TENS for Stroke
(TENS Trial)
Trial Summary
Will I have to stop taking my current medications?
If you are actively taking medications that affect the central nervous system or those that increase or decrease motor system excitability, you may need to stop them to participate in the trial. The protocol does not specify a washout period, but these medications are part of the exclusion criteria.
What data supports the effectiveness of the treatment Transcutaneous Electrical Nerve Stimulation (TENS) for stroke?
Is TENS generally safe for humans?
How is the TENS treatment different from other treatments for stroke?
TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it is a non-drug, non-invasive treatment that uses low-frequency electrical currents applied through the skin to help reduce pain and improve motor function after a stroke. Unlike other treatments, it is easy to use, inexpensive, and can be combined with exercise to enhance recovery.12111213
What is the purpose of this trial?
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.
Research Team
Yasin Dhaher, Ph.D.
Principal Investigator
University of Texas Southwestern Medical Center
Eligibility Criteria
This trial is for post-stroke patients who have hemiplegia or paresis, which means they've lost some muscle control on one side of their body. Participants should be able to commit to at least 15 sessions over four months.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo 15 sessions for testing changes in reflex behaviors, influence of descending motor tracts, and functional movement
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Extension
Additional sessions for completing data collection or analyzing test-retest variability
Treatment Details
Interventions
- Transcutaneous Electrical Nerve Stimulation
Transcutaneous Electrical Nerve Stimulation is already approved in United States, European Union, Canada for the following indications:
- Pain management
- Musculoskeletal pain
- Neck pain
- Back pain
- Knee osteoarthritis pain
- Overactive bladder
- Urinary retention
- Temporomandibular joint dysfunction
- Essential tremor
- Pain management
- Musculoskeletal pain
- Neck pain
- Back pain
- Knee osteoarthritis pain
- Overactive bladder
- Urinary retention
- Temporomandibular joint dysfunction
- Essential tremor
- Pain management
- Musculoskeletal pain
- Neck pain
- Back pain
- Knee osteoarthritis pain
- Overactive bladder
- Urinary retention
- Temporomandibular joint dysfunction
- Essential tremor
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor