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

Trial Summary

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 data supports the effectiveness of the treatment Transcutaneous Electrical Stimulation for stroke?

Research shows that transcutaneous electrical nerve stimulation (TENS) can improve walking ability and reduce muscle tightness in stroke survivors. It also enhances lower limb motor function when combined with task-related training, suggesting it may help improve movement in people who have had a stroke. ^{1 2 3 4 5}

Is transcutaneous electrical stimulation safe for humans?

Transcutaneous electrical stimulation is generally considered safe for humans, with no serious adverse events reported in over 18,000 sessions. Mild side effects like headaches and skin sensations are possible, and rare cases of epileptic fits have been noted in post-stroke patients. ^{6 7 8 9 10}

How does transcutaneous electrical stimulation differ from other stroke treatments?

Transcutaneous electrical stimulation (TES) is unique because it uses electrical currents applied through the skin to improve motor control and reduce spasticity in stroke patients, unlike traditional therapies that may rely on medication or physical therapy alone. This non-invasive approach can enhance motor function and walking capacity by directly stimulating nerves and muscles. ^{1 2 4 11 12}

What is the purpose of this trial?

This study aims to evaluate the feasibility and impact of transcutaneous electrical stimulation of the spinal cord (TESS) on the recovery of post-stroke individuals who have upper limb hemiparesis. It will compare outcomes measures between individuals who receive upper limb task specific training with TESS and individuals who receive task specific training of the upper limb with Sham, or fake, TESS.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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.

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]

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]

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]

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]

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]

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]

References

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. 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]

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

Transcutaneous electrical nerve stimulation combined with task-related training improves lower limb functions in subjects with chronic stroke. [2016]

4. 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]

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

Accelerometer-triggered electrical stimulation for reach and grasp in chronic stroke patients: a pilot study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review. [2023]

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

Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. [2018]

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

Repetitive epileptic fits--a possible adverse effect after transcutaneous electrical nerve stimulation (TENS) in a post-stroke patient. [2019]

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

Rapid, Dose-Dependent Enhancement of Cerebral Blood Flow by transcranial AC Stimulation in Mouse. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Electrodes for high-definition transcutaneous DC stimulation for applications in drug delivery and electrotherapy, including tDCS. [2022]

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

Therapeutic electrical stimulation to improve motor control and functional abilities of the upper extremity after stroke: a systematic review. [2018]