Transcutaneous Electrical Stimulation for Stroke

Overseen By Mary Ellen Stoykov, PhD, OT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Pregnancy, Pacemaker, Cancer, TBI, others

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

Compensation: Varies

Number of Visits: 17

Duration: 6 weeks

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcutaneous electrical stimulation (TESS) can aid individuals with arm movement difficulties following a stroke. It compares the effects of actual spinal cord stimulation with a placebo version during arm exercises. Individuals who experienced a stroke at least six months ago, have difficulty moving an arm, and are not currently receiving occupational therapy may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance recovery options for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a pacemaker, defibrillator, or other implanted devices, you may not be eligible to participate.

What prior data suggests that transcutaneous electrical stimulation is safe for stroke recovery?

Research has shown that transcutaneous electrical stimulation (TESS) is generally safe. Studies have found it relieves pain and reduces the need for opioid painkillers without causing infections. Most patients tolerate it well, as the stimulation level can be adjusted for comfort. Some reports suggest it may not significantly improve arm movement after a stroke, but combining TESS with other treatments can help strengthen muscles and enhance movement. Overall, TESS is considered safe, though individual results may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stroke treatments, which often rely on physical therapy and medication to aid recovery, Transcutaneous Electrical Stimulation (TESS) offers a non-invasive method that directly stimulates the spinal cord. Researchers are excited about TESS because it uses electrical impulses delivered through electrodes placed on the skin to potentially enhance neural connections and improve motor function. This approach could lead to quicker recovery times and better outcomes for stroke patients by directly targeting and activating the neural pathways involved in movement.

What evidence suggests that transcutaneous electrical stimulation is effective for stroke recovery?

This trial will compare the effects of transcutaneous electrical stimulation (TESS) with a sham version in stroke patients. Studies have shown that TESS can help stroke patients regain muscle strength and improve movement. Research indicates that TESS, especially at high frequencies like 100 Hz, can significantly reduce muscle tightness and support movement recovery. One study found that applying TESS to the arms after a stroke led to better movement recovery. Additionally, TESS has proven helpful when combined with other rehabilitation methods, such as practicing specific tasks. Overall, these findings suggest that TESS could be a promising option for improving arm function in stroke survivors. Participants in this trial will receive either TESS during task-specific training or a sham version without real stimulation. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for stroke survivors with upper limb weakness, who can follow the study procedures. Specific details about eligibility are not provided, but typically participants must be stable post-stroke and without other medical conditions that could interfere with the study.

Inclusion Criteria

My arm function is significantly limited.

Able and willing to give written consent and comply with study procedures

Participant has received clearance from physician to participate in study

Exclusion Criteria

Pregnant or nursing

Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD), or anti-spasticity implantable pumps, or cochlear implants

Non-English speakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 15 sessions of either TESS plus task specific training or Sham TESS plus task specific training

6 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Stimulation

Trial Overview

The trial is testing if adding transcutaneous electrical spinal cord stimulation (TESS) to task-specific training helps improve arm function in stroke patients better than training with a sham (fake) TESS.

How Is the Trial Designed?

Group I: Experimental Group Active Control 2 Interventions

This group receives task specific training and transcutaneous spinal cord stimulation (TESS) during treatment sessions. TESS is applied via electrodes placed vertically over the spinous processes of C5-C6. The stimulation will be adjusted within a range of 10mA to 100mA based on participant tolerance and will be delivered for 30 minutes per training session.

Group II: Comparator Group Active Control 2 Interventions

This group receives task specific training without real TESS during treatment sessions. Instead, they receive Sham TESS, which is a placebo version in which the electrodes are applied and the stimulation is turned on so that the patient can feel it, and then ramped down to zero for the duration of the session.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

Low intensity transcranial electrical stimulation (TES) is considered safe, with no serious adverse events reported in over 18,000 sessions across various populations, including healthy individuals and patients with neurological or psychiatric conditions.

While moderate adverse events like skin burns from tDCS are rare, mild adverse events such as headaches and fatigue are more common, and the safety profile is consistent across different age groups and vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal, A., Alekseichuk, I., Bikson, M., et al.[2023]

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]

A systematic review of 75 studies on noninvasive electrical stimulation (ES) in stroke recovery found that adverse events were mostly minor, with tingling being the most common at 18.1% prevalence among participants.

While some adverse events like itching and discomfort were associated with specific stimulation parameters, the overall safety profile of ES appears favorable, with only two severe adverse events reported, indicating it can be a safe therapeutic option for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review. Turnbull, C., Boomsma, A., Milte, R., et al.[2023]

Transcranial electrical stimulation (tES), including tDCS and MHF-tPCS, was found to be well tolerated in healthy subjects over a six-week period, with common side effects being mild skin sensations like tingling and itching, which were less frequent than in the sham-tDCS group.

The MHF-tPCS group showed significantly higher compliance in completing sessions compared to the sham-tDCS group, indicating that this waveform may be more acceptable for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. Paneri, B., Adair, D., Thomas, C., et al.[2018]

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]

Therapeutic electrical stimulation (TES) shows a positive effect on improving motor control in stroke patients, with effect sizes ranging from 0.55 to 1.46 in three of the six randomized controlled trials reviewed.

The evidence regarding TES's impact on functional abilities is inconclusive, as only one of the two studies that assessed this outcome reported a positive effect, indicating that more research is needed in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic electrical stimulation to improve motor control and functional abilities of the upper extremity after stroke: a systematic review. de Kroon, JR., van der Lee, JH., IJzerman, MJ., et al.[2018]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8410308/

Effectiveness of Transcutaneous Electrical Nerve Stimulation ...

TENS combined with taping may be useful in improving spasticity, muscle strength, and gait ability in stroke patients.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0894113025000870

Effects of transcutaneous electrical nerve stimulation on ...

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TENS is effective in reducing spasticity and improving muscle strength and gait performance in stroke patients with lower limb dysfunction. A 100 Hz stimulation ...

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ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.121.036895

Bilateral Transcutaneous Electrical Nerve Stimulation ...

Conclusions: Bi-TENS combined with TOT is an effective therapy for improving upper limb motor recovery following stroke. Registration: URL ...

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jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01744-3

Superior efficacy of 100-Hz transcutaneous electrical nerve ...

Our findings reveal that high-frequency stimulation at 100 Hz yields more pronounced improvements in spasticity reduction and motor recovery ...

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sciencedirect.com

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Adding electrical stimulation during standard rehabilitation ...

Electrical sensory input can contribute to routine rehabilitation to improve early post-stroke lower-extremity impairment and late motor function.

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ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.123.043414

tVNS in Stroke: A Narrative Review on the Current State ...

Transcutaneous vagus nerve stimulation (tVNS) has shown promising evidence as a tool to reduce infarct size in animal models of hyperacute stroke.

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jhandtherapy.org

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Effects of transcutaneous electrical nerve stimulation on ...

Transcutaneous electrical nerve stimulation alone shows limited effectiveness for upper limb recovery post-stroke. Combined with ...