Acupuncture for Anxiety in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Acupuncture as a Symptomatic Treatment for Anxiety in Parkinson's Disease

Conditions
-----------------
Parkinson Disease, Anxiety

Intervention / Treatment
-----------------
* Other: Acupuncture to treat anxiety in Parkinson disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Parkinson's Disease by authorized Neurologist. Patients 40-75 years of age Patients who have significant anxiety symptom Patients must be on a stable medication regimen for the treatment of PD Exclusion Criteria: Patients who have had previous acupuncture within the past SIX months Patients with dementia, depression, or sleep disorder Patients who are currently taking medications known to affect anxiety

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Randomized Subjects receive a sham acupuncture.<br>Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. | Other: Acupuncture to treat anxiety in Parkinson disease<br>* Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.<br>|
| Active Comparator: Randomized Subjects receive a real acupuncture.<br>Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. | Other: Acupuncture to treat anxiety in Parkinson disease<br>* Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | THREE months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Anxiety, Parkinson's Disease