Acupuncture for Anxiety in Parkinson's Disease

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04729010
• Other study ID #: ITCM0005
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: May 2024

Study information

• Verified date: January 2021
• Source: Xiamen University
• Contact: Yun Jin Kim, Ph.D
• Phone: 603-87055098
• Email: neurokim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Parkinson Disease

Intervention

Other:
• Acupuncture to treat anxiety in Parkinson disease
Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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