NCT05230082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 18, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

January 28, 2022

Results QC Date

August 4, 2025

Last Update Submit

September 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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-acupuncture treatment and post-acupuncture treatment

Secondary Outcomes (1)

  • To Determine the Effect of Acupuncture on Activities of Daily Living in Patients With MG

    pre-acupuncture treatment and post-acupuncture treatment

Study Arms (2)

Immediate Start

EXPERIMENTAL

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

Other: Acupuncture

Delayed start

ACTIVE COMPARATOR

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

Other: Acupuncture

Interventions

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 startImmediate Start

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Amanda Herrmann, PhD
Organization
HealthPartners Institute Neuroscience Research Center

Study Officials

  • Amanda A Herrmann, PhD

    HealthPartners Neuroscience Research

    PRINCIPAL INVESTIGATOR
  • Gaurav K Guliani, MD

    HealthPartners Neurology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 8, 2022

Study Start

May 25, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

September 18, 2025

Results First Posted

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations