Actively Recruiting
Vagus Nerve Stimulation Paired With Mobility Training for Gait Recovery After Chronic Ischemic Stroke with Biomarker Assessment
Led by Mayo Clinic · Updated on 2026-02-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of vagus nerve stimulation (VNS) combined with mobility training to improve walking ability and leg function in people who have had a chronic ischemic stroke. This study aims to evaluate the safety, feasibility, and effectiveness of this combined treatment approach. The trial is sponsored by Mayo Clinic and focuses on individuals who experienced their stroke at least six months ago. Participants will undergo a 6-week period of in-clinic therapy, attending three sessions per week. During these sessions, a physical therapist will guide mobility exercises while VNS is delivered using a handheld magnet. After this, participants will continue with a 6-week at-home rehabilitation phase, performing daily exercises and using VNS. Weekly video calls and wearable activity monitors will support and track their progress remotely. Throughout the study, researchers will assess the number of serious side effects related to VNS or therapy over one year, the number of participants who complete the study, and changes in walking ability measured by an instrumented gait assessment at the start and after 12 months. Participants will engage in various assessments during the trial, and safety will be closely monitored. The total duration of participation includes the therapy phases and follow-up evaluations over the course of a year.
CONDITIONS
Brief Title
A Study Of Vagus Nerve Stimulation (VNS) With Mobility Training For Gait Recovery After Chronic Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ischemic stroke occurred 6 months or more before enrollment
- Difficulty walking with a gait speed less than 0.8 meters per second on a 10-meter walk test
- Able to provide informed consent
You will not qualify if you...
- Presence of intracerebral hemorrhage
- Active or past psychosis or substance abuse within the last two years
- Pre-stroke disability level of 3 to 5 on the modified Rankin Scale
- Unable to participate in in-clinic rehabilitation sessions
- Preexisting neurological conditions affecting walking or mobility such as Parkinson's disease, ALS, MS, dementia, or major head injury
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants complete a 6-week in-clinic therapy phase with 3 sessions per week where a physical therapist leads mobility training paired with vagus nerve stimulation. This is followed by a 6-week at-home phase involving daily exercises and vagus nerve stimulation use, supported by weekly video calls and remote monitoring with wearable activity monitors.
18 in-clinic sessions and weekly video calls for 6 weeks
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
N
Neurosurgery Research Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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