- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05230082
Acupuncture in Myasthenia Gravis (AcuMG)
September 2, 2025 updated by: HealthPartners Institute
Acupuncture Treatment for Individuals With Myasthenia Gravis
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55130
- HealthPartners Neuroscience Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Start
Patients will receive acupuncture treatment two times per week for 12 weeks.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To Determine the Effect of Acupuncture on Quality of Life in Patients With MG
Time Frame: pre-acupuncture treatment and post-acupuncture treatment
|
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]
|
pre-acupuncture treatment and post-acupuncture treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To Determine the Effect of Acupuncture on Activities of Daily Living in Patients With MG
Time Frame: pre-acupuncture treatment and post-acupuncture treatment
|
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]
|
pre-acupuncture treatment and post-acupuncture treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amanda A Herrmann, PhD, HealthPartners Neuroscience Research
- Principal Investigator: Gaurav K Guliani, MD, HealthPartners Neurology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2022
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
April 30, 2024
Study Registration Dates
First Submitted
January 28, 2022
First Submitted That Met QC Criteria
January 28, 2022
First Posted (Actual)
February 8, 2022
Study Record Updates
Last Update Posted (Estimated)
September 18, 2025
Last Update Submitted That Met QC Criteria
September 2, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neuromuscular Diseases
- Autoimmune Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Neurodegenerative Diseases
- Paraneoplastic Syndromes, Nervous System
- Nervous System Neoplasms
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Myasthenia Gravis
- Therapeutics
- Complementary Therapies
- Acupuncture Therapy
Other Study ID Numbers
- A21-197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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