Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients (TENS)

March 25, 2026 updated by: Yasin Dhaher, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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. During the first session, the subjects will be screened and informed about the research study, so they can consent to their participation. They will also be oriented to the lab, the equipment, as well as the research team. Following the orientation, the remaining time will consist of approximately 3 hours of data collection. The remaining will last approximately 3 hours and consist of the completion of data collection. Additional sessions after 15 sessions will be optional and will be reserved for completing data collection if the subject is unable to complete a trial session or to analyze for test retest variability within the subject population. 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Post Stroke Cohort:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

Inclusion Criteria:

  • No history of stroke, cerebral palsy, injury or surgery to the lower limb.
  • Currently not taking any central nervous system (CNS) affecting medication.
  • Ability to walk as part of activities of daily living
  • Age between 18 and 80

Exclusion Criteria:

  • 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
  • Taking any medication affecting change in CNS
  • 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
  • Has received a Botox injection in the lower extremity within the last 4 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post Stroke - individuals with history of single unilateral stroke (>6 months since onset)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reflex Testing
Time Frame: 3 months
Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on reflexes in post-stroke individuals
3 months
Walking Testing
Time Frame: 3 months
Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on walking in post-stroke individuals
3 months
Adaptation Testing
Time Frame: 3 months
Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on adaptation pattern in post-stroke individuals
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Yasin Dhaher, Ph.D., 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 Major Dates

Study Start (Actual)

June 21, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2018-0431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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