[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616309":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":18,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":18,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":82,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Penn State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Brain Cooling Treatment","EXPERIMENTAL","Brain cooling consists of a 30-minute seated period, in a dimly lit, quiet room, during which they will wear a Welkins Arctic Cooling Cap V1.30, set at a temperature of 33.0 degrees Fahrenheit. Participants will be asked to remain awake, refrain from observing a screen, and relax to the best of their ability. This brain cooling treatment will occur 5 days per week for 4 total weeks. Brain cooling treatment participants will also continue with their normally prescribed concussion recovery protocol as outlined by their outside clinicians.",[13],"Device: Brain Cooling",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Control participants will maintain their normally prescribed concussion recovery protocol as outlined by their outside clinicians.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Brain Cooling","Brain cooling consists of a 30-minute seated period, in a dimly lit, quiet room, during which they will wear a Welkins Arctic Cooling Cap V1.30, set at a temperature of 33.0 degrees Fahrenheit. Participants will be asked to remain awake, refrain from observing a screen, and relax to the best of their ability. This brain cooling treatment will occur 5 days per week for 4 total weeks.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Owen Griffith, PhD","CONTACT","15709858794","omg5007@psu.edu",[32],{"facility":33,"status":18,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Recreation Building","University Park","Pennsylvania","16802","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-77.85639,40.80201,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":18,"email":30},"Owen M Griffith, PhD","5709858794",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Owen Griffith","Assistant Teaching Professor of Kinesiology","100616309","female-concussion-head-cooling-100616309",false,"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","18 Years","27 Years",{"count":64,"type":65},32,"ESTIMATED","INTERVENTIONAL",[68],"NA","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.",[71,72,73],"Concussion (Diagnosis)","Concussion Post Syndrome","Concussion, Mild",[75,76,77,78,79,80,81],"Brain cooling","Concussion","Neuroinflammation","Mental Health","Cognition","Menstrual cycle","Female","NOT_YET_RECRUITING","2025-12-23",{"date":85,"type":86},"2025-12-26","ACTUAL",{"date":88,"type":65},"2026-01-15",{"date":90,"type":65},"2027-01-01",{"name":5,"class":6},1]