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This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safely and effectively manage anxiety in Parkinson's Disease. Eligible subjects will receive either real or sham acupuncture THREE times weekly for a total of 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. |
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| Randomized Subjects receive a real acupuncture. | Active Comparator | Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture to treat anxiety in Parkinson disease | Other | Subjects will be randomized in a 1:1 ratio to receive sham acupuncture. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Hamilton Anxiety Scale (HAM-A) between the treatment group. | The primary outcome measure will be the change between the baseline visit and the SIX-week time point in the Hamilton Anxiety Scale (HAM-A) between the treatment group. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe. | SIX weeks |
| Change in the Generalized Anxiety Disorder 7-Item (GAD-7) scale between the treatment group. | The primary outcome measure will be the change between the baseline visit and the SIX-week time point in the Generalized Anxiety Disorder 7-Item (GAD-7) scale between the treatment group. Each item is scored on a scale of 0 (not at all) to 3 (Nearly Every Day), with a total score range of 0-56, where <4 indicates Minimal Anxiety, 5-9 Mild Anxiety, 10-14 Moderate Anxiety, and 15-21 Severe Anxiety. | SIX Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Unified Parkinson's Disease Rating Scale between the treatment group. | A comprehensive assessment of both motor and non-motor symptoms associated with Parkinson's. The Unified Parkinson's Disease Rating Scale is made up of 42 items. These items are divided into six sections which are separately "evaluation of mentation, behavior, and mood", "self-evaluation of the activities of daily life", "clinician-scored monitored motor evaluation", "complications of therapy", "Hoehn and Yahr staging of severity of Parkinson's disease" and "Schwab and England ADL scale". The evaluation score for the first item to the 39th item is 0 to 4 points. The evaluation score for the 40th to the 42th item is 0 to 1 points. The higher score means the worse condition. This scores indicate severe symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Jin Kim, Ph.D | Contact | 603-87055098 | neurokim@gmail.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| THREE months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |