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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Subjects receive a sham acupuncture. | Sham Comparator | Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. |
|
| Randomized Subjects receive real acupuncture. | Active Comparator | Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups | The primary outcome measure will be the change between the baseline visit and 6-week time point in the Modified Fatigue Impact Scale Total (MFIS) between treatment groups. The range of the score is 0-84 with higher scores reflecting more severe fatigue. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benzi Kluger, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized Subjects Receive a Sham Acupuncture. | Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. Acupuncture to treat fatigue in Parkinson disease: Subjects will be randomized in a 1:1 ratio to receive sham acupuncture. |
| FG001 | Randomized Subjects Receive Real Acupuncture. | Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. Acupuncture: Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Subjects Receive a Sham Acupuncture. | Subjects were randomized in a 1:1 ratio to receive either real or sham acupuncture. Acupuncture to treat fatigue in Parkinson disease: Subjects will be randomized in a 1:1 ratio to receive sham acupuncture. |
| BG001 | Randomized Subjects Receive Real Acupuncture. |
| 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 | Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups | The primary outcome measure will be the change between the baseline visit and 6-week time point in the Modified Fatigue Impact Scale Total (MFIS) between treatment groups. The range of the score is 0-84 with higher scores reflecting more severe fatigue. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
12 weeks
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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 | Randomized Subjects Receive a Sham Acupuncture. | Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. Acupuncture to treat fatigue in Parkinson disease: Subjects will be randomized in a 1:1 ratio to receive sham acupuncture. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | Systematic Assessment | temporary increase in constipation, resolved with cessation of acupuncture |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benzi Kluger | University of Colorado School of Medicine | 3037242194 | benzi.kluger@ucdenver.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Acupuncture to treat fatigue in Parkinson disease | Other | Subjects will be randomized in a 1:1 ratio to receive sham acupuncture. |
|
Subjects were randomized in a 1:1 ratio to receive either real or sham acupuncture. Acupuncture: Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes |
| 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 |
|
| Region of Enrollment | Number | count of participants |
|
| Modified Fatigue Impact Scale Total | The range of the score is 0-84 with higher scores reflecting more severe fatigue. | Mean | Standard Deviation | units on a scale |
|
| Unified Parkinson Disease Rating Scale (UPDRS)-Motor subscale | The range of the score is 0-108 with higher scores reflecting more severe motor dysfunction due to Parkinson's disease. | Mean | Standard Deviation | units on a scale |
|
Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
Acupuncture: Subjects will be randomized in a 1:1 ratio to receive real acupuncture.
Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes
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|
| 0 |
| 47 |
| 0 |
| 47 |
| 1 |
| 47 |
| EG001 | Randomized Subjects Receive Real Acupuncture. | Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. Acupuncture: Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes | 0 | 47 | 0 | 47 | 0 | 47 |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |