[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631940":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":20,"overallStatus":74,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University of Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Female athletes with a history of concussion and depression","EXPERIMENTAL","Participants are treated with ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg).",[13],"Device: ONE-D TMS protocol and d-cycloserine (125 mg)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","ONE-D TMS protocol and d-cycloserine (125 mg)","Begin the ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg).",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Sara Gould, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","352-273-7381","gouldsj@ortho.ufl.edu",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Virginia Dykes, DAT,LAT,ATC","352-273-7343","jacksve@ortho.ufl.edu",[35],{"facility":36,"status":20,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"UF World Equestrian Center","Ocala","Florida","34482","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-82.14009,29.1872,{"lat":46,"lon":45},[49,50],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100631940","phase-2-optimized-neuroplasticity-enhanced-depression-one-d-transcranial-magnetic-stimulation-tms-treatment-for-female-athletes-with-co-morbid-depression-and-concussion-100631940",false,"NCT07507214","Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion","Optimized, Neuroplasticity Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion","Inclusion Criteria:\n\n* Female athletes, both recreational and professional\n* ages 18-65 years old\n* Concussion as determined by clinical history (at least 72 hours post-diagnosis) and Post-Concussion Symptom Scale (PCSS) score above 7 OR more than 4 total symptoms present\n* Depression as determined by Patient Health Questionnaire - (PHQ-9) score of 10 or greater indicating moderate depression or greater\n* Treatment-resistant depression as determined by previously taken or currently taking an oral antidepressant for at least 6 weeks\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding individuals\n* History of seizures or epilepsy\n* Implanted devices (such as cochlear implants, brain stimulators, aneurysm clips or stents)\n* Participants undergoing treatment with ototoxic medications (aminoglycosides, cisplatin)\n* History of bipolar disorder\n* Pacemakers or implanted defibrillators\n* Allergy or other contraindications to d-cycloserine\n* Other contraindications as determined by PI\n* Unable to provide informed consent due to language or other barriers\n* Incarceration\n* Biological male gender","FEMALE","18 Years","65 Years",{"count":64,"type":65},35,"ESTIMATED","INTERVENTIONAL",[68,69],"PHASE2","PHASE3","Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in concussed athletes have established that there are patterns of local alterations in neural connectivity in the frontal cortex that demonstrate anatomic congruency with transcranial magnetic stimulation (TMS) studies that mapped alternations in neural connectivity to functional and somatic symptoms.6 Thus, there is potential that TMS treatment could decrease both symptom profiles, revolutionizing comorbid treatment options. Possible Benefits:\n\nPrevious studies have showed a 70% remission rate for depression symptoms. It is possible that participants could have improvement in depressive or concussive symptoms after the ONE-D TMS treatment.",[72,73],"Concussion","Depression","NOT_YET_RECRUITING","2026-03-27",{"date":77,"type":78},"2026-04-02","ACTUAL",{"date":80,"type":65},"2026-06-01",{"date":82,"type":65},"2028-06-01",{"name":5,"class":6},1]