Motor RecoveryNCT04750551
BreEStim for Post-Stroke Motor Recovery
A study testing BreEStim and EStim in people with Motor Recovery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Motor Recovery
- What is being tested?
- BreEStim and EStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center
Houston, Texas, 77030
Sheng Li, MD, PhD, (713) 500-5874, sheng.li@uth.tmc.edu
Shengai Li, MS, 713-797-7561, shengai.li@uth.tmc.edu
About this study
Official title: BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).
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.
- Conditions
- Motor Recovery
- Being tested
- BreEStim, EStim
- Keywords
- Finger flexor spasticity, Motor Recovery, BreEStim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreEStimDevice
BreEStim will applied for 10 to 20 minutes.
EStimDevice
EStim will applied for 10 to 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| BreEStim | Experimental | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. Receives: Device: BreEStim |
| EStim | Experimental | EStim is transcutaneous electrical nerve stimulation. Receives: Device: EStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)
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
Measured: Baseline, 5 minutes after intervention
Secondary outcomes (1)
Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale
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.
Measured: Baseline, 5 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Nov 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor RecoveryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Li, The University of Texas Health Science Center, Houston
- Investigators
- Sheng Li, MD, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750551
- Sponsor's protocol ID
- HSC-MS-20-1286 (Experiment 1)
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).
- ClinicalTrials.gov ID
- NCT04750551
- Acronym / sponsor ID
- HSC-MS-20-1286 (Experiment 1)
- Conditions
- Motor Recovery
- Keywords
- Finger flexor spasticity, Motor Recovery, BreEStim
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BreEStim | Experimental | Device: BreEStimBreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. |
| EStim | Experimental | Device: EStimEStim is transcutaneous electrical nerve stimulation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreEStimBreEStim will applied for 10 to 20 minutes. | Device | BreEStim |
| EStimEStim will applied for 10 to 20 minutes. | Device | EStim |
Primary outcome
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 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
1 secondary outcome
Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale
Time frame: Baseline, 5 minutes after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheng Li, MD, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BreEStim and EStim in people with Motor Recovery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Li, MD, PhD ((713) 797-7125, sheng.li@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS) (time frame: Baseline, 5 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.