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Electrical Stimulation

BreEStim for 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
Unilateral, single stroke (no restriction on type or volume of stroke)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 minutes after intervention
Awards & highlights

Study Summary

This trial will investigate whether a new intervention, Breathing-controlled electrical stimulation (BreEStim), can reduce spasticity in the fingers and improve hand function in people who have had a stroke.

Who is the study for?
This trial is for individuals who have had a stroke at least 6 months ago, are medically stable, and experience detectable muscle tightness in their fingers. It's not suitable for those adjusting to muscle relaxant medications, with pacemakers, recent toxin injections in the arm/fingers, pregnant women, or those with visual/hearing/cognitive impairments or pulmonary diseases.Check my eligibility
What is being tested?
The study tests Breathing-controlled electrical stimulation (BreEStim) to see if it helps reduce hand spasticity and improve hand function in people with severe impairment after a stroke. Participants will receive this novel intervention and its effects on motor recovery will be evaluated.See study design
What are the potential side effects?
Potential side effects of BreEStim may include discomfort at the site of stimulation, skin irritation from electrode placement, fatigue due to therapy sessions or unexpected reactions like increased spasticity; however specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a stroke more than 6 months ago and am now medically stable.
Select...
I have had one stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 5 minutes after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 5 minutes after intervention 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

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
914 Previous Clinical Trials
324,368 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
4Patient Review
The doctor and his team were thorough in their examination of my eyes. I left feeling satisfied.

Media Library

BreEStim (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04750564 — N/A
Motor Recovery Research Study Groups: EStim, BreEStim
Motor Recovery Clinical Trial 2023: BreEStim Highlights & Side Effects. Trial Name: NCT04750564 — N/A
BreEStim (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04750564 — N/A
~3 spots leftby Dec 2024
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