VNS with Rehab to Improve Gait After Stroke
Official title: The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke
Run by State University of New York at Buffalo · NCT07643337 · Data updated 2026-11-12
This study tests whether adding vagus nerve stimulation to gait rehabilitation helps stroke survivors improve walking.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years to 80 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Status | Recruiting |
| Started | June 2026 |
| Main results expected | December 15, 2027 |
| Study ends | February 23, 2028 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT07643337 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 22-80 with stroke-related upper and lower limb deficits who have residual hand movement and a FAC of 3 or higher and are candidates for VNS therapy.
✕Probably not a fit
Patients lacking lower-limb impairment suitable for gait rehabilitation or those not benefiting from VNS in prior upper-limb rehab may not experience gait improvements.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind study will enroll stroke survivors who have both upper and lower limb deficits and are undergoing VNS-based rehabilitation. After completing the standard upper-limb VNS rehabilitation, participants are assigned to continue gait rehabilitation with the VNS device either turned on or off for the duration of therapy. Researchers will compare clinical and laboratory measures of gait and lower-limb function between the two groups to determine if VNS enhances walking recovery. The trial aims to address the lack of approved neuromodulation options for improving gait after stroke. Participants must meet FDA criteria for VNS and have residual upper-limb movement and sufficient ambulation ability to participate.
Why it matters
Potential benefit: If successful, this approach could improve gait and lower-limb function, enhancing independence and quality of life for stroke survivors.
How similar studies have gone: Prior work suggests VNS may improve upper-limb recovery; this study extends the approach to lower-limb gait and is novel in this domain.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Intact lower limb functions (Fugl-Meyer score=34) * Not a candidate for VNS therapy according to FDA guidelines * Pregnant patients
Where it's running
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University at Buffalo Neurosurgery
Buffalo, New York, United States Recruiting
Study contacts
- Principal investigator: Assaf Berger, MD — University at Buffalo
- Study coordinator: Ellen M Carl, PhD, CCRP
- Email: ecarl@ubns.com
- Phone: 716-218-1000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Split-belt treadmill dosing for early stroke recovery
This program will test how much split-belt treadmill walking with virtual reality people in the first three months after a stroke can safely tolerate.
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Robotic balance training with brain stimulation to improve balance after stroke
This program tests whether adding noninvasive brain stimulation to robotic balance training helps people with chronic stroke who still have balance and walking problems.
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MINT Conditioning to Improve Gait
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Robotic-assisted walking therapy for people in the subacute phase of stroke
This trial will test whether adding robotic-assisted gait training to regular physical therapy helps people 1 to 3 months after a stroke improve their walking and daily function.
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Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
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Personalized exercise program to improve walking in stroke patients
This study tests if a personalized exercise program can help stroke patients improve their walking and balance better than a standard exercise routine.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.