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.
This study seeks to advance prior research conducted here at MUSC exploring the use of transcutaneous auricular vagus nerve stimulation (taVNS) paired with motor rehabilitation to improve motor function post-stroke. Early evidence from a recently completed NIH-funded, clinical trial suggests that our new approach of delivering electrical stimulation to the ear at the same time as motor rehabilitation double the clinical benefits of motor rehabilitation. These benefits are due in part to a facilitation of neuroplasticity caused by activating the auricular branch of the vagus nerve. This project takes this approach one step further, moving it into the home in combination with telerehabilitation in order to make this technology more accessible to individuals in rural and remote areas. In order to accomplish this, investigators will a) conduct lab-based testing and validation of the stimulation triggering sensors for at-home use, and b) determine the safety, feasibility, and acceptability of at-home taVNS in five stroke survivors with unilateral upper limb motor deficits. Investigators hypothesize that our lab-based validation will facilitate an optimized home intervention. Furthermore, investigators hypothesize taVNS will be safe and feasible to self-administer in the at-home setting. Lastly, investigation will help elucidate any challenges that may occur as investigators begin to expand this technology into future larger trials
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
Medical University of South Carolina
Charleston, South Carolina, United States
Number of Participants Dropped Out
Dropout rates will be assessed over the course of the study.
Time frame: 2 weeks
Adverse Events
Any side effects or adverse events will be assessed.
Time frame: 2 weeks
Mean Participant Compliance With Prescribed At-Home Sessions
Compliance defined as the percentage of prescribed at-home transcutaneous auricular vagus nerve stimulation (taVNS) paired with task-specific training sessions completed by each participant during the 2-week intervention (6 sessions per participant).
Time frame: 2 weeks
Feasibility of Independent Completion of At-Home Study Procedures
Feasibility was assessed during each remotely supervised at-home session using a 3-point assistance scale evaluating the participant's ability to independently complete study procedures at home. Ratings were assigned as follows: 1 = no assistance required, 2 = minimal assistance required, and 3 = maximum assistance required. Lower scores indicate greater participant independence and greater feasibility of at-home administration.
Time frame: 2 weeks
Percentage of Supervised At-Home Sessions Meeting Prespecified Feasibility Criteria
Feasibility was defined as the proportion of supervised at-home sessions that met both prespecified criteria: (1) completion of greater than 80% of prescribed motor rehabilitation activities and (2) receipt of at least 45 minutes of transcutaneous auricular vagus nerve stimulation during the session.
Time frame: 2 weeks
Motor Function- Fugl-Meyer Assessment
Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Fugl-Meyer Assessment (FMA).
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Time frame: 2 weeks
Motor Function- Wolf Motor Function
Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Wolf Motor Function Test.
Time frame: 2-weeks