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

4 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment.

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 data supports the effectiveness of the treatment BreEStim for stroke?

Research shows that electrical stimulation treatments, like BreEStim, can help improve movement and function in stroke patients by retraining muscles and enhancing brain activity. Similar treatments have been shown to help patients regain movement and reduce muscle stiffness. ^{1 2 3 4 5}

Is electrical stimulation generally safe for humans?

Transcranial electrical stimulation (tES) has been found to be generally safe with limited outputs, showing non-significant risk in clinical populations. However, the long-term safety in healthy individuals has not been fully tested. ^{6 7 8 9 10}

How does the BreEStim treatment for stroke differ from other treatments?

BreEStim is unique because it combines electrical stimulation with a focus on brain engagement to improve motor function after a stroke, unlike traditional therapies that may only use electrical stimulation on muscles. ^{2 3 5 11 12}

Research Team

Sheng Li, MD, PhD

Principal Investigator

University of Texas

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. [2016]

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

Evaluation of gait with multichannel electrical stimulation. [2022]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Electrostimulation for promoting recovery of movement or functional ability after stroke. [2022]

5. Austria pubmed.ncbi.nlm.nih.gov

Neuromodulation by functional electrical stimulation (FES) of limb paralysis after stroke. [2019]

6. United States 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. [2019]

7. United States 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. [2011]

8. United States 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Functional electrical stimulation on improving foot drop gait in poststroke rehabilitation: a review of its technology and clinical efficacy. [2022]

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

Effectiveness of Faradic and Russian currents on plantar flexor muscle spasticity, ankle motor recovery, and functional gait in stroke patients. [2018]