COMPLETED

Neuromodulation and Dynamic Balance in Stroke

Conditions

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

Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training improves postural and walking stability post-stroke.

Official Title

Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors

Quick Facts

Study Start:2023-08-28
Study Completion:2025-07-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05135533

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:22 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least six months since the onset of Ischemic or hemorrhagic stroke.
  2. * Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score \< 34).
  3. * Are able to provide informed consent demonstrated by their ability to weigh the consequences of participating versus not participating in the study.
  4. * Can walk at least 10 feet with and without assistive device.
  5. * Functional Gait Assessment score \<22.
  1. * Pre-existing neurological disorders.
  2. * Previous stroke affecting the other hemisphere .
  3. * Severe arthritis or orthopedic problems that limit passive range of motion.
  4. * Areas of recent bleeding or open wounds.
  5. * Lack normal sensation on the tongue.
  6. * Received treatment for cancer within the past year.
  7. * Non-removable metal orthodontic devices.
  8. * Oral health problems.
  9. * Are sensitive to nickel, gold or copper.
  10. * Chronic infectious diseases.
  11. * Are pregnant.
  12. * Have dementia

Contacts and Locations

Principal Investigator

Steven Kautz, PhD
STUDY_CHAIR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Steven Kautz, PhD, STUDY_CHAIR, 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 Date2023-08-28
Study Completion Date2025-07-24

Study Record Updates

Study Start Date2023-08-28
Study Completion Date2025-07-24

Terms related to this study

Additional Relevant MeSH Terms

  • Stroke