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NCT Number: NCT07643337

Impact of VNS With Rehab on Gait Post-Stroke

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

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Key information

Conditions

Upper Limb Deficit Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Stroke Gait Rehabilitation Vascular Diseases

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo Neurosurgery

Buffalo, New York, 14203, United States

Location status: Recruiting

Location contact

Amylynn M Liskiewicz, MA, CCRP

CONTACT

[email protected]

716-218-1000

Assaf Berger, MD

PRINCIPAL_INVESTIGATOR

Ellen M Carl, PhD, CCRP

CONTACT

[email protected]

716-218-1000 ext. 7260

Jonathan Riley, MD

SUB_INVESTIGATOR

Sue Ann Sisto, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vagus Nerve Stimulation Therapy

Device

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amylynn M Liskiewicz, MA, CCRP

CONTACT

[email protected]

716-218-1000

Ellen M Carl, PhD, CCRP

CONTACT

[email protected]

716-218-1000 ext. 7260

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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