4 Participants Needed

BreEStim for Stroke

SL
Shengai Li, MD, PhD profile photo
Overseen ByShengai Li, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

SL

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 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.
See 2 more

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 MAS and FMA scales

5 minutes after intervention

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: EStimExperimental Treatment1 Intervention
Group II: BreEStimExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+
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