Impact of VNS With Rehab on Gait Post-Stroke

The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke Gait Rehabilitation; Upper Limb Deficit
• Intervention / Treatment: Device: Vagus Nerve Stimulation Therapy

Detailed Description

Stroke is a major cause of disability worldwide and currently there is a lack of effective treatments to improve functional capacity of patients with long-term disability. Vagus Nerve Stimulation (VNS) is FDA-approved for rehabilitation of upper limb deficits in patient with stroke. The device (including Vagus nerve electrodes and chest generator) is permanently implanted prior to the beginning of rehabilitation as standard of care. It is activated by patients and physical therapists during a period of 4.5 months of in-clinic and home therapy. However, so far there have been no approved neuromodulation treatments to improve lower limb functions and gait, which are key for patients' quality of life and their ability to integrate with work and social cycles.

This project will evaluate the impact of VNS on lower limb functions as measured by clinical and laboratory-based analyses of gait in stroke survivors. Patients with both upper and lower limb deficits will be included in this project. After the completion of the standard upper limb VNS-rehabilitation protocol, patients will be double-blindly randomized into 2 groups: a) lower limbs and gait rehabilitation with VNS ON for the duration of therapy; b) lower limbs and gait rehabilitation with VNS OFF.

Based on prior experience with upper limb deficits, we hypothesize that rehabilitation therapy coupled with VNS neuromodulation will elicit functional improvements in lower limb deficits and gait.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen M Carl, PhD, CCRP; Phone Number: 7260 716-218-1000; Email: ecarl@ubns.com
• Study Contact Backup: Name: Amylynn M Liskiewicz, MA, CCRP; Phone Number: 716-218-1000; Email: aliskiewicz@ubns.com

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University at Buffalo Neurosurgery
      • Contact: Ellen M Carl, PhD, CCRP; Phone Number: 7260 716-218-1000; Email: ecarl@ubns.com
      • Contact: Amylynn M Liskiewicz, MA, CCRP; Phone Number: 716-218-1000; Email: aliskiewicz@ubns.com
      • Principal Investigator: Assaf Berger, MD
      • Sub-Investigator: Jonathan Riley, MD
      • Sub-Investigator: Sue Ann Sisto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VNS ON; Receives active stimulation during therapy	Device: Vagus Nerve Stimulation Therapy; Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
Sham Comparator: VNS OFF; No stimulation during therapy	Device: Vagus Nerve Stimulation Therapy; Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale	Absolute change in FMA-LE from baseline to 90 days	90 days post-operation
Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale	Percent change in FMA-LE from baseline to 90 days	90 days post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Functional Assessment - 10-meter walk	Absolute change in gait function as assessed by the timed 10-meter walk from baseline to 90 days	90 days post-operation
Percent Change in Functional Assessment - 10-meter walk	Percent change in gait function as assessed by the timed 10-meter walk from baseline to 90 days	90 days post-operation
Absolute Change in Functional Assessment - 6-minute walk	Absolute change in gait function as assessed by the 6-minute walk from baseline to 90 days	90 days post-operation
Percent Change in Functional Assessment - 6-minute walk	Percent change in gait function as assessed by the 6-minute walk from baseline to 90 days	90 days post-operation
Absolute Change in Functional Assessment - Berg Balance Scale	Absolute change in gait function as assessed by the Berg Balance Scale from baseline to 90 days	90 days post-operation
Percent Change in Functional Assessment - Berg Balance Scale	Percent change in gait function as assessed by the Berg Balance Scale from baseline to 90 days	90 days post-operation
Absolute Change in Functional Assessment - Five Times Sit-to-Stand Test	Absolute change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days	90 days post-operation
Percent Change in Functional Assessment - Five Times Sit-to-Stand Test	Percent change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days	90 days post-operation
Absolute Change in Functional Assessment - Stroke Impact Scale	Absolute change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days	90 days post-operation
Percent Change in Functional Assessment - Stroke Impact Scale	Percent change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days	90 days post-operation
Absolute Change in Functional Assessment - 3D Motion Analysis of Gait	Absolute change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days	90 days post-operation
Percent Change in Functional Assessment - 3D Motion Analysis of Gait	Percent change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days	90 days post-operation

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Assaf Berger, MD, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): February 23, 2028

Study Registration Dates

• First Submitted: May 23, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: vagus nerve stimulation; stroke rehabilitation; stroke related upper limb deficit
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: STUDY00008984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will likely be shared but a plan has not yet been finalized.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No