HIFEM and Radiofrequency for Muscle Weakness

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called BTL-899M to determine its effectiveness in improving leg muscle strength. Researchers aim to compare this device to a placebo by measuring participants' leg strength three months post-treatment. Individuals with leg muscle weakness who can maintain their regular exercise and diet routines may be suitable for this trial. Participants must attend six visits in total, including both treatment and follow-up sessions. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatments.

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.

What prior data suggests that the BTL-899M device is safe for improving muscular system function?

A previous study tested the BTL-899M device for safety and effectiveness in toning muscles, such as those in the buttocks. The research found that most participants did not experience serious side effects, indicating the device was generally well-tolerated. Another study on similar devices demonstrated that treatments using high-intensity focused electromagnetic (HIFEM) technology, like the BTL-899M, were safe for strengthening muscles and reducing fat. These findings suggest that the BTL-899M device is likely safe for improving muscle function, based on the available evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BTL-899M treatment for muscle weakness because it leverages a novel combination of High-Intensity Focused Electromagnetic (HIFEM) technology and radiofrequency, which is distinct from traditional exercises and physical therapy. Unlike standard treatments that primarily rely on physical rehabilitation to strengthen muscles, BTL-899M applies electromagnetic energy to stimulate muscle contractions, potentially enhancing muscle strength and function more effectively and efficiently. This non-invasive approach offers a promising alternative by directly engaging muscle tissues without the need for vigorous physical activity, making it an attractive option for individuals who may struggle with conventional exercise routines.

What evidence suggests that the BTL-899M device is effective for improving muscle function?

Research has shown that high-intensity focused electromagnetic (HIFEM) therapy can improve muscle tone and strength. In this trial, participants will receive treatments with the BTL-899M device. Studies have demonstrated that devices like the BTL-899M enhance body shape by strengthening muscles. Specifically, research has found that these electromagnetic treatments can lead to better muscle definition and function. Early findings suggest that this therapy is safe and effective for improving muscle tone, particularly in the lower body. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12407011/

Evaluating the Efficacy of High-Intensity Focused ... This study aimed to evaluate the efficacy and safety of high-intensity focused electromagnetic (HIFEM) therapy as a non-invasive treatment for ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04871503

Study Details | NCT04871503 | High-Intensity Focused ... This study will evaluate the clinical efficacy and safety of the BTL-899 device for toning of buttocks. The study is a prospective multi-center open-label two- ...

3. journals.lww.com journals.lww.com/annalsplasticsurgery/fulltext/2025/02000/body_contouring_with_electromagnetic_treatment.19.aspx

Body Contouring With Electromagnetic Treatment Plus... Cohen et al10 suggest that weak lateral abdominal muscles can lead to poor ... muscle contouring than high-intensity focused electromagnetic field procedure alone ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37957393/

High-Intensity Focused Electromagnetic (HIFEM) Energy ... In this study, we conduct a high-quality systematic review to evaluate outcomes for Emsculpt and Emsculpt NEO treatments for noninvasive body ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/jocd.14203

The role and clinical benefits of high‐intensity focused ... Too Short Weak Medium Strong Very Strong Too Long. Your password must have 10 characters or more: a lower case character,; an upper case ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6585690/

High intensity focused electromagnetic therapy evaluated ... The 6 month data suggest that the muscles ... Excitability changes induced in the human motor cortex by weak transcranial direct current ...

7. ctv.veeva.com ctv.veeva.com/study/hifem-and-radiofrequency-for-muscular-system-function-improvement

HIFEM and Radiofrequency for Muscular System Function ... Muscle Weakness. Treatments. Device: Treatment with BTL-899M with ... This study will evaluate the clinical efficacy and safety of the BTL-899M ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7869812/

A German Prospective Study of the Safety and Efficacy ... This study evaluated the efficacy of a novel treatment method utilizing high-intensity focused electromagnetic field (HIFEM) in reducing fat and strengthening ...