Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients

NCT06541015 | Recruiting FDA Device

• 1 other identifier: STU-2018-0431
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Single unilateral stroke with single lower limb hemiparesis

Outcome Measures

Primary Outcomes (3)

• Reflex Testing

  Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on reflexes in post-stroke individuals

  3 months

• Walking Testing

  Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on walking in post-stroke individuals

  3 months

• Adaptation Testing

  Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on adaptation pattern in post-stroke individuals

  3 months

Study Arms (1)

Post Stroke - individuals with history of single unilateral stroke (>6 months since onset)

EXPERIMENTAL

Individuals, aged 18-80, male or female, with a history of single unilateral stroke with subsequent lower limb hemiparesis on either side (\>6 months since onset)

Device: InTENSity 10 TENS Stimulator

Interventions

InTENSity 10 TENS Stimulator DEVICE

InTENSity 10 TENS stimulator is a portable electrotherapy device featuring Transcutaneous Electrical Nerve Stimulation (TENS) therapeutic device. The stimulator sends a gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of device are controlled by the buttons.

Post Stroke - individuals with history of single unilateral stroke (>6 months since onset)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of single unilateral stroke with subsequent lower limb hemiparesis on either side (\> 6 months since onset)
• Ability to walk as part of activities of daily living
• Age between 18 and 80

You may not qualify if:

• 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
• History of any neurological injury other than a single stroke
• Has received a Botox injection in the lower extremity within the last 4 months
• Any cognitive deficit that would prevent informed consent or ability to perform the experiment
• History of prior injury or surgery to the hip or knee
• 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)
• Weight greater than 300 pounds
• Adults unable to consent, infants, children, teenagers, pregnant women and prisoners will not be included in the study
• Clinically significant depression, psychiatric disorders, or ongoing drug abuse
• Actively taking medications with agents known to increase (e.g. amphetamines) or decrease motor system excitability
• Suffered a concussion in the last 6 months.
• Unexplained headaches
• Healthy Cohort:
• No history of stroke, cerebral palsy, injury or surgery to the lower limb.
• Currently not taking any central nervous system (CNS) affecting medication.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Study Officials

• Yasin Dhaher, Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: June 21, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)