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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Chronic ischemic stroke 		Participants with chronic ischemic stroke will be treated with a combination of vagus nerve stimulation and mobility training.
  • 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.

Recruiting Locations

Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905
Contact:
Neurosurgery Research Team
507-293-1283

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Neurosurgery Research Team
507-538-6563
heaser.olyvia@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.