Acupuncture in Myasthenia Gravis (AcuMG)

Not Applicable

Completed

• Conditions: Myasthenia Gravis
• Interventions: Other: Acupuncture

• Registration Number: NCT05230082
• Lead Sponsor: HealthPartners Institute

Brief Summary

The purpose of the study is to determine the effect acupuncture treatment on individuals with a diagnosis of Myasthenia Gravis (MG). A total of 20 people with MG will be enrolled in this study to receive acupuncture treatment 2 times a week for 12 weeks. Participants will be randomized into two groups: 1) Immediate start and 2) Delayed start (12 weeks). The delayed start group will act as a control group for the first 12 weeks, but then receive acupuncture treatment for 12 weeks. It is hypothesized that patients with MG who receive acupuncture treatment will have improved quality of life and activities of daily living compared to no treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-08
• Study Start: 2022-05-25
• Status Verified: 2024-02
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Ability to provide and provision of signed and dated informed consent form
• Age 18-80
• Diagnosis of MG

Exclusion Criteria

• Non-English speaking
• Participation in acupuncture treatment outside of the study, while enrolled
• History of any other serious neurological, psychiatric, chronic pain disorders, or seizures
• History of bleeding diathesis, other bleeding disorders, or syncope with needle puncture
• History of cardiac arrhythmia or current pacemaker, neurostimulator, or other implanted stimulation device
• Recent or active substance use disorder
• Women who are currently pregnant, lactating, or planning to become pregnant during the study
• Any other medical conditions that could affect their ability to participate in acupuncture treatments for the study duration (as determined by study investigators)
• Active participation or past participation ≤3 months in any other interventional study.
• Unwilling to participate in all study related activities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Start	Acupuncture	Patients will receive acupuncture treatment two times per week for 12 weeks.
Delayed start	Acupuncture	Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
To determine the effect of acupuncture on quality of life in patients with MG	pre/post - 12 weeks	A brief 15-item disease specific questionnaire. Myasthenia gravis-quality of life 15 (MG-QOL15). A higher score indicates a lower quality of life.\[range: 0-30\]

Secondary Outcome Measures

Name	Time	Method
To determine the effect of acupuncture on activities of daily living in patients with MG	pre/post - 12 weeks	A brief 8-item disease specific questionnaire. Myasthenia gravis-activities of daily living (MG-ADL). A higher score indicates activities of daily living are more difficult.\[range: 0-24\]

Trial Locations

Locations (1)

HealthPartners Neuroscience Center; 🇺🇸 Saint Paul, Minnesota, United States