Development of At-Home Transcutaneous Auricular Vagus Nerve Stimulation for Post-Stroke Rehabilitation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior;

• Ability to give consent;

• Unilateral limb (left or right) weakness with Fugl Meyer-Upper Extremity Scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks;

• active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks;

• Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Katie Tucker
tuckekat@musc.edu
843-792-9502
Time Frame
Start Date: 2024-10-28
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 5
Treatments
Experimental: Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training
Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: National Institute of General Medical Sciences (NIGMS)

This content was sourced from clinicaltrials.gov