Recruiting

VNS & Mobility Training

Sponsor:

Mayo Clinic

Code:

NCT07291024

Conditions

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vagus nerve stimulation (VNS) paired with mobility training

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, feasibility, and efficacy of vagus nerve stimulation (VNS) paired with mobility training to improve lower extremity function and gait in individuals with chronic ischemic stroke.

Conditions

Ischemic Stroke

Study ID

NCT07291024

Start date

Dec 3, 2025

Status verified date

Feb, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years
  • Ischemic stroke ≥6 months prior to enrollment.
  • Post-stroke lower extremity impairment defined as gait velocity of less than 0.8 m/s on a 10-meter walk test
  • Provision of informed consent

Exclusion Criteria:

  • Intracerebral Hemorrhage
  • Active or prior psychosis or substance abuse within two years.
  • Pre-stroke modified Rankin Scale (mRS) 3-5.
  • Unable to participate in in-clinic rehabilitation.
  • Preexisting neurological disorders affecting gait and mobility, such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, major head trauma.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chronic ischemic stroke

Participants with chronic ischemic stroke will be treated with a combination of vagus nerve stimulation and mobility training.

Interventions

Vagus nerve stimulation (VNS) paired with mobility training

Participants will complete a 6-week in-clinic therapy phase (3 sessions per week), where a physical therapist will lead mobility training with VNS delivered via a handheld magnet. This will be followed by a 6-week at-home phase where participants continue daily exercises and VNS use, supported by weekly video calls to review at home rehabilitation activity and wearable activity monitors for remote monitoring.

Primary outcome measure

  • Number of serious adverse events related to vagus nerve stimulation or therapy [ Time Frame: 1 year ]
  • Number of participants to complete the study [ Time Frame: 1 year ]
  • Change in Instrumented Gait Assessment score [ Time Frame: Baseline, 12 months ]

Central Contacts and Locations

Central contacts

Neurosurgery Research Team

507-538-6563heaser.olyvia@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Neurosurgery Research Team

507-293-1283

Principal Investigator:

Rushna Ali, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-17.