BreEStim for Motor Recovery After Stroke

Recruiting at -1 trial locations

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: 10

Duration: 3 weeks

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 after a long-term use.

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.

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

BreEStim is unique because it combines electrical stimulation with exercise to enhance motor recovery after a stroke, potentially offering a novel approach compared to traditional therapies like repetitive exercise or virtual reality, which focus on task-specific training and brain remodeling. ^{1 2 3 4 5}

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, resulting in moderate hand impairment due to muscle stiffness. They must be medically stable and not have visual, hearing or cognitive impairments, severe lung diseases, recent botulinum toxin or phenol injections in the arm/fingers, pacemakers, or be pregnant.

Inclusion Criteria

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

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

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

Exclusion Criteria

Patients with a pacemaker

I am not currently changing doses of medications like baclofen.

I have hearing or cognitive difficulties.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BreEStim or EStim intervention for finger flexor spasticity reduction and hand function improvement

3 weeks

10 intervention sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BreEStim

Trial Overview The study tests Breathing-controlled electrical stimulation (BreEStim) to see if it helps reduce hand muscle stiffness and improve function in people with chronic stroke. Participants will receive this novel therapy over a period to assess its long-term effectiveness.

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Predicting and accelerating motor recovery after stroke. [2022]

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

Generalizability of the Proportional Recovery Model for the Upper Extremity After an Ischemic Stroke. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Combined rTMS and virtual reality brain-computer interface training for motor recovery after stroke. [2019]

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

Stroke rehabilitation: strategies to enhance motor recovery. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of the immediate effect of the training with a virtual reality game in stroke patients according side brain injury. [2018]