NCT07643337

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jun 2026Feb 2028

First Submitted

Initial submission to the registry

May 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2028

Last Updated

June 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 23, 2026

Last Update Submit

June 8, 2026

Conditions

Upper Limb DeficitStroke Gait RehabilitationStroke

Keywords

vagus nerve stimulationstroke rehabilitationstroke related upper limb deficit

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Absolute Change in Functional Assessment - 10-meter walk

    90 days post-operation

  • Percent Change in Functional Assessment - 10-meter walk

    90 days post-operation

  • Absolute Change in Functional Assessment - 6-minute walk

    90 days post-operation

  • Percent Change in Functional Assessment - 6-minute walk

    90 days post-operation

  • Absolute Change in Functional Assessment - Berg Balance Scale

    90 days post-operation

  • +7 more secondary outcomes

Study Arms (2)

VNS ON

EXPERIMENTAL

Receives active stimulation during therapy

Device: Vagus Nerve Stimulation Therapy

VNS OFF

SHAM COMPARATOR

No stimulation during therapy

Device: Vagus Nerve Stimulation Therapy

Interventions

Vagus Nerve Stimulation TherapyDEVICE

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

VNS OFFVNS ON

Eligibility Criteria

Age22 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Intact lower limb functions (Fugl-Meyer score=34)
  • Not a candidate for VNS therapy according to FDA guidelines
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo Neurosurgery

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Assaf Berger, MD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen M Carl, PhD, CCRP

CONTACT

716-218-1000ecarl@ubns.com

Amylynn M Liskiewicz, MA, CCRP

CONTACT

716-218-1000aliskiewicz@ubns.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurosurgery

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 11, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

February 23, 2028

Last Updated

June 11, 2026

Record last verified: 2026-05

Locations

US(1)