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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Start | Experimental | Patients will receive acupuncture treatment two times per week for 12 weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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-acupuncture treatment and post-acupuncture treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda A Herrmann, PhD | HealthPartners Neuroscience Research | Principal Investigator |
| Gaurav K Guliani, MD | HealthPartners Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Start | Patients will receive acupuncture treatment two times per week for 12 weeks. 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. Period 1: Acupuncture - Weeks 1-12 Period 2: No Acupuncture - Weeks 13-27 |
| FG001 | 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: 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. Period 1: No Acupuncture - Weeks 1-12 Period 2: Acupuncture - Weeks 13-24 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Weeks 1-12 |
| |||||||||||||
| Period 2: Weeks 13-24 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Start | Patients will receive acupuncture treatment two times per week for 12 weeks. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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] | Participants withdrew prior to the post-treatment measurement. | Posted | Mean | Standard Deviation | score on a scale | pre-acupuncture treatment and post-acupuncture treatment |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Start - Period 1 - Acupuncture Treatment | Patients will receive acupuncture treatment two times per week for 12 weeks. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroparesis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Herrmann, PhD | HealthPartners Institute Neuroscience Research Center | 651-495-6363 | Amanda.A.Herrmann@HealthPartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2023 | Aug 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| NOT COMPLETED |
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| BG001 | 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: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Time since MG Diagnosis | Mean | Standard Deviation | years |
|
| Diagnosis Classification | A base treatment of 21 needling points was used for all study participants. An unscored symptom severity scale was developed to help examine individual symptoms. Acupuncturists made a differential diagnosis to determine the diagnostic categories that were used to classify patterns of disharmony or imbalance within the body. Up to 9 additional points could be added to the base treatment, allowing for individual treatment. Yin - nourishment and repair functions Yang - defense and immune functions Stagnation pronounced - disruption in the flow of Qi (energy) and blood, often marked by pain. | Count of Participants | Participants |
|
| OG001 | 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: 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. |
|
|
| 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] | Participants withdrew prior to the post-treatment measurement. | Posted | Mean | Standard Deviation | score on a scale | pre-acupuncture treatment and post-acupuncture treatment |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 5 |
| 10 |
| EG001 | Immediate Start - Period 2 - No Intervention | Patients will receive acupuncture treatment two times per week for 12 weeks. 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. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | Delayed Start - Period 1 - No Intervention | Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks. 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. | 0 | 14 | 0 | 14 | 8 | 14 |
| EG003 | Delayed Start - Period 2 - Acupuncture Treatment | Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks. 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. | 0 | 14 | 0 | 14 | 0 | 14 |
| Needling pain/bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Sinus issues | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Sleep disturbances | General disorders | Non-systematic Assessment |
|
| COVID-19 | General disorders | Non-systematic Assessment |
|
| Gastrointestinal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Eye Tearing | Eye disorders | Non-systematic Assessment |
|
| Vaccine Reactions | General disorders | Non-systematic Assessment |
|
| Eye Ptosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hip Vibration Sensation | General disorders | Non-systematic Assessment |
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| Ear Infection | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Restless Leg | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Phantom Sensation | General disorders | Non-systematic Assessment |
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| Muscle Numbness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Eye Bruising | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Pneumonia and Flu | General disorders | Non-systematic Assessment |
|
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| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Post-treatment |
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