BreEStim for Motor Recovery After Stroke

SL
Shengai Li, MD, PhD profile photo
Overseen ByShengai Li, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment called BreEStim, which uses breathing to control electrical stimulation, can reduce finger stiffness and improve hand function in stroke survivors. It compares BreEStim to another technique, EStim, which also uses electrical stimulation. Suitable candidates for this trial have experienced a stable stroke for at least six months, have noticeable finger stiffness, and have no vision or hearing issues.

As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance recovery and quality of life after a stroke.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently adjusting medications that affect muscle tone, like baclofen.

What prior data suggests that BreEStim is safe for motor recovery after stroke?

Research shows that BreEStim, a type of electrical stimulation controlled by breathing, is under study for its effects on stroke recovery. This method uses gentle electrical currents to target specific muscles, and similar techniques have been used in various muscle therapies. Although specific safety data on BreEStim is limited, electrical stimulation therapies are generally well-tolerated by many people.

If BreEStim were in a later trial phase, more information about its safety would be available. However, since it is in an early stage, a complete safety profile is not yet established. Still, the widespread use of electrical stimulation in other treatments suggests it is likely safe for many people. Participants should discuss any concerns with their doctors.12345

Why are researchers excited about this trial?

Researchers are excited about BreEStim because it introduces a novel approach to stroke recovery by combining voluntary breathing with transcutaneous electrical nerve stimulation (EStim). This method leverages the natural rhythm of breathing to potentially enhance nerve stimulation, which could improve motor recovery more effectively than traditional methods like physical therapy alone. Unlike conventional treatments, BreEStim offers a non-invasive and potentially faster way to restore motor function, providing hope for better outcomes in stroke rehabilitation.

What evidence suggests that BreEStim is effective for motor recovery after stroke?

Research has shown that BreEStim, which combines breathing exercises with gentle electrical nerve stimulation, might improve hand movement and reduce finger stiffness after a stroke. In this trial, participants will receive either BreEStim or EStim, which involves transcutaneous electrical nerve stimulation. Studies have found that electrical stimulation can significantly enhance movement control in stroke patients. Those who have used these methods alongside regular therapy have experienced noticeable improvements in recovery. This suggests that BreEStim could benefit individuals with moderate difficulties from a long-term stroke. While researchers continue to collect data, early results offer hope for those aiming to regain hand function after a stroke.12678

Who Is on the Research Team?

SL

Sheng Li, MD, PhD

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

MAS score ≥ 1, i.e., detectable finger flexor hypertonia
I had a stroke more than 6 months ago and am now medically stable.
I had a stroke more than 6 months ago and am now medically stable.
See 1 more

Exclusion Criteria

Patients with a pacemaker
I am not currently changing doses of medications like baclofen.
I have hearing or cognitive difficulties.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BreEStim or EStim intervention for finger flexor spasticity reduction and hand function improvement

3 weeks
10 intervention sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BreEStim
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: EStimExperimental Treatment1 Intervention
Group II: BreEStimExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Citations

BreEStim for Motor Recovery in Chronic Stroke With ...The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor ...
Study Details | BreEStim for Motor Recovery in Chronic Stroke ...An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...
BreEStim for Motor Recovery in Chronic Stroke With Moderate ...The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger ...
The effectiveness of theta burst stimulation for motor recovery ...Our results show that TBS has a good effect on improving motor function in stroke patients, but more large-scale, high-quality, multicenter ...
Functional electrical stimulation enhances motor control in ...Results: The study found that integrating electrical stimulation with early rehabilitation markedly enhanced stroke patients' recovery. After 8 weeks, ...
BreEStim for Stroke · Info for ParticipantsThis 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.
Breathing-controlled Electrical Stimulation (BreEStim) for ...A new EStim protocol, Breathing-controlled Electrical Stimulation (BreEStim), has been developed to augment the effects of electrical stimulation.
Breathing-controlled Electrical Stimulation (BreEStim) for ...Electrical stimulation therapy, which uses small electrodes to send electrical currents through the skin to target certain muscle groups, has a broad range.
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