NCT07643337 · State University of New York at Buffalo
Impact of VNS With Rehab on Gait Post-Stroke
What this study is about
This is a forward-looking, double-blinded, randomly assigned controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.
View original scientific description
This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.
Interventions
DEVICE
Vagus Nerve Stimulation Therapy
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
Primary outcome measures
Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
Time frame: 90 days post-operation
Absolute change in FMA-LE from baseline to 90 days
Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
Time frame: 90 days post-operation
Percent change in FMA-LE from baseline to 90 days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Buffalo, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations