Recruiting

BreEStim

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04752319

Conditions

Motor Recovery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BreEStim

EStim

Study Details

Brief 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 moderate impairment after a long-term use.

Conditions

Motor Recovery

Study ID

NCT04752319

Start date

Sep 1, 2025

Status verified date

May, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

4 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BreEStim

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

experimental: EStim

EStim is transcutaneous electrical nerve stimulation.

Interventions

BreEStim

BreEStim will be applied for 10 to 20 minutes per session for multiple sessions

EStim

EStim will be applied for 10 to 20 minutes per session for multiple sessions

Primary outcome measure

  • Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS) [ Time Frame: Baseline, after 10 intervention sessions, about 3 weeks ]

Central Contacts and Locations

Central contacts

Sheng Li, MD, PhD

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

Shengai Li, MS

713-797-7561shengai.li@uth.tmc.edu

Locations

The University of Texas Health Science Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Sheng Li, MD, PhD

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

Shengai Li, MS

713-797-7561shengai.li@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 3, 2026

Last verified

May, 2026

Keywords

  • Finger flexor spasticity
  • Motor Recovery
  • BreEStim

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-06-03.