BreEStim 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 severe 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.

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 experience detectable muscle tightness in their fingers. It's not suitable for those adjusting to muscle relaxant medications, with pacemakers, recent toxin injections in the arm/fingers, pregnant women, or those with visual/hearing/cognitive impairments or pulmonary diseases.

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 have had one stroke.

Exclusion Criteria

Women who are pregnant

Patients with a pacemaker

I haven't changed my muscle relaxant medications or had certain injections in my arm/fingers recently.

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 MAS and FMA scales

5 minutes after intervention

Treatment Details

Interventions

• BreEStim

Trial Overview The study tests Breathing-controlled electrical stimulation (BreEStim) to see if it helps reduce hand spasticity and improve hand function in people with severe impairment after a stroke. Participants will receive this novel intervention and its effects on motor recovery will be evaluated.

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+