Electrical Stimulation for Stroke

Overseen By Shengai Li, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Tone alternating medications

Disqualifiers: Visual deficit, Pulmonary disease, Pacemaker, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Breathing-controlled electrical stimulation (BreEStim) to help stroke survivors improve hand function and reduce finger muscle tightness. It compares BreEStim to another type of electrical stimulation called EStim. Suitable participants have experienced a single stroke over 6 months ago and have noticeable finger muscle stiffness. The trial aims to determine if controlling the electrical treatment with breathing can impact recovery. As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery options for stroke survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently adjusting medications that affect muscle tone, like baclofen.

What prior data suggests that this electrical stimulation technique is safe for stroke patients?

Research has shown that Breathing-controlled electrical stimulation (BreEStim) effectively manages nerve pain and muscle tightness after a stroke, with no serious side effects reported. For transcutaneous electrical nerve stimulation (EStim), research indicates it can reduce muscle stiffness and increase muscle strength in stroke patients. Studies have not identified any major safety concerns, suggesting it is generally safe. Overall, both BreEStim and EStim have been tested in various settings without major safety issues, making them promising options for those considering joining clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

BreEStim is unique because it combines voluntary breathing with transcutaneous electrical nerve stimulation (TENS). Unlike traditional TENS treatments for stroke, which generally involve electrical stimulation alone, BreEStim adds a breathing component that researchers believe could enhance neuroplasticity and improve recovery outcomes. This innovative approach could potentially offer faster or more effective rehabilitation by engaging both the nervous and respiratory systems. Researchers are excited because this method could lead to improved motor function and recovery in stroke patients, offering a new dimension to stroke rehabilitation strategies.

What evidence suggests that BreEStim is effective for reducing finger flexor spasticity and improving hand function in chronic stroke?

In this trial, participants will join one of two treatment arms. Research has shown that Breathing-controlled Electrical Stimulation (BreEStim) may help treat muscle stiffness after a stroke. This method combines electrical nerve stimulation with controlled breathing to manage stiffness and improve hand function. Studies suggest that BreEStim effectively reduces stiffness and eases nerve pain.

For the other arm, Transcutaneous Electrical Nerve Stimulation (EStim), research has shown it can reduce stiffness and strengthen muscles in stroke patients, particularly in the legs. Some studies have noted improvements in muscle strength and movement with EStim. Both treatments have the potential to aid stroke recovery by reducing muscle stiffness and improving function. ^{1 2 6 7 8}

Who Is on the Research Team?

Sheng Li, MD, PhD

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke at least 6 months ago, are medically stable, and have some muscle stiffness in their fingers. They must not be pregnant or adjusting medications for muscle tone, and cannot have visual, hearing or cognitive impairments, pacemakers, or a history of lung diseases like asthma or COPD.

Inclusion Criteria

MAS score ≥ 1, i.e., detectable finger flexor hypertonia

I have had one stroke, regardless of its type or size.

I had a stroke more than 6 months ago and am now medically stable.

Exclusion Criteria

I have a history of lung disease such as asthma or COPD.

Patients with a pacemaker

Patients with visual deficit/neglect, hearing or cognitive impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Breathing-controlled electrical stimulation (BreEStim) or EStim for finger flexor spasticity reduction and hand function improvement

1 session

1 visit (in-person)

Follow-up

Participants are monitored for changes in finger flexor spasticity and hand function using Fugl Myer Assessment and Modified Ashworth Scale

5 minutes after intervention

What Are the Treatments Tested in This Trial?

Interventions

• BreEStim

Trial Overview The study is testing the effectiveness of Breathing-controlled electrical stimulation (BreEStim) compared to regular electrical stimulation (EStim) on reducing finger stiffness and improving hand function in people with moderate impairment after a stroke.

How Is the Trial Designed?

Group I: EStim Experimental Treatment 1 Intervention

EStim is transcutaneous electrical nerve stimulation.

Group II: BreEStim Experimental Treatment 1 Intervention

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study of 123 patients undergoing deep brain stimulation (DBS) surgery, adverse events (AEs) occurred in 14.6% of cases, but all resolved without permanent effects, indicating a relatively safe profile for the procedure.

The study found that rates of complications such as infections and lead revisions were comparable to existing literature, suggesting that the proposed categories for assessing AEs are effective for evaluating DBS safety and can help in benchmarking against other studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature. Engel, K., Huckhagel, T., Gulberti, A., et al.[2019]

This study presents the first case of safely administering electroconvulsive therapy (ECT) to a patient with deep brain stimulation (DBS) by temporarily interrupting DBS only during the ECT sessions.

Previous reports indicated no adverse events when DBS was withheld for the entire ECT course, but this case suggests that short interruptions during ECT may be a safe approach, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary interruption of deep brain stimulation for Parkinson's disease during outpatient electroconvulsive therapy for major depression: a novel treatment strategy. Ducharme, S., Flaherty, AW., Seiner, SJ., et al.[2011]

High-intensity functional electric stimulation (FES)-assisted exercise therapy (FES-ET) significantly improved motor function in stroke survivors, as measured by the Wolf Motor Function Test (WMFT), compared to low-intensity FES-ET, with a notable effect size of 0.95.

Despite the improvements in objective measures of motor function, self-assessments of motor activity (Motor Activity Log) and overall function (Fugl-Meyer Assessment) did not show significant differences, raising questions about the clinical relevance of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. Kowalczewski, J., Gritsenko, V., Ashworth, N., et al.[2016]

In a study involving 14 hemiplegic patients recovering from stroke or head injury, short, intensive multichannel electrical stimulation therapy helped all participants achieve independent ambulation with a crutch after an average of 14 sessions.

The therapy involved stimulating multiple muscle groups using a portable device, which allowed for detailed analysis of gait parameters, indicating its potential effectiveness in improving walking ability in hemiplegic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of gait with multichannel electrical stimulation. Malezic, M., Bogataj, U., Gros, N., et al.[2022]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., 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]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04752319

BreEStim for Motor Recovery in Chronic Stroke With ... The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3582688/

Breathing-controlled Electrical Stimulation (BreEStim) for ... The BreEStim protocol has demonstrated clinical efficacy for neuropathic pain and post-stroke spasticity management. Further research is ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23353138/

Breathing-controlled Electrical Stimulation (BreEStim) for ... BreEStim integrates intrinsic physiological interactions that are activated during voluntary breathing and has demonstrated excellent clinical ...

4. semanticscholar.org semanticscholar.org/paper/Breathing-controlled-Electrical-Stimulation-for-of-Li/03033b3d2b4c434cd1851e551e8e3a16edca28dc

Breathing-controlled Electrical Stimulation (BreEStim) for ... Breathing-controlled electrical stimulation could modify the affective component of neuropathic pain after amputation: a case report · Medicine. Journal of pain ...

5. mdpi.com mdpi.com/2227-9032/10/4/704

Efficacy of Four-Channel Functional Electrical Stimulation ... EMG-MES treatment demonstrated a higher gain of CVM and self-reported daily activities, arm-hand use, and stroke recovery compared to cNMES treatment of the ...

6. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... No serious adverse events related to ARCEX Therapy were reported, and the primary effectiveness endpoint was met. Seventy-two percent of ...

7. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/medicaid-comm-plan/ne/electrical-stimulation-treatment-pain-muscle-rehabilitation-ne-cs.pdf

electrical-stimulation-treatment-pain-muscle-rehabilitation- ... The four primary outcomes were voluntary strength [muscle torque in Newton meters. (Nm)], endurance (fatigue ratio), and performance and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1877065715000780

Sites of electrical stimulation used in neurology Prolonged SES alone improved motor skills in patients with SCI [59] or stroke [60] and corticospinal excitability. In addition, the functional effects of motor ...