Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06616831

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

Led by Medical University of South Carolina · Updated on 2025-05-20

5

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Medical University of South Carolina

Lead Sponsor

N

National Institute of General Medical Sciences (NIGMS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring the use of transcutaneous auricular vagus nerve stimulation (taVNS) combined with motor rehabilitation to improve upper limb function after stroke. Early studies suggest that applying electrical stimulation to the ear during motor rehabilitation may double the benefits by enhancing brain plasticity. This trial aims to test this innovative approach in a home setting, making the treatment more accessible, especially for those living in rural or remote areas. Participants will receive task-specific training paired with EMG-activated taVNS three times a week for two weeks at home. Before this home intervention, lab-based testing will validate the stimulation sensors to ensure they work properly for at-home use. The study focuses on assessing the safety, feasibility, and acceptability of self-administered taVNS for stroke survivors with unilateral upper limb weakness. During the study, researchers will monitor dropout rates, safety of stimulation, and compliance over the two-week period. Participants' subjective ratings of feasibility and motor function improvements will also be evaluated. The trial involves regular assessments to determine how well participants can follow the treatment plan and will help identify any challenges to expanding this technology in future larger trials.

CONDITIONS

Brief Title

At-Home taVNS - Stroke Rehab

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Ischemic or hemorrhagic stroke occurred 6 months or more ago
  • Ability to give informed consent
  • Unilateral limb weakness with Fugl Meyer-Upper Extremity Scale score between 19 and 53
  • Active wrist flexion/extension of at least 10 degrees
  • Active abduction/extension of thumb and at least one digit by at least 10 degrees
  • Passive range of motion in affected shoulder, elbow, and wrist within 20 degrees of normal values
Not Eligible

You will not qualify if you...

  • Other neurological disorders affecting upper extremity motor function
  • Presence of dysphagia or aspiration difficulties
  • Prior injury to the vagus nerve
  • Pregnancy
  • History of dementia before or after stroke
  • History of uncontrolled depression or psychiatric disorder before or after stroke
  • Uncontrolled hypertension
  • Botox injections within 4 weeks before starting rehabilitation therapy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 2 weeks

Participants complete task-specific training paired with transcutaneous auricular vagal nerve stimulation at home.

3 visits per week for 2 weeks (remote sessions)

Trial Site Locations

Total: 1 location

1

Medical University of South Carolina

Charleston, South Carolina, United States, 29403

Actively Recruiting

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Research Team

K

Katie Tucker

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study.

Bashar W Badran, Xiaolong Peng, Brenna Baker-Vogel...

https://pubmed.ncbi.nlm.nih.gov/37209010