What this study is
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.
What's being tested
- Vagus nerve stimulation (VNS) paired with mobility training
Intervention · OTHER
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.
Study details
- Official title
- Vagus Nerve Stimulation (VNS) Paired With Mobility Training For Gait Recovery After Chronic Ischemic Stroke With Integration Of Biomarker Assessment
- Sponsor
- Mayo Clinic
- Conditions
- Ischemic Stroke
- Enrolling
- 20 people
- Starts
- 2025-12-03
- Est. completion
- 2029-01-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openMayo Clinic in Rochester
Rochester, Minnesota, United States
- Neurosurgery Research Team · Contact507-293-1283
- Rushna Ali, MD · Principal investigator
- Muhib Khan, MD, MBBS · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 25-008515
Principal investigator
Rushna Ali, MD
Mayo Clinic
Principal investigator
Muhib Khan, MD, MBBS
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.