RECRUITING

Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients

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

The subjects will be asked to attend minimum 15 separate sessions, 6 for testing changes in reflex behaviors, 3 for testing changes in the influence of descending motor tracts on spinal motor neurons, 3 for each testing functional movement in response to a trip event and cross-tilt walking adaptation pattern, as part of their participation in the research study. The estimated amount of time to enroll and collect the data for each of the subjects is four months' time. The data will be analyzed and ready for grant preparation (if successful) in approximately four months after the start of the study.

Official Title

TENS (Transcutaneous Electrical Nerve Stimulation): Effect of Transcutaneous Spinal Direct Current Stimulation on Lower Limb Reflex, Volitional, and Functional Movement Post-stroke

Quick Facts

Study Start:2019-06-21
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06541015

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of single unilateral stroke with subsequent lower limb hemiparesis on either side (\> 6 months since onset)
  2. * Ability to walk as part of activities of daily living
  3. * Age between 18 and 80
  1. * Presence of concurrent severe medical illness including unhealed pressure sore, active or untreated infection, thromboembolic disease, severe contracture, osteoporosis, heterotropic classification, lower limb fracture, severe pulmonary disease or cardiovascular instability, uncontrolled seizure, uncontrolled diabetes
  2. * History of any neurological injury other than a single stroke
  3. * Has received a Botox injection in the lower extremity within the last 4 months
  4. * Any cognitive deficit that would prevent informed consent or ability to perform the experiment
  5. * History of prior injury or surgery to the hip or knee
  6. * Presence of significant lower extremity edema - Presence of cardiac pacemaker or any other electrically implanted device - Use of braces limiting harness/Lokomat fit (Any spinal orthoses such as TLSO, HALO)
  7. * Weight greater than 300 pounds
  8. * Adults unable to consent, infants, children, teenagers, pregnant women and prisoners will not be included in the study
  9. * Clinically significant depression, psychiatric disorders, or ongoing drug abuse
  10. * Actively taking medications with agents known to increase (e.g. amphetamines) or decrease motor system excitability
  11. * Suffered a concussion in the last 6 months.
  12. * Unexplained headaches

Contacts and Locations

Study Contact

Yasin Dhaher, Ph.D.
CONTACT
214-645-0064
yasin.dhaher@utsoutwestern.edu
Yu-Chen Chung, Ph.D.
CONTACT
214-648-8838
yu-chen.chung@utsouthwestern.edu

Principal Investigator

Yasin Dhaher, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center

Study Locations (Sites)

University of Texas Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Yasin Dhaher, Ph.D., PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

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 Date2019-06-21
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-06-21
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Single unilateral stroke with single lower limb hemiparesis

Additional Relevant MeSH Terms

  • Hemiplegia and/or Hemiparesis Following Stroke
  • Anterior Circulation Stroke of Uncertain Pathology