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Electrical Stimulation

BreEStim for Motor Recovery After Stroke

N/A
Waitlist Available
Led By Sheng Li, MD, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has post stroke ≥ 6 months, medically stable
has post stroke ≥ 6 months, medically stable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after 10 intervention sessions, about 3 weeks
Awards & highlights

Study Summary

This trial is investigating whether a new intervention, Breathing-controlled electrical stimulation, is effective in reducing spasticity and improving hand function in people with chronic stroke.

Who is the study for?
This trial is for individuals who have had a stroke at least 6 months ago, resulting in moderate hand impairment due to muscle stiffness. They must be medically stable and not have visual, hearing or cognitive impairments, severe lung diseases, recent botulinum toxin or phenol injections in the arm/fingers, pacemakers, or be pregnant.Check my eligibility
What is being tested?
The study tests Breathing-controlled electrical stimulation (BreEStim) to see if it helps reduce hand muscle stiffness and improve function in people with chronic stroke. Participants will receive this novel therapy over a period to assess its long-term effectiveness.See study design
What are the potential side effects?
Potential side effects of BreEStim may include discomfort at the stimulation site, skin irritation from electrode placement, fatigue during treatment sessions and possible transient increase in muscle tone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a stroke more than 6 months ago and am now medically stable.
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I had a stroke more than 6 months ago and am now medically stable.
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I have had one stroke, regardless of its type or size.
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I have had one stroke, regardless of its type or size.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after 10 intervention sessions, about 3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 10 intervention sessions, about 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)
Secondary outcome measures
Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale

Trial Design

2Treatment groups
Experimental Treatment
Group I: EStimExperimental Treatment1 Intervention
EStim is transcutaneous electrical nerve stimulation.
Group II: BreEStimExperimental Treatment1 Intervention
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BreEStim
2015
N/A
~20

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
321,117 Total Patients Enrolled
3 Trials studying Motor Recovery
22 Patients Enrolled for Motor Recovery
Sheng Li, MD, PhD4.896 ReviewsPrincipal Investigator - University of Texas
Swedish Medical Center / First Hill Campus, Swedish Medical Center / Cherry Hill Campus, Swedish Medical Center / Issaquah Campus
Medical School - Rosalind Franklin University of Medicine and Science, Doctor of Medicine
Louisiana State University, Residency in Ophthalmology
8 Previous Clinical Trials
97 Total Patients Enrolled
2 Trials studying Motor Recovery
8 Patients Enrolled for Motor Recovery
5Patient Review
Dr. Chen was affable and willing to answer any questions I had. The staff was hospitable and friendly as well. I would recommend them highly.

Media Library

BreEStim (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04752319 — N/A
Motor Recovery Research Study Groups: EStim, BreEStim
Motor Recovery Clinical Trial 2023: BreEStim Highlights & Side Effects. Trial Name: NCT04752319 — N/A
BreEStim (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752319 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elders aged 65 and above eligible to participate in the experiment?

"This clinical trial is open to patients aged between 18 and 75, adhering to the designated eligibility criteria."

Answered by AI

Are there still openings available for participants in this experiment?

"Based on the information available through clinicaltrials.gov, this research project is no longer enrolling patients. First posted August 2nd 2022 and last updated April 23rd 2022, it has since been replaced by 5 other studies that are presently seeking volunteers."

Answered by AI

Who is eligible to participate in this research?

"For this research, 4 individuals aged between 18 and 75 who have experienced some motor recovery are being accepted. As well as fitting into the specified age range they must also meet other criteria such as: having had a stroke of any type or size for over 6 months; displaying medically stable behaviour; attaining at least a score of 1 on Modified Ashworth Scale (MAS)."

Answered by AI

Who else is applying?

What site did they apply to?
The University of Texas Health Science Center
What portion of applicants met pre-screening criteria?
Met criteria
~3 spots leftby Aug 2027