RecruitingNot ApplicableNCT06616831

At-Home taVNS - Stroke Rehab

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


Sponsor

Medical University of South Carolina

Enrollment

5 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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.

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Interventions

DEVICERemote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training

Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06616831


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