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Acupuncture for Anxiety in Parkinson's Disease

Primary Purpose

Parkinson Disease, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture to treat anxiety in Parkinson disease
Sponsored by
Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Acupuncture, Anxiety, Parkinson's Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    Randomized Subjects receive a sham acupuncture.

    Randomized Subjects receive a real acupuncture.

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 25, 2021
    Last Updated
    January 28, 2021
    Sponsor
    Xiamen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04729010
    Brief Title
    Acupuncture for Anxiety in Parkinson's Disease
    Official Title
    Acupuncture as a Symptomatic Treatment for Anxiety in Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xiamen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease, Anxiety
    Keywords
    Acupuncture, Anxiety, Parkinson's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Randomized Subjects receive a sham acupuncture.
    Arm Type
    Sham Comparator
    Arm Description
    Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
    Arm Title
    Randomized Subjects receive a real acupuncture.
    Arm Type
    Active Comparator
    Arm Description
    Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture to treat anxiety in Parkinson disease
    Intervention Description
    Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
    Primary Outcome Measure Information:
    Title
    Change in the Hamilton Anxiety Scale (HAM-A) between the treatment group.
    Description
    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.
    Time Frame
    SIX weeks
    Title
    Change in the Generalized Anxiety Disorder 7-Item (GAD-7) scale between the treatment group.
    Description
    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.
    Time Frame
    SIX Weeks
    Secondary Outcome Measure Information:
    Title
    Change in the Unified Parkinson's Disease Rating Scale between the treatment group.
    Description
    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.
    Time Frame
    THREE months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yun Jin Kim, Ph.D
    Phone
    603-87055098
    Email
    neurokim@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Acupuncture for Anxiety in Parkinson's Disease

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