At-Home taVNS - Stroke Rehab
- Conditions
- StrokeStroke, IschemicStroke Hemorrhagic
- Interventions
- Device: Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training
- Registration Number
- NCT06616831
- Lead Sponsor
- Medical University of South Carolina
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training 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.
- Primary Outcome Measures
Name Time Method Subjective ratings of feasibility. 2 weeks Feasibility will be assessed with subjective ratings on subject's ability to complete study procedures at home.
Feasibility through dropout rates 2 weeks Dropout rates will be assessed over the course of the study.
Safety of stimulation 2 weeks Any side effects or adverse events will be assessed.
Compliance 2 weeks Compliance with study procedures will be assessed every study visit.
- Secondary Outcome Measures
Name Time Method Motor Function 2 weeks Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Fugl-Meyer Assessment (FMA).
Compliance with at-home sessions 2 weeks The total number of completed at-home sessions will be measured. The total stimulation duration completed within each session. Benchmarks of \>80% total motor rehabilitation sessions completed, and 45 minute in-session duration will be the feasibility cutoffs for the analysis.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States