What side effects are associated with this type of intervention?

Common treatments for Myasthenia Gravis include cholinesterase inhibitors like pyridostigmine, immunosuppressants, and thymectomy. Side effects of these treatments can include gastrointestinal issues, increased risk of infections, and potential complications from surgery. Acupuncture, a non-pharmacologic treatment being studied for MG, has been associated with minor side effects such as minor bleeding, hematoma, dizziness, xerostomia (dry mouth), loose stool, diarrhea, abdominal pain, skin rash, and fatigue. These side effects are generally mild and transient.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Myasthenia Gravis, including cholinesterase inhibitors like pyridostigmine, immunosuppressants such as azathioprine and mycophenolate mofetil, and monoclonal antibodies like eculizumab. These treatments primarily aim to improve neuromuscular transmission and modulate the immune response. While acupuncture is not FDA-approved for MG, it is being studied for its potential to enhance acetylcholine receptor expression and improve quality of life in MG patients, similar to the effects of cholinesterase inhibitors.

What other types of research exist?

Promising novel alternatives to acupuncture for Myasthenia Gravis patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in modulating neurological functions and may be useful for patients who do not respond to first-line therapies. 2) Noninvasive Vagus Nerve Stimulation (nVNS), which may benefit patients by modulating immune responses and neurological functions. Both therapies have demonstrated potential in clinical trials and are available in the United States and other regions.

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Acupuncture for Myasthenia Gravis

N/A

Waitlist Available

Led By Gaurav K Guliani, MD

Research Sponsored by HealthPartners Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre/post - 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether acupuncture can help people with Myasthenia Gravis (MG). Twenty patients will receive acupuncture regularly over a few months. The study aims to see if acupuncture can improve their quality of life and daily activities. Acupuncture has been studied for its effectiveness in treating Myasthenia Gravis (MG) in various contexts.

Who is the study for?

This trial is for adults aged 18-80 with Myasthenia Gravis. Participants must be able to consent and speak English. Excluded are those with bleeding disorders, heart arrhythmias, stimulator devices, recent other trials participation, pregnancy or planning to become pregnant during the study, substance abuse issues, outside acupuncture treatment while enrolled, or serious neurological conditions.

What is being tested?

The AcuMG trial tests if acupuncture can improve life quality in people with Myasthenia Gravis. It involves 20 participants receiving treatments twice weekly for 12 weeks. They're split into two groups: one starts immediately and the other after a delay of 12 weeks (serving as a control group initially).

What are the potential side effects?

Potential side effects from acupuncture may include minor bleeding or bruising at needle sites, rare instances of fainting or dizziness during treatment sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre/post - 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre/post - 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre/post - 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To determine the effect of acupuncture on quality of life in patients with MG

Secondary study objectives

To determine the effect of acupuncture on activities of daily living in patients with MG

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

Study treatment Arm

Bi-Weekly Acupuncture

Wait List

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate StartExperimental Treatment1 Intervention

Patients will receive acupuncture treatment two times per week for 12 weeks.

Group II: Delayed startActive Control1 Intervention

Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Myasthenia Gravis include acetylcholinesterase inhibitors, immunosuppressants, and plasmapheresis. Acetylcholinesterase inhibitors, like pyridostigmine, work by preventing the breakdown of acetylcholine, thereby improving communication between nerves and muscles. Immunosuppressants reduce the immune system's attack on acetylcholine receptors, while plasmapheresis removes harmful antibodies from the blood. These treatments are crucial for MG patients as they help alleviate muscle weakness and improve quality of life. Acupuncture, as studied in the trial, may modulate neurological and immune functions, potentially increasing acetylcholine receptor expression and offering an alternative or complementary approach to traditional treatments.

Acupuncture and somatic nerve stimulation: mechanism underlying effects on cardiovascular and renal activities.Comparative metabolomics study on therapeutic mechanism of electro-acupuncture and moxibustion on rats with chronic atrophic gastritis (CAG)."Warming yang and invigorating qi" acupuncture alters acetylcholine receptor expression in the neuromuscular junction of rats with experimental autoimmune myasthenia gravis.