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Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06541015
Acronym
TENS
Enrollment
100
Registered
2024-08-07
Start date
2019-06-21
Completion date
2026-12-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Single unilateral stroke with single lower limb hemiparesis

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.

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.

Interventions

DEVICEInTENSity 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.

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Reflex Testing3 monthsTest if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on reflexes in post-stroke individuals
Walking Testing3 monthsTest if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on walking in post-stroke individuals
Adaptation Testing3 monthsTest if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on adaptation pattern in post-stroke individuals

Countries

United States

Contacts

CONTACTYasin Dhaher, Ph.D.
yasin.dhaher@utsoutwestern.edu214-645-0064
CONTACTYu-Chen Chung, Ph.D.
yu-chen.chung@utsouthwestern.edu214-648-8838
PRINCIPAL_INVESTIGATORYasin Dhaher, Ph.D.

University of Texas Southwestern Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026