Impact of VNS With Rehab on Gait Post-Stroke

June 8, 2026 updated by: Assaf Berger, State University of New York at Buffalo

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ellen M Carl, PhD, CCRP
  • Phone Number: 7260 716-218-1000
  • Email: ecarl@ubns.com

Study Contact Backup

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:
        • Principal Investigator:
          • Assaf Berger, MD
        • Sub-Investigator:
          • Jonathan Riley, MD
        • Sub-Investigator:
          • Sue Ann Sisto, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
90 days post-operation
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
90 days post-operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute Change in Functional Assessment - 10-meter walk
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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
Time Frame: 90 days post-operation
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Assaf Berger, MD, University at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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