Recruiting

Transcutaneous Electrical Nerve Stimulation

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06541015

Conditions

Hemiplegia and/or Hemiparesis Following Stroke

Anterior Circulation Stroke of Uncertain Pathology

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

InTENSity 10 TENS Stimulator

Study Details

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

Hemiplegia and/or Hemiparesis Following Stroke

Anterior Circulation Stroke of Uncertain Pathology

Study ID

NCT06541015

Start date

Jun 21, 2019

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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)

Interventions

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.

Primary outcome measure

  • Reflex Testing [ Time Frame: 3 months ]
  • Walking Testing [ Time Frame: 3 months ]
  • Adaptation Testing [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Yasin Dhaher, Ph.D.

214-645-0064yasin.dhaher@utsoutwestern.edu

Yu-Chen Chung, Ph.D.

214-648-8838yu-chen.chung@utsouthwestern.edu

Locations

University of Texas Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Yasin Dhaher, Ph.D.

214-645-0064yasin.dhaher@utsoutwestern.edu

Yu-Chen Chung, Ph.D.

214-648-8838yu-chen.chung@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Mar 30, 2026

Last verified

Feb, 2026

Keywords

  • Single unilateral stroke with single lower limb hemiparesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-03-30.