100 Participants Needed

TENS for Stroke

(TENS Trial)

YD
YC
Overseen ByYu-Chen Chung, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that TENS can help improve motor function, reduce muscle stiffness (spasticity), and enhance walking ability in stroke survivors. It is particularly effective when combined with physical exercises.12345

Is TENS generally safe for humans?

Research shows that TENS is generally safe for humans, with no side effects noted in studies involving childbirth and no adverse effects observed in mothers or newborns. However, it's important to use the correct settings to avoid any potential harm, especially near vital areas.678910

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

YD

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

* 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 session
1 visit (in-person)

Treatment

Participants undergo 15 sessions for testing changes in reflex behaviors, influence of descending motor tracts, and functional movement

4 months
15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Extension

Additional sessions for completing data collection or analyzing test-retest variability

Treatment Details

Interventions

  • Transcutaneous Electrical Nerve Stimulation
Trial Overview The study tests the effects of a Transcutaneous Electrical Nerve Stimulation (TENS) device called InTENSity 10 on stroke recovery. It involves various tests to see how it affects reflexes, motor neuron activity, and walking patterns after a stroke.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Post Stroke - individuals with history of single unilateral stroke (>6 months since onset)Experimental Treatment1 Intervention
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)

Transcutaneous Electrical Nerve Stimulation is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as TENS for:
  • Pain management
  • Musculoskeletal pain
  • Neck pain
  • Back pain
  • Knee osteoarthritis pain
  • Overactive bladder
  • Urinary retention
  • Temporomandibular joint dysfunction
  • Essential tremor
🇪🇺
Approved in European Union as TENS for:
  • Pain management
  • Musculoskeletal pain
  • Neck pain
  • Back pain
  • Knee osteoarthritis pain
  • Overactive bladder
  • Urinary retention
  • Temporomandibular joint dysfunction
  • Essential tremor
🇨🇦
Approved in Canada as TENS for:
  • 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

Trials
1,102
Recruited
1,077,000+

Findings from Research

In a study of 80 chronic stroke patients, bilateral TENS combined with task-oriented training (TOT) significantly improved ankle dorsiflexion strength and reduced completion time for the Timed Up and Go test compared to unilateral TENS combined with TOT after 20 training sessions.
The results suggest that using bilateral TENS may enhance motor function recovery in stroke patients, particularly in improving specific lower-limb strength and mobility outcomes.
Bilateral Transcutaneous Electrical Nerve Stimulation Improves Lower-Limb Motor Function in Subjects With Chronic Stroke: A Randomized Controlled Trial.Kwong, PWH., Ng, GYF., Chung, RCK., et al.[2019]
In a study involving 34 chronic stroke patients, the addition of transcutaneous electrical nerve stimulation (TENS) to a therapeutic exercise program significantly reduced spasticity and improved balance and gait compared to a placebo group.
The TENS group showed notable improvements in various measures, including a 0.80 point reduction in spasticity, enhanced static and dynamic balance, and increased gait speed and cadence, indicating that TENS can be an effective adjunct therapy for stroke rehabilitation.
The effects of exercise with TENS on spasticity, balance, and gait in patients with chronic stroke: a randomized controlled trial.Park, J., Seo, D., Choi, W., et al.[2021]
Transcutaneous electrical nerve stimulation (TENS) significantly improves walking capacity and reduces spasticity in stroke survivors, based on a meta-analysis of 11 studies involving 439 participants.
Longer TENS sessions (60 minutes) are more effective for enhancing motor recovery compared to shorter sessions (20 or 30 minutes), indicating that session duration is an important factor in treatment efficacy.
Transcutaneous electrical nerve stimulation improves walking capacity and reduces spasticity in stroke survivors: a systematic review and meta-analysis.Kwong, PW., Ng, GY., Chung, RC., et al.[2019]

References

Bilateral Transcutaneous Electrical Nerve Stimulation Improves Lower-Limb Motor Function in Subjects With Chronic Stroke: A Randomized Controlled Trial. [2019]
The effects of exercise with TENS on spasticity, balance, and gait in patients with chronic stroke: a randomized controlled trial. [2021]
Transcutaneous electrical nerve stimulation improves walking capacity and reduces spasticity in stroke survivors: a systematic review and meta-analysis. [2019]
[Efficiency of TENS treatment in hemiplegic shoulder pain: a placebo controlled study]. [2016]
Effects of transcutaneous electrical nerve stimulation alone or as additional therapy on chronic post-stroke spasticity: systematic review and meta-analysis of randomized controlled trials. [2021]
Effects of transcutaneous electrical nerve stimulation via peroneal nerve or soleus muscle on venous flow: A randomized cross-over study in healthy subjects. [2022]
Low TENS treatment on post-stroke paretic arm: a three-year follow-up. [2017]
The effect of electrical stimulation on impairment of the painful post-stroke shoulder. [2020]
[The effect of transcutaneous nerve stimulation on labor pain (author's transl)]. [2011]
10.United Statespubmed.ncbi.nlm.nih.gov
Pain relief in labor by transcutaneous electrical nerve stimulation. Safety aspects. [2019]
The effects of transcutaneous electrical nerve stimulation on tissue repair: A literature review. [2022]
Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm function after stroke: a randomized controlled trial. [2018]
Transcutaneous electrical nerve stimulation for acute pain. [2022]
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