[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07643337":3,"trial-entities:NCT07643337":141,"trial-summary:NCT07643337":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":49,"sex":86,"minimum_age":87,"maximum_age":88,"healthy_volunteers":15,"eligibility_criteria":89,"std_ages":102,"locations":105,"central_contacts":133,"overall_officials":136,"references":139,"see_also_links":140},"NCT07643337","STUDY00008984","Impact of VNS With Rehab on Gait Post-Stroke","The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke","RECRUITING","2028-02-23","2026-05","2026-06-11","2026-06","State University of New York at Buffalo","OTHER",false,"This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.","Stroke is a major cause of disability worldwide and currently there is a lack of effective treatments to improve functional capacity of patients with long-term disability. Vagus Nerve Stimulation (VNS) is FDA-approved for rehabilitation of upper limb deficits in patient with stroke. The device (including Vagus nerve electrodes and chest generator) is permanently implanted prior to the beginning of rehabilitation as standard of care. It is activated by patients and physical therapists during a period of 4.5 months of in-clinic and home therapy. However, so far there have been no approved neuromodulation treatments to improve lower limb functions and gait, which are key for patients' quality of life and their ability to integrate with work and social cycles.\n\nThis project will evaluate the impact of VNS on lower limb functions as measured by clinical and laboratory-based analyses of gait in stroke survivors. Patients with both upper and lower limb deficits will be included in this project. After the completion of the standard upper limb VNS-rehabilitation protocol, patients will be double-blindly randomized into 2 groups: a) lower limbs and gait rehabilitation with VNS ON for the duration of therapy; b) lower limbs and gait rehabilitation with VNS OFF.\n\nBased on prior experience with upper limb deficits, we hypothesize that rehabilitation therapy coupled with VNS neuromodulation will elicit functional improvements in lower limb deficits and gait.",[19,20,21],"Upper Limb Deficit","Stroke Gait Rehabilitation","Stroke",[23,24,25],"vagus nerve stimulation","stroke rehabilitation","stroke related upper limb deficit","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},24,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","Vagus Nerve Stimulation Therapy","Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)",[39,40],"VNS OFF","VNS ON",[42,46],{"measure":43,"description":44,"timeFrame":45},"Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale","Absolute change in FMA-LE from baseline to 90 days","90 days post-operation",{"measure":47,"description":48,"timeFrame":45},"Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale","Percent change in FMA-LE from baseline to 90 days",[50,53,56,59,62,65,68,71,74,77,80,83],{"measure":51,"description":52,"timeFrame":45},"Absolute Change in Functional Assessment - 10-meter walk","Absolute change in gait function as assessed by the timed 10-meter walk from baseline to 90 days",{"measure":54,"description":55,"timeFrame":45},"Percent Change in Functional Assessment - 10-meter walk","Percent change in gait function as assessed by the timed 10-meter walk from baseline to 90 days",{"measure":57,"description":58,"timeFrame":45},"Absolute Change in Functional Assessment - 6-minute walk","Absolute change in gait function as assessed by the 6-minute walk from baseline to 90 days",{"measure":60,"description":61,"timeFrame":45},"Percent Change in Functional Assessment - 6-minute walk","Percent change in gait function as assessed by the 6-minute walk from baseline to 90 days",{"measure":63,"description":64,"timeFrame":45},"Absolute Change in Functional Assessment - Berg Balance Scale","Absolute change in gait function as assessed by the Berg Balance Scale from baseline to 90 days",{"measure":66,"description":67,"timeFrame":45},"Percent Change in Functional Assessment - Berg Balance Scale","Percent change in gait function as assessed by the Berg Balance Scale from baseline to 90 days",{"measure":69,"description":70,"timeFrame":45},"Absolute Change in Functional Assessment - Five Times Sit-to-Stand Test","Absolute change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days",{"measure":72,"description":73,"timeFrame":45},"Percent Change in Functional Assessment - Five Times Sit-to-Stand Test","Percent change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days",{"measure":75,"description":76,"timeFrame":45},"Absolute Change in Functional Assessment - Stroke Impact Scale","Absolute change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days",{"measure":78,"description":79,"timeFrame":45},"Percent Change in Functional Assessment - Stroke Impact Scale","Percent change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days",{"measure":81,"description":82,"timeFrame":45},"Absolute Change in Functional Assessment - 3D Motion Analysis of Gait","Absolute change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days",{"measure":84,"description":85,"timeFrame":45},"Percent Change in Functional Assessment - 3D Motion Analysis of Gait","Percent change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days","ALL","22 Years","80 Years",{"inclusion":90,"exclusion":97,"raw_text":101},[91,92,93,94,95,96],"Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy","≥22 years and ≤ 80 years","Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits","Residual active movement in the affected limb's thumb and other 2 fingers","Stroke-related deficits in the lower limbs and gait with a Functional Ambulation Category (FAC) ≥3","Able to follow simple instructions and independently walk short distances with or without external support or leg orthoses, but without manual contact with another person",[98,99,100],"Intact lower limb functions (Fugl-Meyer score=34)","Not a candidate for VNS therapy according to FDA guidelines","Pregnant patients","Inclusion Criteria:\n\n* Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy\n* ≥22 years and ≤ 80 years\n* Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits\n* Residual active movement in the affected limb's thumb and other 2 fingers\n* Stroke-related deficits in the lower limbs and gait with a Functional Ambulation Category (FAC) ≥3\n* Able to follow simple instructions and independently walk short distances with or without external support or leg orthoses, but without manual contact with another person\n\nExclusion Criteria:\n\n* Intact lower limb functions (Fugl-Meyer score=34)\n* Not a candidate for VNS therapy according to FDA guidelines\n* Pregnant patients",[103,104],"ADULT","OLDER_ADULT",[106],{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":111,"contacts":112,"geoPoint":130},"University at Buffalo Neurosurgery","Buffalo","New York","14203","United States",[113,119,122,125,128],{"name":114,"role":115,"phone":116,"phoneExt":117,"email":118},"Ellen M Carl, PhD, CCRP","CONTACT","716-218-1000","7260","ecarl@ubns.com",{"name":120,"role":115,"phone":116,"email":121},"Amylynn M Liskiewicz, MA, CCRP","aliskiewicz@ubns.com",{"name":123,"role":124},"Assaf Berger, MD","PRINCIPAL_INVESTIGATOR",{"name":126,"role":127},"Jonathan Riley, MD","SUB_INVESTIGATOR",{"name":129,"role":127},"Sue Ann Sisto, MD",{"lat":131,"lon":132},42.88645,-78.87837,[134,135],{"name":114,"role":115,"phone":116,"phoneExt":117,"email":118},{"name":120,"role":115,"phone":116,"email":121},[137],{"name":123,"affiliation":138,"role":124},"University at Buffalo",[],[],{"nct_id":4,"conditions":142,"biomarkers":143},[21],[],{"nct_id":4,"found":15,"summary":145,"prompt_version":145},null]