TENS for Stroke

(TENS Trial)

Overseen By Yu-Chen Chung, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Amphetamines, CNS affecting, others

Disqualifiers: Neurological injury, Diabetes, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 4 months

100 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{8 10 11 12 13}

Who Is on the Research Team?

Yasin Dhaher, Ph.D.

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Post Stroke - individuals with history of single unilateral stroke (>6 months since onset) Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Transcutaneous electrical nerve stimulation (TENS) therapy significantly reduced shoulder pain and improved upper extremity function in hemiplegic patients compared to a placebo, with notable improvements in pain scores (VAS) and daily life activities (Barthel Index).

TENS therapy also led to significant enhancements in shoulder passive range of motion, specifically in abduction and external rotation, indicating its effectiveness as an adjunct to conventional rehabilitation for managing hemiplegic shoulder pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency of TENS treatment in hemiplegic shoulder pain: a placebo controlled study]. Ekim, A., Armağan, O., Oner, C.[2016]

Transcutaneous electrical nerve stimulation (TENS) significantly reduces chronic post-stroke spasticity compared to placebo, with a notable effect size of -0.52 on the Modified Ashworth Scale, based on a systematic review of 10 studies involving 360 subjects.

TENS is particularly effective for spasticity in the lower limbs and can be used as an additional therapy alongside physical interventions, although both high and low frequency TENS showed similar efficacy, indicating further research is needed to optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Marcolino, MAZ., Hauck, M., Stein, C., et al.[2021]

In a study involving 24 healthy university students, TENS at 5 Hz applied to the soleus muscle significantly improved popliteal flow volume compared to lower frequency applications, suggesting it may be the most effective protocol for enhancing venous return.

While all TENS applications produced notable hemodynamic responses, the 5 Hz stimulation on the peroneal nerve was the least tolerated by participants, indicating a trade-off between efficacy and comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical nerve stimulation via peroneal nerve or soleus muscle on venous flow: A randomized cross-over study in healthy subjects. Martínez-Rodríguez, A., Senin-Camargo, F., Raposo-Vidal, I., et al.[2022]

In a three-year follow-up study of 28 stroke patients, low-frequency transcutaneous electrical nerve stimulation (low TENS) did not lead to long-term improvements in arm motor function, as both treatment and control groups experienced deterioration in motor function over time.

However, the low TENS group maintained their activities of daily living (ADL) scores, while the control group showed a decline, suggesting that low TENS may help preserve daily functioning despite not improving motor recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low TENS treatment on post-stroke paretic arm: a three-year follow-up. Sonde, L., Kalimo, H., Fernaeus, SE., et al.[2017]

In a pilot study involving 10 subjects with hemiplegic shoulder pain, neither transcutaneous electrical nerve stimulation (TENS) nor transcutaneous neuromuscular electrical stimulation (t-NMES) showed a significant acute effect on improving pain-free range of motion during shoulder movements.

The variability in pain-free range of motion was largely due to differences between subjects rather than the type of electrical stimulation used, indicating that TENS and t-NMES may not provide immediate pain relief in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of electrical stimulation on impairment of the painful post-stroke shoulder. Whitehair, VC., Chae, J., Hisel, T., et al.[2020]

In a study of 102 women using transcutaneous electric nerve stimulation (TNS) during delivery, over half (55.9%) reported good to very good pain relief, indicating its efficacy as a pain management technique.

TNS was found to have no adverse effects on either the mother or fetus, and it contributed to a quicker delivery without obstetrical complications, supporting its designation as a safe and effective method for pain relief during childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of transcutaneous nerve stimulation on labor pain (author's transl)]. Kubista, E., Kucera, H., Riss, P.[2011]

A proposed safety standard for current density in transcutaneous electrical nerve stimulation (TNS) is set at 0.5 microamperemeter/mm2 to ensure safety for the fetal heart during stimulation near vital structures.

In a study involving 15 supervised births, TNS applied to the low-back and suprapubic region showed no adverse effects on mothers or newborns, indicating the safety of the tested equipment and methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain relief in labor by transcutaneous electrical nerve stimulation. Safety aspects. Bundsen, P., Ericson, K.[2019]

Transcutaneous electrical nerve stimulation (TENS) is a noninvasive and easy-to-use therapy that may promote tissue repair, including wound healing and tendon repair, by increasing blood flow through the release of specific neuropeptides.

Despite the potential benefits suggested by 30 articles reviewed, the evidence remains inconclusive due to insufficient data from randomized controlled trials to definitively confirm the efficacy of TENS in tissue repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of transcutaneous electrical nerve stimulation on tissue repair: A literature review. Machado, AF., Santana, EF., Tacani, PM., et al.[2022]

In a study involving 38 stroke patients with hemiplegic shoulder pain, EMG-triggered neuromuscular electrical stimulation (NMES) combined with bilateral arm training resulted in significantly lower pain intensity and improved shoulder mobility compared to transcutaneous electrical nerve stimulation (TENS) after 4 weeks of treatment.

Both NMES and TENS led to improvements in pain and arm function, but NMES showed greater long-term benefits in reducing pain during movement and enhancing pain-free shoulder range of motion, indicating it may be a more effective intervention for managing shoulder pain in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm function after stroke: a randomized controlled trial. Chuang, LL., Chen, YL., Chen, CC., et al.[2018]

A systematic review included 12 randomized controlled trials with 919 participants to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for treating acute pain, but insufficient data prevented definitive conclusions.

The review highlighted that many studies were excluded because TENS was used alongside other treatments, indicating a need for more focused research on TENS as a standalone therapy for acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. Walsh, DM., Howe, TE., Johnson, MI., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Bilateral Transcutaneous Electrical Nerve Stimulation Improves Lower-Limb Motor Function in Subjects With Chronic Stroke: A Randomized Controlled Trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The effects of exercise with TENS on spasticity, balance, and gait in patients with chronic stroke: a randomized controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation improves walking capacity and reduces spasticity in stroke survivors: a systematic review and meta-analysis. [2019]

4. Turkey pubmed.ncbi.nlm.nih.gov

[Efficiency of TENS treatment in hemiplegic shoulder pain: a placebo controlled study]. [2016]

5. England pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical nerve stimulation via peroneal nerve or soleus muscle on venous flow: A randomized cross-over study in healthy subjects. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Low TENS treatment on post-stroke paretic arm: a three-year follow-up. [2017]

8. England pubmed.ncbi.nlm.nih.gov

The effect of electrical stimulation on impairment of the painful post-stroke shoulder. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

[The effect of transcutaneous nerve stimulation on labor pain (author's transl)]. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

Pain relief in labor by transcutaneous electrical nerve stimulation. Safety aspects. [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

The effects of transcutaneous electrical nerve stimulation on tissue repair: A literature review. [2022]

12. England pubmed.ncbi.nlm.nih.gov

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]

13. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. [2022]