Using electrical stimulation to help stroke patients with leg movement
Official title: TENS (Transcutaneous Electrical Nerve Stimulation): Effect of Transcutaneous Spinal Direct Current Stimulation on Lower Limb Reflex, Volitional, and Functional Movement Post-stroke
Run by University of Texas Southwestern Medical Center · NCT06541015 · Data updated 2026-11-12
This study tests if using electrical stimulation can help stroke patients improve their leg movement and mobility.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | June 21, 2019 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT06541015 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 who have experienced a single unilateral stroke more than six months ago and can walk as part of daily activities.
✕Probably not a fit
Patients with severe concurrent medical conditions, cognitive deficits, or recent Botox injections in the lower extremity may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of transcutaneous electrical nerve stimulation (TENS) on patients who have experienced a stroke resulting in hemiparesis. Participants will attend a minimum of 15 sessions over four months, where they will undergo various tests to assess reflex behaviors, motor tract influences, and functional movement adaptations. The study aims to collect and analyze data to evaluate the efficacy of TENS in improving mobility and motor function in post-stroke patients.
Why it matters
Potential benefit: If successful, this approach could enhance mobility and functional recovery for stroke patients with lower limb hemiparesis.
How similar studies have gone: While the use of electrical stimulation in rehabilitation is not entirely novel, the specific application of TENS for this patient population is less explored, making this study a potentially significant contribution to the field.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
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University of Texas Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Yasin Dhaher, Ph.D. — University of Texas Southwestern Medical Center
- Study coordinator: Yasin Dhaher, Ph.D.
- Email: yasin.dhaher@utsoutwestern.edu
- Phone: 214-645-0064
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.