14 Participants Needed

Transcutaneous Electrical Stimulation for Stroke

ME
Overseen ByMary Ellen Stoykov, PhD, OT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Shirley Ryan AbilityLab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.1241112

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
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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
See 9 more

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
2Treatment groups
Active Control
Group I: Experimental GroupActive Control2 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 GroupActive Control2 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.

Find a Clinic Near You

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.
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.
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.
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]

References

Bilateral Transcutaneous Electrical Nerve Stimulation Improves Lower-Limb Motor Function in Subjects With Chronic Stroke: A Randomized Controlled Trial. [2019]
Transcutaneous electrical nerve stimulation improves walking capacity and reduces spasticity in stroke survivors: a systematic review and meta-analysis. [2019]
Transcutaneous electrical nerve stimulation combined with task-related training improves lower limb functions in subjects with chronic stroke. [2016]
The effects of exercise with TENS on spasticity, balance, and gait in patients with chronic stroke: a randomized controlled trial. [2021]
Accelerometer-triggered electrical stimulation for reach and grasp in chronic stroke patients: a pilot study. [2022]
Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review. [2023]
Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. [2018]
Repetitive epileptic fits--a possible adverse effect after transcutaneous electrical nerve stimulation (TENS) in a post-stroke patient. [2019]
Rapid, Dose-Dependent Enhancement of Cerebral Blood Flow by transcranial AC Stimulation in Mouse. [2022]
Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]
Electrodes for high-definition transcutaneous DC stimulation for applications in drug delivery and electrotherapy, including tDCS. [2022]
Therapeutic electrical stimulation to improve motor control and functional abilities of the upper extremity after stroke: a systematic review. [2018]
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