At-Home taVNS - Stroke Rehab
Development of At-Home Transcutaneous Auricular Vagus Nerve Stimulation for Post-Stroke Rehabilitation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29403
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Other concomitant neurological disorders affecting upper extremity motor function;
- Presence of Dysphagia or aspiration difficulties;
- Prior injury to vagus nerve;
- Pregnancy;
- Documented history of dementia before or after stroke;
- Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;
- Uncontrolled hypertension;
- Botox injections within 4 weeks of the first day of rehabilitation therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Dropped Out
Time Frame: 2 weeks
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Dropout rates will be assessed over the course of the study.
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2 weeks
|
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Adverse Events
Time Frame: 2 weeks
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Any side effects or adverse events will be assessed.
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2 weeks
|
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Mean Participant Compliance With Prescribed At-Home Sessions
Time Frame: 2 weeks
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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).
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2 weeks
|
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Feasibility of Independent Completion of At-Home Study Procedures
Time Frame: 2 weeks
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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.
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Supervised At-Home Sessions Meeting Prespecified Feasibility Criteria
Time Frame: 2 weeks
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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.
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2 weeks
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Motor Function- Fugl-Meyer Assessment
Time Frame: 2 weeks
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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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2 weeks
|
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Motor Function- Wolf Motor Function
Time Frame: 2-weeks
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Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Wolf Motor Function Test.
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2-weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bashar Badran, PhD, Medical University of South Carolina
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00137256
- 3P20GM109040-10W2 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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