Acupuncture for Anxiety in Parkinson's Disease

NCT04729010 | Unknown

• 1 other identifier: ITCM0005
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Anxiety

Keywords

Acupuncture, Anxiety, Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in the Unified Parkinson's Disease Rating Scale between the treatment group.

  THREE months

Study Arms (2)

Randomized Subjects receive a sham acupuncture.

SHAM COMPARATOR

Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.

Other: Acupuncture to treat anxiety in Parkinson disease

Randomized Subjects receive a real acupuncture.

ACTIVE COMPARATOR

Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.

Other: Acupuncture to treat anxiety in Parkinson disease

Interventions

Acupuncture to treat anxiety in Parkinson disease OTHER

Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.

Randomized Subjects receive a real acupuncture.; Randomized Subjects receive a sham acupuncture.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiamen University: lead

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Central Study Contacts

Yun Jin Kim, Ph.D

CONTACT

603-87055098; neurokim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: May 1, 2024
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR