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Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)
Sponsored by
Korea Health Industry Development Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

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

Inclusion Criteria: 45 to 75 years of age Patients with PD, diagnosed according to the United Kingdom Parkinson's Diseases Society Brain Bank Criteria Hoehn and Yahr scale stage I to III Patients who have voluntarily decided to participate in the clinical study and signed the informed consent form Exclusion Criteria: Clinically unstable patients (e.g., elevated aspartate transaminase (AST) or alanine aminotransferase (ALT) more than three-fold the upper limit of normal in the research institute's laboratory, heart failure, respiratory failure, etc.) Patients who are planning to undergo deep brain stimulation within the study period Pregnant or lactating women Patients with MMSE-K (Mini-Mental State Exam) score of 18 or less If there has been a change in the dosage of antiparkinsonian drugs (e.g., L-dopa, COMT (catechol-O-methyltransferase) inhibitor, Dopamine agonist, MAO-B (monoamine oxidase B) inhibitor, etc.) according to a doctor's prescription within the last 4 weeks prior to enrollment Patients who are receiving manual therapy, exercise therapy, or rehabilitation therapy for Parkinson's disease according to a doctor's prescription within the last 4 weeks prior to enrollment, or are planning to receive such therapy within the study period Patients who are not suitable for participation in this clinical study according to the judgment of the researcher

Sites / Locations

  • Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group (Meridian Activation Remedy System for Parkinson's Disease)

Control group (Usual Care)

Arm Description

Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) treatment (16 times/8 weeks total, 2 times/week)

Usual care (all participants will be allowed to continue their prescribed medication and treatment (except Korean Medicine therapy), and they will not receive any additional treatment or therapy in the research institute), and lifestyle advice (all participants will receive a smart band and application-based guidance about their lifestyle)

Outcomes

Primary Outcome Measures

Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ
MDS-UPDRS Part Ⅲ (maximum: 132, minimum: 0; higher scores mean a worse outcome)

Secondary Outcome Measures

Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ
MDS-UPDRS Part Ⅲ
International Physical Activity Questionnaire Short Form
IPAQ
Parkinson Self Questionnaire
Parkinson Self Questionnaire, developed by researchers
Parkinson's disease Sleep Scale
PDSS
Timed up and go test
TUG
GAITRite Electronic Walkway Platinum
GAITRite
Functional near-infrared spectroscopy
fNIRS
Smart band outcomes
Number of steps per day
Iris imaging 1
Visible light image
Iris imaging 2
Infrared image

Full Information

First Posted
November 4, 2022
Last Updated
November 17, 2022
Sponsor
Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05621772
Brief Title
Meridian Activation Remedy System for Parkinson's Disease
Acronym
MARS-PD
Official Title
MARS-PD: Meridian Activation Remedy System for Parkinson's Disease - A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea Health Industry Development Institute

4. Oversight

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

5. Study Description

Brief Summary
In this study, the investigators aim to evaluate the clinical efficacy and cost-effectiveness of MARS-PD. Conventional, usual care will be used as the comparator because this trial aims to assess the add-on effect of MARS-PD. The investigators hypothesize that the complex therapy will relieve motor and nonmotor symptoms, improve gait performance, and enhance neuroplasticity in PD patients, and will be safe and cost-effective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group (Meridian Activation Remedy System for Parkinson's Disease)
Arm Type
Experimental
Arm Description
Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) treatment (16 times/8 weeks total, 2 times/week)
Arm Title
Control group (Usual Care)
Arm Type
No Intervention
Arm Description
Usual care (all participants will be allowed to continue their prescribed medication and treatment (except Korean Medicine therapy), and they will not receive any additional treatment or therapy in the research institute), and lifestyle advice (all participants will receive a smart band and application-based guidance about their lifestyle)
Intervention Type
Other
Intervention Name(s)
Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)
Intervention Description
MARS-PD is a complex therapy developed by researchers to enhance the synergistic effects of acupuncture and exercise.
Primary Outcome Measure Information:
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ
Description
MDS-UPDRS Part Ⅲ (maximum: 132, minimum: 0; higher scores mean a worse outcome)
Time Frame
Change from baseline MDS-UPDRS Part Ⅲ score at 8 weeks
Secondary Outcome Measure Information:
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ
Description
MDS-UPDRS Part Ⅲ
Time Frame
Change from baseline MDS-UPDRS Part Ⅲ score at 4 and 12 weeks
Title
International Physical Activity Questionnaire Short Form
Description
IPAQ
Time Frame
Change from baseline IPAQ score at 4, 8 and 12 weeks
Title
Parkinson Self Questionnaire
Description
Parkinson Self Questionnaire, developed by researchers
Time Frame
Change from baseline Parkinson Self Questionnaire results at 4, 8 and 12 weeks
Title
Parkinson's disease Sleep Scale
Description
PDSS
Time Frame
Change from baseline PDSS score at 4, 8 and 12 weeks
Title
Timed up and go test
Description
TUG
Time Frame
Change from baseline TUG time in seconds at 8 and 12 weeks
Title
GAITRite Electronic Walkway Platinum
Description
GAITRite
Time Frame
Change from baseline GAITRite parameters at 8 and 12 weeks
Title
Functional near-infrared spectroscopy
Description
fNIRS
Time Frame
Change from baseline fNIRS results at 8 and 12 weeks
Title
Smart band outcomes
Description
Number of steps per day
Time Frame
Change from baseline daily steps at 4, 8 and 12 weeks
Title
Iris imaging 1
Description
Visible light image
Time Frame
Iris connective tissue texture, baseline
Title
Iris imaging 2
Description
Infrared image
Time Frame
Iris connective tissue density, baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 45 to 75 years of age Patients with PD, diagnosed according to the United Kingdom Parkinson's Diseases Society Brain Bank Criteria Hoehn and Yahr scale stage I to III Patients who have voluntarily decided to participate in the clinical study and signed the informed consent form Exclusion Criteria: Clinically unstable patients (e.g., elevated aspartate transaminase (AST) or alanine aminotransferase (ALT) more than three-fold the upper limit of normal in the research institute's laboratory, heart failure, respiratory failure, etc.) Patients who are planning to undergo deep brain stimulation within the study period Pregnant or lactating women Patients with MMSE-K (Mini-Mental State Exam) score of 18 or less If there has been a change in the dosage of antiparkinsonian drugs (e.g., L-dopa, COMT (catechol-O-methyltransferase) inhibitor, Dopamine agonist, MAO-B (monoamine oxidase B) inhibitor, etc.) according to a doctor's prescription within the last 4 weeks prior to enrollment Patients who are receiving manual therapy, exercise therapy, or rehabilitation therapy for Parkinson's disease according to a doctor's prescription within the last 4 weeks prior to enrollment, or are planning to receive such therapy within the study period Patients who are not suitable for participation in this clinical study according to the judgment of the researcher
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miso S. Park, Dr.
Phone
+82-42-470-9555
Email
miso.sophia.park@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Ryong Yoo, Prof. Dr.
Phone
+82-42-470-9131
Email
hryoo@dju.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Ryong Yoo, Prof. Dr.
Organizational Affiliation
Daejeon University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University
City
Daejeon
ZIP/Postal Code
35235
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miso S. Park, Dr.
Phone
+82-42-470-9555
Email
miso.sophia.park@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Meridian Activation Remedy System for Parkinson's Disease

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