BreEStim for Stroke

Overseen By Shengai Li, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Tone alternating medications

Disqualifiers: Visual deficit, Pulmonary disease, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a new treatment called BreEStim improves hand function and reduces muscle stiffness in individuals who have experienced a severe stroke. BreEStim involves breathing combined with gentle electrical stimulation on the skin. The study will compare this method to another form of electrical stimulation to determine which is more effective. Individuals who had a stroke over six months ago and have noticeable stiffness in their fingers may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative therapy options for stroke recovery.

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 stroke patients?

Research has shown that BreEStim, a treatment using breathing-controlled electrical stimulation, has been tested in various studies and appears safe. Most reported side effects are minor, indicating that serious problems are uncommon.

Researchers have studied the safety of BreEStim in patients who have had a stroke. The treatment aims to improve movement and reduce muscle stiffness using electrical pulses controlled by breathing. Previous research indicates it is generally safe, with few experiencing major issues.

Overall, BreEStim is usually well-tolerated. Most side effects are minor, such as skin irritation or slight discomfort where the stimulation is applied. This suggests that BreEStim could be a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BreEStim for stroke rehabilitation because it offers a unique approach to nerve stimulation. Unlike traditional treatments that may include physical therapy or medication to improve motor skills, BreEStim combines voluntary breathing with transcutaneous electrical nerve stimulation. This innovative method harnesses the natural rhythm of breathing to enhance the effectiveness of electrical stimulation, potentially offering improved recovery of motor function. Additionally, the EStim component uses a non-invasive technique to stimulate nerves through the skin, which could be more comfortable and accessible for patients compared to other invasive options.

What evidence suggests that BreEStim is effective for reducing finger flexor spasticity and improving hand function in chronic stroke?

Research has shown that Breathing-controlled electrical stimulation (BreEStim), a treatment in this trial, may reduce muscle stiffness and improve hand movement in stroke survivors. Studies have found that this method uses natural breathing patterns to enhance nerve stimulation. Previous cases demonstrated positive results in managing post-stroke symptoms with BreEStim. The treatment effectively relieves pain without requiring fast or deep breathing. These early findings suggest that BreEStim could benefit individuals with long-term stroke-related issues. Another treatment arm in this trial involves EStim, which is transcutaneous electrical nerve stimulation. ^{1 2 6 7 8}

Who Is on the Research Team?

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, 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.

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 have had one stroke.

Exclusion Criteria

Women who are pregnant

Patients with a pacemaker

I haven't changed my muscle relaxant medications or had certain injections in my arm/fingers recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Breathing-controlled electrical stimulation (BreEStim) or EStim for finger flexor spasticity reduction and hand function improvement

1 session

1 visit (in-person)

Follow-up

Participants are monitored for changes in finger flexor spasticity and hand function using MAS and FMA scales

5 minutes after intervention

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 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.

How Is the Trial Designed?

Group I: EStim Experimental Treatment 1 Intervention

EStim is transcutaneous electrical nerve stimulation.

Group II: BreEStim Experimental Treatment 1 Intervention

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04752319

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 ...

2. memorialhermann.org memorialhermann.org/-/media/memorial-hermann/org/files/specialties/tirr/tirr-journal/tirr-journal-spring2013.pdf

Breathing-controlled Electrical Stimulation (BreEStim) for ... In a video article published online, I presented two example cases showing different applications of BreEStim in the clinical setting: management of post-stroke.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23353138/

Breathing-controlled Electrical Stimulation (BreEStim) for ... BreEStim integrates intrinsic physiological interactions that are activated during voluntary breathing and has demonstrated excellent clinical ...

4. semanticscholar.org semanticscholar.org/paper/Breathing-controlled-Electrical-Stimulation-for-of-Li/03033b3d2b4c434cd1851e551e8e3a16edca28dc

Breathing-controlled Electrical Stimulation (BreEStim) for ... The findings suggest that the analgesic effect of BreEStim is not likely attributed to fast and deep voluntary breathing, and the underlying mechanisms ...

5. ctv.veeva.com ctv.veeva.com/study/breestim-for-motor-recovery-in-chronic-stroke-with-moderate-impairment-pilot

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 ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/38/NCT04750538/Prot_SAP_000.pdf

A non-invasive intervention (BreEStim) for management of ... As shown in the pilot data, we expect that BreEStim could have dose-dependent effects on the duration but not the degree of analgesic effects.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3582688/

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.

8. tandf.figshare.com tandf.figshare.com/articles/online_resource/Safety_and_Adverse_Events_following_Non-invasive_Electrical_Brain_Stimulation_in_Stroke_A_Systematic_Review/23519925

Safety and Adverse Events following Non-invasive Electrical ... Conclusion: ES appears safe in people with stroke as reported adverse events were predominantly minor in nature. An adverse events questionnaire ...