Recruiting

Vagus Nerve Stimulation

Sponsor:

State University of New York at Buffalo

Code:

NCT07643337

Conditions

Upper Limb Deficit

Stroke Gait Rehabilitation

Stroke

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Vagus Nerve Stimulation Therapy

Study Details

Brief summary:

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

Conditions

Upper Limb Deficit

Stroke Gait Rehabilitation

Stroke

Study ID

NCT07643337

Start date

Jun, 2026

Status verified date

May, 2026

Completion date

Feb 23, 2028

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VNS ON

Receives active stimulation during therapy

sham comparator: VNS OFF

No stimulation during therapy

Interventions

Vagus Nerve Stimulation Therapy

Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ellen M Carl, PhD, CCRP

716-218-1000ecarl@ubns.com

Amylynn M Liskiewicz, MA, CCRP

716-218-1000aliskiewicz@ubns.com

Locations

University at Buffalo Neurosurgery

Recruiting

Buffalo, New York, United States, 14203

Contacts

Ellen M Carl, PhD, CCRP

716-218-1000ecarl@ubns.com

Amylynn M Liskiewicz, MA, CCRP

716-218-1000aliskiewicz@ubns.com

Principal Investigator:

Assaf Berger, MD

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Jun 11, 2026

Last verified

May, 2026

Keywords

  • vagus nerve stimulation
  • stroke rehabilitation
  • stroke related upper limb deficit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-06-11.