A Study Of Vagus Nerve Stimulation (VNS) With Mobility Training For Gait Recovery After Chronic Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vagus nerve stimulation (VNS) paired with mobility training.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Vagus Nerve Stimulation (VNS) Paired With Mobility Training For Gait Recovery After Chronic Ischemic Stroke With Integration Of Biomarker Assessment
Overview
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.
Interventions
- Other 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 measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07291024 · 25-008515