Electrical Stimulation for Sarcopenia

(microG Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

Must not be taking: Anti-inflammatories, Corticosteroids

Disqualifiers: Diabetes, Hypertension, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the changes of muscle, in microgravity. Which will help explain the health benefits of exercise. There are tests that can be done to tell researchers more about the human body, such as a dual energy x-ray absorptiometry (DEXA) scan, which measures body composition (fat and lean body mass). The use of muscle testing and a Handgrip test can tell us about the strength and power within an individual's muscles. A VO2 max test helps us understand the aerobic fitness level of an individual and one of the most important aspects of this study are muscle cells. A muscle biopsy allows us to obtain muscle cells from the thigh, which will be sent into space by a rocket. Researchers will study these muscle cells in a low gravity environment aboard the International Space Station. Studying the muscle cells under those conditions will potentially mimic an accelerated aging process, which will help researchers better understand muscle wasting in the elderly.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking prescription strength anti-inflammatory medication, you must not have taken it in the 6 weeks prior to screening.

What data supports the effectiveness of the treatment Electrical Stimulation for Sarcopenia?

Research shows that neuromuscular electrical stimulation (NMES) can help improve muscle strength, balance, and daily activities in older adults, which may help manage sarcopenia. NMES has been found to reduce muscle loss and improve muscle function, making it a promising treatment for this condition. ^{1 2 3 4 5}

Is electrical stimulation safe for treating sarcopenia?

Research suggests that electrical stimulation is a safe method to counteract muscle decline associated with aging, as it improves muscle function and structure without significant side effects. ^{2 6 7 8 9}

How does electrical stimulation treatment for sarcopenia differ from other treatments?

Electrical stimulation for sarcopenia is unique because it uses electrical impulses to stimulate muscle contractions, which can help improve muscle strength and mass without the need for physical exercise. This is different from traditional treatments like exercise and nutrition, which require active participation and lifestyle changes. ^{1 5 8 10 11}

Research Team

Paul Coen, PhD

Principal Investigator

Study Principal Investigator

Eligibility Criteria

This trial is for healthy adults aged 20-40 or 60-80 with a BMI under 30, able to consent and follow the study protocol. Excluded are those actively changing their lifestyle for weight loss, with severe uncontrolled symptoms like diarrhea, high/low blood pressure, recent surgery or hospitalization, infectious diseases (e.g., HIV), pregnant/lactating women postpartum within 6 weeks, tobacco users in the last three months, diabetics or those with clotting disorders.

Inclusion Criteria

I am willing to follow the study's rules and complete all required forms.

You weigh less than 30 kilograms for every square meter of your height.

I have signed the consent form and agreed to share my health information for this study.

Exclusion Criteria

I have a history of blood clots or a condition that increases my risk for clots.

My liver function is significantly impaired, or my liver tests are more than 2.5 times the normal limit.

You have had an amputation or use a partial or full artificial limb.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Muscle Biopsy and Testing

Muscle biopsy specimens are obtained from participants and various tests such as DEXA scan, muscle testing, Handgrip test, and VO2 max test are conducted.

1-2 weeks

Microgravity Experimentation

Muscle cells obtained from biopsies are sent to the International Space Station for study in a microgravity environment.

Duration not specified

Follow-up

Participants are monitored for any post-biopsy effects and overall health status.

4 weeks

Treatment Details

Interventions

• Maximal Oxygen Consumption (V02max)
• Muscle Tissue Biopsy

Trial Overview The study tests how muscle cells from thigh biopsies behave in microgravity aboard the International Space Station. It aims to simulate accelerated aging and understand muscle wasting. Participants undergo body composition scans (DEXA), strength tests (Handgrip test), aerobic fitness assessments (VO2 max test), and provide muscle tissue samples.

Participant Groups

Group I: Young adults Experimental Treatment 2 Interventions

Obtain muscle biopsy specimens from young adults (ages 20-40) to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures.

Group II: Older adults Experimental Treatment 2 Interventions

Obtain muscle biopsy specimens from older adults (ages 60-80) to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures.

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials

41

Recruited

3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

References

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

Tools in the assessment of sarcopenia. [2022]

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

Functional Electrical Stimulation Leads to Increased Volume of the Aged Thyroarytenoid Muscle. [2020]

3. Japan pubmed.ncbi.nlm.nih.gov

Effects of neuromuscular electrical stimulation of quadriceps on the quadriceps strength and functional performance in nursing home residents: A comparison of short and long stimulation periods. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Muscle plasticity of aged subjects in response to electrical stimulation training and inversion and/or limitation of the sarcopenic process. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Exercise interventions in healthy older adults with sarcopenia: A systematic review and meta-analysis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Electrical stimulation counteracts muscle decline in seniors. [2022]

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

The effects of whole-body muscle stimulation on body composition and strength parameters: A PRISMA systematic review and meta-analysis. [2023]

8. Japan pubmed.ncbi.nlm.nih.gov

[Treatment indications for sarcopenia: a systematic review of exercise intervention effect]. [2019]

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

Silver electroceutical technology to treat sarcopenia. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Prevalence of and interventions for sarcopenia in ageing adults: a systematic review. Report of the International Sarcopenia Initiative (EWGSOP and IWGS). [2022]

11. Greece pubmed.ncbi.nlm.nih.gov

Comparison of Habitual and Maximal Gait Speed and their Impact on Sarcopenia Quantification in German Nursing Home Residents. [2022]