Acupuncture in Myasthenia Gravis (AcuMG)

NCT ID: NCT05230082

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2024-04-30

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.

Conditions

Myasthenia Gravis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate Start

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

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.

Delayed start

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

Group Type: ACTIVE_COMPARATOR

Acupuncture

Intervention Type: OTHER

Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.

Interventions

Acupuncture

Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda A Herrmann, PhD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Neuroscience Research

Gaurav K Guliani, MD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Neurology

Locations

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A21-197

Identifier Type: -

Identifier Source: org_study_id