Search / Trial NCT06616831

At-Home TaVNS - Stroke Rehab

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

Trial Information

Current as of October 08, 2024

Not yet recruiting

Keywords

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 pro...

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.

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