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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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).
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterOTHER
463 Previous Clinical Trials
169,254 Total Patients Enrolled
2 Trials studying Myasthenia Gravis
62 Patients Enrolled for Myasthenia Gravis
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,098 Total Patients Enrolled
Kristina M Kelly, DPTPrincipal InvestigatorUniversity of Missouri-Columbia
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this study open at present?
"Clinical trials.gov reveals that this trial is no longer enrolling participants, with the initial posting on July 12th 2023 and the last edit being made on September 26th 2023. However, there are currently 85 other medical studies actively seeking patients to join their research efforts."
Answered by AI
What is the purpose of this investigation?
"The primary evaluation objective of this trial is to measure the linear change in performance during a 6-minute walking test within 3 days pre and post treatment. Other secondary outcomes that will be monitored include dEMG readings from both the vastus lateralis and middle deltoid muscles, as well as changes in fatigue severity scale over a 7 day period."
Answered by AI
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