting to one of the study emergency departments (EDs)\n* Acute minor traumatic brain injury\u002Fconcussion as defined by the Zurich Consensus Statement, including symptoms in somatic, cognitive, emotional, behavioral, physical, cognitive impairment, or sleep domains\n* ED visit occurring within 7 days of the head injury\n* Overall pain intensity greater than \\>=6 on a 0-10 scale\n* Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10\n* Reported post-concussion symptoms were not present prior to the injury\n* Treating attending physician plans to administer a parenteral medication\n\nExclusion Criteria:\n\n* Already treated with an anti-dopaminergic medication for post-concussion symptoms\n* Contraindications to study medications, including:\n* Pheochromocytoma\n* Seizure disorder\n* Parkinson's disease\n* Use of monoamine oxidase (MAO) inhibitors\n* Use of anti-rejection transplant medications\n* Pregnant patients will not be excluded because both acetaminophen and metoclopramide are commonly used during pregnancy.",{"count":53,"type":21},200,[55],"PHASE4","The IMPACT study is a randomized, double-blind clinical trial evaluating two commonly used intravenous medications - metoclopramide and acetaminophen - for treating acute post-concussion symptoms in emergency department patients after mild head injury. The study aims to determine which treatment more effectively improves symptoms such as headache, dizziness, nausea, concentration difficulties, and emotional changes within the first week after injury.\n\nParticipants will be enrolled across two Montefiore emergency departments and followed using a validated post-concussion symptom questionnaire. Findings from this study may help improve evidence-based treatment strategies for patients experiencing concussion-related symptoms after head trauma.",[28,58],"Head Trauma Injury",[60,61,62,63],"Concussion","Head Trauma","Acetaminophen","Metoclopramide","2026-06-06",{"date":66,"type":36},"2026-06-10",{"date":68,"type":21},"2026-08-01",{"date":70,"type":21},"2028-08-04",{"name":72,"class":43},"Montefiore Medical Center",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":81,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":73},"100616309","female-concussion-head-cooling-100616309","NCT07303933","Female Concussion Head Cooling","The Association Between Head Cooling and Cognition, Neuroinflammatory Cytokines, Menstrual Cycle, Sleep Patterns, Mental Health and Concussions","Inclusion Criteria:\n\n1. Require that any participant is 18-27 years old\n2. Require that participants be English speakers\n3. Require that participants are females\n4. Require that persons be able to provide consent for themselves\n\nExclusion Criteria:\n\n1. Exclude persons under 18 years old or over 27 years old\n2. Exclude persons taking anti-inflammatory drugs (both prescription and OTC), or those who will have taken them within 24 hours prior to Visit 1\n3. Exclude smokers and former smokers, as defined by CDC. (Anyone who smokes daily or who has smoked at least 100 cigarettes in their lifetime)\n4. Those with scalp infections, sun burns, skin cancers, and\u002For prior surgical scars should not participate\n5. Those with presence of an active infection (including a dental infection)\n6. Exclude persons who have migraines\n7. Exclude persons taking mood stabilizer medications\n8. Exclude persons who have consumed alcohol within 48 hours prior to study participation.\n9. Exclude persons who are males","FEMALE","27 Years",{"count":84,"type":21},32,[24],"This research is being done to examine the benefits of a 28 day head cooling intervention on cognition, inflammation of the brain, sleep quality, menstrual symptom interaction, and mood in acutely concussed females. Brain cooling has been shown to cause temporary symptom relief after traumatic brain injury, but its implications for decreasing timeline of full concussion recovery, particularly in females during periods of confounding neuropsychological menstrual symptoms, remains unexplored.",[88,28,89],"Concussion (Diagnosis)","Concussion, Mild",[91,60,92,93,94,95,96],"Brain cooling","Neuroinflammation","Mental Health","Cognition","Menstrual cycle","Female","2025-12-23",{"date":99,"type":36},"2025-12-26",{"date":101,"type":21},"2026-01-15",{"date":103,"type":21},"2027-01-01",{"name":105,"class":43},"Penn State University",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":17,"minAge":114,"maxAge":18,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":73},"100421616","auditory-slow-wave-enhancement-after-concussion-100421616","NCT04770116","Auditory Slow Wave Enhancement After Concussion","The Effect of Sleep and Slow Wave Enhancement on Recovery From a Concussion in Children and Adolescents: A Longitudinal, Randomized, Double-Blind, and Sham-Controlled Study","Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Age between 6 and 18 years\n* Good knowledge of German of the patient and at least one legal representative\n* Patients: Presentation to the Emergency of the University Children's Hospital Zurich because of a concussion (diagnosed by medical doctor)\n\nExclusion Criteria:\n\n* Preterm birth (\\\u003C 37 gestational weeks)\n* Diagnosed hearing disorder\n* Psychiatric, syndromal, or neurological pre-existing condition (except for previous concussion)\n* Skin disorder\u002Fskin problem in the face\u002Fear area that requires Treatment\n* Usage of neuroactive substances\n* Patients: Concomitant injury that requires intense pain medication or a prolonged hospital stay, or that causes limited use of the dominant Hand\n* Patients: Previous moderate-severe TBI\n* Controls: Injury of the dominant hand, on head, arm, or leg\n* Controls: Previous TBI (of any severity)\n\nAdditional inclusion criteria for the optional MRI measurement for both groups:\n\n* Age at least 8 years\n* Fulfilment of all MRI safety criteria\n* The participant and the legal representative would want to know about incidental findings.\n* Girls: No pregnancy or breast feeding.",true,"6 Years",{"count":116,"type":21},120,[24],"The prevalence of a traumatic brain injury (TBI) in children and adolescents is around 30% with 70-90% being classified as mild (concussion). Because the brain of a child is still developing, a TBI can have devastating effects and possibly creates lifetime challenges. Sleep seems to play an important role in the post-concussion recovery process. Auditory stimulation during sleep has been shown to reliably boost slow waves, a solid marker for the depth of sleep, and can thus be used to deepen sleep. This study aims to investigate the effects of sleep enhancement via auditory stimulation on recovery after a concussion in children and adolescents in their home. Therefore, half of the patients receive one week of auditory stimulation during deep sleep at their home using a mobile device. The other half follows the same study protocol, but no tones are administered (sham). Cognitive tests as well as symptom questionnaires are used to assess the recovery process. It is hypothesized that the patients in the intervention group will recover better than the ones who haven't received the intervention. Additionally, a group of children and adolescents who never sustained a concussion is included as a control.",[28],[121,122,123,124],"sleep","auditory stimulation","post-concussive symptoms","in-home EEG","RECRUITING","2024-12-04",{"date":128,"type":36},"2024-12-09",{"date":130,"type":36},"2021-05-31",{"date":132,"type":21},"2026-03-31",{"name":134,"class":43},"University Children's Hospital, Zurich"]