Hemiplegia and/or Hemiparesis Following StrokeTENSNCT06541015
Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients
A study testing InTENSity 10 TENS Stimulator in people with Hemiplegia and/or Hemiparesis Following Stroke and Anterior Circulation Stroke of Uncertain Pathology, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia and/or Hemiparesis Following Stroke, Anterior Circulation Stroke of Uncertain Pathology
- What is being tested?
- InTENSity 10 TENS Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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)
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- 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Center
Dallas, Texas, 75390
Yasin Dhaher, Ph.D., 214-645-0064, yasin.dhaher@utsoutwestern.edu
Yu-Chen Chung, Ph.D., 214-648-8838, yu-chen.chung@utsouthwestern.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemiplegia and/or Hemiparesis Following Stroke, Anterior Circulation Stroke of Uncertain Pathology
- Being tested
- InTENSity 10 TENS Stimulator
- Keywords
- Single unilateral stroke with single lower limb hemiparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InTENSity 10 TENS StimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: InTENSity 10 TENS Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflex Testing
Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on reflexes in post-stroke individuals
Measured: 3 months
Walking Testing
Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on walking in post-stroke individuals
Measured: 3 months
Adaptation Testing
Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on adaptation pattern in post-stroke individuals
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start21 Jun 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia and/or Hemiparesis Following StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Dhaher, University of Texas Southwestern Medical Center
- Investigators
- Yasin Dhaher, Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541015
- Sponsor's protocol ID
- STU-2018-0431
- Acronym
- TENS
- Status last verified
- Feb 2026
- First submitted
- 2 Aug 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TENS (Transcutaneous Electrical Nerve Stimulation): Effect of Transcutaneous Spinal Direct Current Stimulation on Lower Limb Reflex, Volitional, and Functional Movement Post-stroke
- ClinicalTrials.gov ID
- NCT06541015
- Acronym / sponsor ID
- TENS / STU-2018-0431
- Conditions
- Hemiplegia and/or Hemiparesis Following Stroke, Anterior Circulation Stroke of Uncertain Pathology
- Keywords
- Single unilateral stroke with single lower limb hemiparesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post Stroke - individuals with history of single unilateral stroke (>6 months since onset) | Experimental | Device: InTENSity 10 TENS StimulatorIndividuals, 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- No history of stroke, cerebral palsy, injury or surgery to the lower limb.
- Currently not taking any central nervous system (CNS) affecting medication.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InTENSity 10 TENS StimulatorInTENSity 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. | Device | Post Stroke - individuals with history of single unilateral stroke (>6 months since onset) |
Primary outcome
Reflex Testing
Time frame: 3 months
Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on reflexes in post-stroke individuals
Walking Testing
Time frame: 3 months
Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on walking in post-stroke individuals
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasin Dhaher, Ph.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InTENSity 10 TENS Stimulator in people with Hemiplegia and/or Hemiparesis Following Stroke and Anterior Circulation Stroke of Uncertain Pathology, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasin Dhaher, Ph.D. (214-645-0064, yasin.dhaher@utsoutwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflex Testing (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.