Acupuncture for Anxiety in Parkinson's Disease

NCT ID: NCT04729010

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Randomized Subjects receive a sham acupuncture.

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

Group Type SHAM_COMPARATOR

Acupuncture to treat anxiety in Parkinson disease

Intervention Type OTHER

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

Randomized Subjects receive a real acupuncture.

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

Group Type ACTIVE_COMPARATOR

Acupuncture to treat anxiety in Parkinson disease

Intervention Type OTHER

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

Interventions

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Acupuncture to treat anxiety in Parkinson disease

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiamen University

OTHER

Sponsor Role lead

Responsible Party

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Kim Yun Jin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yun Jin Kim, Ph.D

Role: CONTACT

603-87055098

Other Identifiers

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ITCM0005

Identifier Type: -

Identifier Source: org_study_id

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