Back to results

Acupuncture in Myasthenia Gravis (AcuMG)

Primary Purpose

Myasthenia Gravis

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional treatment trial for Myasthenia Gravis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

HealthPartners Neuroscience Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Start

Delayed start

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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

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]

Full Information

NCT ID

NCT05230082

First Posted

January 28, 2022

Last Updated

October 11, 2023

Sponsor

HealthPartners Institute

1. Study Identification

Unique Protocol Identification Number

NCT05230082

Brief Title

Acupuncture in Myasthenia Gravis (AcuMG)

Official Title

Acupuncture Treatment for Individuals With Myasthenia Gravis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 25, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HealthPartners Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myasthenia Gravis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immediate Start

Arm Type

Experimental

Arm Description

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

Arm Title

Delayed start

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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]

Time Frame

pre/post - 12 weeks

Secondary Outcome Measure Information:

Title

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

Description

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]

Time Frame

pre/post - 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amanda A Herrmann, PhD

Organizational Affiliation

HealthPartners Neuroscience Research

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gaurav K Guliani, MD

Organizational Affiliation

HealthPartners Neurology

Official's Role

Principal Investigator

Facility Information:

Facility Name

HealthPartners Neuroscience Center

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55130

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Acupuncture in Myasthenia Gravis (AcuMG)

We'll reach out to this number within 24 hrs