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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGNumber of serious adverse events related to vagus nerve stimulation or therapy
Total number of serious adverse events reported related to vagus nerve stimulation (VNS) or mobility training
Time frame: 1 year
Number of participants to complete the study
Total number of participants to complete a minimum of 18 therapy sessions
Time frame: 1 year
Change in Instrumented Gait Assessment score
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 .
Time frame: Baseline, 12 months
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