Impact of VNS With Rehab on Gait Post-Stroke

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT07643337
Status
Recruiting
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Conditions

  • Stroke
  • Stroke Gait Rehabilitation
  • Upper Limb Deficit

Eligibility Criteria

Sex
ALL
Age
22 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Vagus Nerve Stimulation Therapy — DEVICE
    Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)

Study Details

This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 15, 2027
Completion
Feb 23, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VNS ON
    Receives active stimulation during therapy
  • Sham Comparator: VNS OFF
    No stimulation during therapy

Primary Outcome Measure

Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale [ Time Frame: 90 days post-operation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University at Buffalo NeurosurgeryBuffaloNew York14203
Ellen M Carl, PhD, CCRP
[email protected]
716-218-1000
Amylynn M Liskiewicz, MA, CCRP
[email protected]
716-218-1000
Assaf Berger, MD (PRINCIPAL_INVESTIGATOR)
Jonathan Riley, MD (SUB_INVESTIGATOR)
Sue Ann Sisto, MD (SUB_INVESTIGATOR)

Find similar trials in Buffalo, NY

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University at Buffalo Neurosurgery· Buffalo, NY

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