[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648363":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":31,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":20,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":20,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"Stony Brook University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VNS Group","EXPERIMENTAL","Group to be implanted with VNS devices",[13],"Device: VNS for TBI group",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","VNS for TBI group","Group will be implanted with VNS device for chronic TBI",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Sima Mofakham, PhD","CONTACT","631-444-1278","sima.mofakham@stonybrookmedicine.edu",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Sima Mofakham","Associate Professor of Neurosurgery",[32],{"name":33,"class":34},"National Institute of Mental Health (NIMH)","NIH","100648363","paired-vns-for-tbi-rehabilitation-100648363",false,"NCT07719829","Paired VNS For TBI Rehabilitation","VNS for TBI","Inclusion Criteria:\n\n* Age 22-80 years\n* History of severe TBI (initial GCS ≤ 8)\n* Regained consciousness with capacity to consent to the study\n* At least six months since injury\n* Full recovery of consciousness with command following (mGCS = 6)\n* Ongoing motor impairment with dependence in activities of daily living (modified Rankin Scale, mRS = 3-4)\n* Clinically stable for VNS implantation\n\nExclusion Criteria:\n\n* No capacity to consent to the study\n* History of stroke\n* History of cognitive disorder or other neurodegenerative disorder\n* History of epilepsy treated by VNS\n* History of brain tumors (primary or metastatic)\n* Requires diathermy\n* Pregnant\n* Previously implanted vagus nerve stimulator\n* Extensive prior neck surgery preventing dissection of the vagus nerve\n* History of severe spasticity, vagus nerve damage, or hearing loss","ALL","22 Years","80 Years",{"count":46,"type":47},20,"ESTIMATED","INTERVENTIONAL",[50],"NA","This study is evaluating whether pairing vagus nerve stimulation (VNS) with structured upper limb rehabilitation therapy can improve arm and hand function in individuals with chronic moderate to severe traumatic brain injury (TBI) and subsequent motor deficits.\n\nMany people who survive a TBI experience long-term weakness, poor coordination, and difficulty using one arm or hand. These motor impairments can significantly affect independence and quality of life. Traditional rehabilitation can help, but recovery is often incomplete.\n\nVagus nerve stimulation (VNS) is an FDA-approved therapy for certain neurological conditions and involves a small device implanted under the skin in the chest with a lead connected to the vagus nerve in the neck. The device delivers mild electrical pulses to the nerve. In this study, VNS will be paired with goal-directed upper limb rehabilitation exercises. The stimulation is delivered during specific movements in therapy sessions. This \"paired stimulation\" approach is designed to enhance neuroplasticity - the brain's ability to reorganize and form new connections - which may improve motor recovery.\n\nThe VNS device used in this study is FDA-approved for other conditions. However, its use paired with rehabilitation for upper limb recovery after traumatic brain injury is investigational.\n\nParticipants in this study will:\n\nUndergo surgical implantation of the VNS device.\n\nParticipate in structured upper limb rehabilitation therapy sessions where stimulation is paired with specific movements.\n\nComplete follow-up visits and assessments to measure changes in arm and hand function, strength, dexterity, and overall recovery.\n\nThe main goal of the study is to determine whether paired VNS and rehabilitation improves upper limb motor function compared to rehabilitation alone. Safety will also be closely monitored, including surgical outcomes and any device-related effects.\n\nThis study may help determine whether VNS paired with rehabilitation is a safe and effective way to enhance motor recovery after traumatic brain injury. Findings from this research could contribute to improved treatment strategies for individuals living with long-term motor impairments following TBI. If the results are promising, future studies plan to also include patients with acute TBI.\n\nParticipation is voluntary. All participants will be carefully evaluated to determine eligibility, and informed consent will be obtained before enrollment.",[53,54],"Traumatic Brain Injury","TBI (Traumatic Brain Injury)","NOT_YET_RECRUITING","2026-08-11",{"date":58,"type":59},"2026-08-13","ACTUAL",{"date":61,"type":47},"2027-01",{"date":63,"type":47},"2031-12",{"name":5,"class":6}]