Acupuncture in Myasthenia Gravis (AcuMG)

Myasthenia Gravis Clinical Trial

Official title:

Acupuncture Treatment for Individuals With Myasthenia Gravis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05230082
• Other study ID #: A21-197
• Status: Completed
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	pre/post - 12 weeks
Secondary	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]	pre/post - 12 weeks