HIFEM and Radiofrequency for Muscle Weakness

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BTL Industries Ltd.

Must not be taking: Anticoagulants

Disqualifiers: Cardiovascular diseases, Metal implants, others

Compensation: Varies

Number of Visits: 6

Duration: 4-6 weeks

33 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to investigate the effect of the BTL-899M device on muscular system function in adult subjects seeking treatment for improving their muscular system function in the lower extremities. The main question it aims to answer is: Whether the BTL-899M device is effective for muscular system function improvement 3 months posttreatment compared to the sham group, based on the dynamometer measurement. Researchers will compare a sham group to see if the device is effective. Participants will complete four treatment visits and two follow-up visits. Their strength will be recorded via a dynamometer.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be willing to abstain from any new treatments for improving the musculoskeletal system during the study.

How is the treatment BTL-899M for muscle weakness different from other treatments?

BTL-899M combines high-intensity focused electromagnetic (HIFEM) technology with radiofrequency to strengthen muscles, which is unique compared to traditional treatments that may not use these technologies together. This combination can potentially enhance muscle strength and reduce muscle fatigue more effectively than standard therapies. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults seeking to improve muscle function in their lower extremities, possibly due to conditions like pediatric hemiparesis or general muscular weakness. Participants must be able to attend four treatment and two follow-up visits.

Inclusion Criteria

Voluntarily signed an informed consent form

BMI ≤ 35 kg/m2

Women of child-bearing potential are required to use birth control measures during the whole duration of the study

Exclusion Criteria

Drug pumps

I have a contagious skin condition.

I have trouble breathing or lung problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four BTL-899M treatments applied to the lower extremities, with each session lasting 30 minutes and delivered 5-10 days apart

4-6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with strength measurements and questionnaires administered

3 months

2 visits (in-person)

Treatment Details

Interventions

• BTL-899M

Trial Overview The study tests the BTL-899M device's effectiveness on muscle function. One group receives actual treatment while a sham (placebo) group gets non-therapeutic intensity treatments. Muscle strength is measured with a dynamometer three months post-treatment.

Participant Groups

Group I: Treatment with BTL-899M Experimental Treatment 1 Intervention

Four (4) BTL-899M treatments will be applied to the lower extremities.

Group II: Treatment with BTL-899M with intensities below therapeutic threshold Placebo Group 1 Intervention

Four (4) BTL-899M treatments will be applied to the lower extremities, with intensities below therapeutic threshold

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials

59

Recruited

2,000+

Findings from Research

Electrical impedance myography (EIM) is a noninvasive technique that quantitatively assesses muscle condition, aiding in the diagnosis and monitoring of diseases like amyotrophic lateral sclerosis and muscular dystrophy.

EIM has shown sensitivity to disease status and may allow for clinical trials to be conducted with fewer participants, making it a promising tool for evaluating muscle health and therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Impedance Methods in Neuromuscular Assessment: An Overview. Rutkove, SB., Sanchez, B.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Test-retest reliability of wide-pulse high-frequency neuromuscular electrical stimulation evoked force. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Changes in EMG power spectrum (high-to-low ratio) with force fatigue in humans. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Electrical impedance myography in the diagnosis of radiculopathy. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Electrical Impedance Methods in Neuromuscular Assessment: An Overview. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Computational Study on Spatially Distributed Sequential Stimulation for Fatigue Resistant Neuromuscular Electrical Stimulation. [2022]