The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
New York
University at Buffalo Neurosurgery
RECRUITING
Buffalo
Contact Information
Primary
Ellen M Carl, PhD, CCRP
ecarl@ubns.com
716-218-1000
Backup
Amylynn M Liskiewicz, MA, CCRP
aliskiewicz@ubns.com
716-218-1000
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2028-02-23
Participants
Target number of participants: 24
Treatments
Experimental: VNS ON
Receives active stimulation during therapy
Sham_comparator: VNS OFF
No stimulation during therapy
Related Therapeutic Areas
Sponsors
Leads: State University of New York at Buffalo