RECRUITING

At-Home taVNS - Stroke Rehab

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Conditions

StrokeStroke, IschemicStroke Hemorrhagic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-28
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06616831

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior;
  2. * Ability to give consent;
  3. * 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;
  4. * 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;
  5. * Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.
  1. * Other concomitant neurological disorders affecting upper extremity motor function;
  2. * Presence of Dysphagia or aspiration difficulties;
  3. * Prior injury to vagus nerve;
  4. * Pregnancy;
  5. * Documented history of dementia before or after stroke;
  6. * Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;
  7. * Uncontrolled hypertension;
  8. * Botox injections within 4 weeks of the first day of rehabilitation therapy.

Contacts and Locations

Study Contact

Katie Tucker
CONTACT
843-792-9502
tuckekat@musc.edu

Principal Investigator

Bashar Badran, PhD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29403
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Bashar Badran, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-28
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-10-28
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Stroke
  • Stroke, Ischemic
  • Stroke Hemorrhagic