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NCT Number: NCT04750551

BreEStim for Post-Stroke Motor Recovery

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.

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Key information

Conditions

Motor Recovery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BreEStim

Device

BreEStim will applied for 10 to 20 minutes.

EStim

Device

EStim will applied for 10 to 20 minutes.

Primary outcomes

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

    Time frame: 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

    • 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)
    • More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
    • Considerable increase in muscle tone, passive movement difficult
    • Affected part(s) rigid in flexion or extension

Secondary outcomes

  1. Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale

    Time frame: Baseline, 5 minutes after intervention

    FMA will be assessed to test function changes of finger extensors and hand function after one session of treatment.

    The upper limb motor function domain of the FMA scale will be used, and the score range for this domain is 0 to 66, with a higher score indicating better function.

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng Li, MD, PhD

CONTACT

[email protected]

(713) 797-7125

Shengai Li, MS

CONTACT

[email protected]

713-797-7561

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2021
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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