Ischemic Stroke
Conditions
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.
Interventions
OTHERVagus 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of serious adverse events related to vagus nerve stimulation or therapy | 1 year | Total number of serious adverse events reported related to vagus nerve stimulation (VNS) or mobility training |
| Number of participants to complete the study | 1 year | Total number of participants to complete a minimum of 18 therapy sessions |
| Change in Instrumented Gait Assessment score | Baseline, 12 months | Gait speed is calculated as the predetermined distance divided by the time to walk that distance, reported in meters per second (m/s). Improvement in gait velocity is ≥0.05 m/s . |
Countries
United States
Contacts
CONTACTNeurosurgery Research Team
PRINCIPAL_INVESTIGATORRushna Ali, MD
Mayo Clinic
PRINCIPAL_INVESTIGATORMuhib Khan, MD, MBBS
Mayo Clinic
Outcome results
None listed