BreEStim for Motor Recovery in Chronic Stroke

This pilot study is exploring a new treatment called BreEStim (Breathing-controlled electrical stimulation) to help people who have had a stroke. It aims to see if BreEStim can reduce stiffness (spasticity) in finger muscles and improve hand function. The study is also comparing BreEStim to standard electrical stimulation (EStim). You might be able to join if you are 18 to 75 years old, had a stroke at least 6 months ago, and have some finger stiffness. People with certain vision, hearing, or thinking problems, or lung disease, cannot participate. The study is currently unclear about its recruitment status and plans to enroll 4 participants.

Study design
This is an interventional pilot study with a planned enrollment of 4 participants. It is comparing two device interventions: BreEStim and EStim.
What's involved
You would receive either BreEStim or EStim for 10 to 20 minutes. Your finger stiffness will be measured at the start and 5 minutes after the intervention.
Compensation
Not stated in the trial record.
Follow-up
Your finger stiffness will be measured 5 minutes after the intervention.

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NCT04750564

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

Recruiting
NAAges 18–75InterventionalTreatment
The University of Texas Health Science Center, Houston
~4 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:BreEStimEStim

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)
Measured over Baseline, 5 minutes after intervention
Motor Recovery
1 sites across 1 states
Texas1
  • Sheng Li, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Texas

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Eligibility criteria

Inclusion

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

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.
  • Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)Baseline, 5 minutes after intervention

    MAS will be performed to check changes of finger flexor spasticity after one session of treatment. The Modified Ashworth scale (MAS) scoring is categorical and ranges from 0 to 4, as follows: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM) 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension