Search / Trial NCT06616831

At-Home taVNS - Stroke Rehab

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Sep 25, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called "At-Home taVNS - Stroke Rehab," is exploring a new way to help people recover from strokes. Researchers believe that using electrical stimulation on the ear might improve rehabilitation for stroke survivors who have trouble using their arms. The study aims to see how effective this method is when combined with motor rehabilitation exercises that patients can do at home.

To participate in this trial, you need to be between 18 and 80 years old and have had a stroke at least six months ago, either from a blockage (ischemic) or bleeding (hemorrhagic). It's important that you have some movement in your affected arm, as this will help you engage in rehabilitation tasks. Participants can expect to receive ear stimulation while working on exercises to improve their arm strength and function. If you have other serious health issues that affect your arm movement, difficulties swallowing, or a history of certain mental health conditions, you may not be eligible for this study. Overall, this trial could offer a promising new approach to stroke recovery at home.

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Bashar Badran, PhD

Principal Investigator

Medical University of South Carolina

About Medical University Of South Carolina

The Medical University of South Carolina (MUSC) is a leading academic health center dedicated to advancing medical research and improving patient care through innovative clinical trials. With a strong emphasis on translational medicine, MUSC leverages its extensive resources and expertise to facilitate groundbreaking studies across various medical disciplines. The institution is committed to fostering collaboration among researchers, healthcare professionals, and patients, ensuring that cutting-edge discoveries translate into effective treatments. As a pioneer in health education and research, MUSC plays a vital role in shaping the future of medicine and enhancing health outcomes in the community and beyond.

Locations

Charleston, South Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0