RecruitingNot Applicable

BreEStim for Motor Recovery in Chronic Stroke With Severe Impairment (Pilot)

United States4 participantsStarted 2025-09-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * has post stroke ≥ 6 months , medically stable; * Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke); * MAS score ≥ 1, i.e., detectable finger flexor hypertonia; Exclusion criteria include: * Patients with visual deficit/neglect; hearing or cognitive impairment; * Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD); * Patients that are currently adjusting tone alternating medications (e.g., baclofen), or * Patients received botulinum toxin injection to the arm/fingers \<4 months, or phenol injections \< 2 years; * Patients with a pacemaker; * Women who are pregnant.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)

Timeframe: Baseline, 5 minutes after intervention

Trial details

NCT IDNCT04750564

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Sheng Li, MD, PhD

(713) 797-7125 sheng.li@uth.tmc.edu

View on ClinicalTrials.gov More Motor Recovery trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.