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Behavioural Intervention

Electrical Muscle Stimulation Exercise for Myasthenia Gravis

N/A

Recruiting

Led By Kristina M Kelly, DPT

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On stable MG therapy for at least 1 year

Diagnosed with Generalized Myasthenia Gravis (gMG) via seropositive test for acetylcholine receptor (AChR) antibodies or seronegative test with clinical symptoms consistent with gMG

Must not have

Record of seropositive test for MuSK or LRP4 antibodies

Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease, cardia arrhythmia, neoplasm, uncontrolled hypertension)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured within 3 days of starting the intervention and within 3 days of completing the intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine if exercising with electrical muscle stimulation can help adults with Myasthenia Gravis, a muscle weakness disorder, reduce fatigue and improve transmission between muscles and nerves.

Who is the study for?

Adults with Generalized Myasthenia Gravis who've been on stable MG therapy for at least a year, can stand for about 15 minutes, and have mild to moderate muscle weakness. They should not be in other studies, have certain medical conditions or implants that affect safety during the exercise, or be doing regular strength training.

What is being tested?

The trial is testing if Whole-body Electrical Muscle Stimulation Exercise (WB-EMS) can improve muscle communication and reduce fatigue in adults with Myasthenia Gravis. Participants will do WB-EMS twice weekly for four weeks while their neuromuscular function is monitored.

What are the potential side effects?

Potential side effects of WB-EMS may include skin irritation where electrodes are placed, muscle soreness after exercise sessions, and possible discomfort from the electrical stimulation during the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a consistent treatment for myasthenia gravis for at least 1 year.

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I have been diagnosed with Generalized Myasthenia Gravis.

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I experience mild to moderate weakness when holding my arm or leg out.

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I am 18 years old or older.

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I can stand for 15 minutes with or without help.

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I can move my major muscles against gravity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tested positive for MuSK or LRP4 antibodies.

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I do not have any unstable illnesses like kidney failure or uncontrolled high blood pressure.

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I have a condition affecting my muscle control or sensation.

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I can fully extend my arms and legs without any weakness.

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I haven't had any major joint or spine surgeries in the last year.

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I cannot stand for 15 minutes straight, even with support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured within 3 days of starting the intervention and within 3 days of completing the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured within 3 days of starting the intervention and within 3 days of completing the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured within 3 days of starting the intervention and within 3 days of completing the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change from baseline in single fiber electromyography (SFEMG) jitter

Mean change from baseline in the linear change in performance during the arm movement test (AMT)

Mean change from baseline in the linear change in performance during the six-minute walk test (6MWT)

Secondary study objectives

Mean change from baseline in fatigue severity scale (FSS)

Mean change from baseline in motor unit firing rates of the middle deltoid using decomposition electromyography (dEMG)

Mean change from baseline in motor unit firing rates of the vastus lateralis using decomposition electromyography (dEMG)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Whole-body Electrical Muscle Stimulation (WB-EMS) ExerciseExperimental Treatment1 Intervention

All participants will receive the WB-EMS Exercise intervention 2 times per week for 4 weeks. Participants will only perform Level 1 exercise programs (simple movements) in the "Strength" Training Mode. These programs are 20-minute videos led by exercise professionals. They are full-body workouts with no one muscle group receiving more attention than another. They consist of 10-12 exercises performed for 14 repetitions. Each repetition takes 4 seconds to complete (the time that the stimulation is "on") and is followed by a 4 second rest (the time that the stimulation is "off"). All exercises occur in a double-limb stance position. Most exercises occur with feet in wide base of support, hips width or more apart. All exercises are modifiable by the healthcare professional administering and monitoring the intervention based on participant's safe and available range of motion (i.e. arm movements, torso positions, extent of knee bend).

0 / 12Eligibility criteria met