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

MARS-PD: Meridian Activation Remedy System for Parkinson's Disease - A Single-center, Rater-blinded, Parallel Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)

Detailed Description

This study is a randomized controlled trial conducted at a single center with raters blinded to the intervention. We will look at the clinical effect of MARS-PD, consisting of 16 interventions over an 8-week period, in 88 individuals with Parkinson's disease. Patients will be assigned to either the experimental (n=44) or control (n=44) groups at random. he experimental group will receive the MARS intervention, while the control group will receive usual care only. The treatment duration is 8 weeks, followed by a 12-week follow-up. The primary outcome is the change in MDS-UPDRS Part III (Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III) score from baseline to 8 weeks. Secondary outcomes include assessments such as MDS-UPDRS, International Physical Activity Questionnaire Short Form, Parkinson Self Questionnaire, Parkinson's Disease Sleep Scale, Timed Up and Go test, GAITRite metrics, Functional Near-Infrared Spectroscopy measurements, smart band results, gut microbiome composition and diversity, and iris connective tissue texture.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ho Ryong Yoo, Prof. Dr.; Phone Number: +82-42-470-9131; Email: hryoo@dju.kr
• Study Contact Backup: Name: Miso S. Park, Prof. Dr.; Phone Number: +82-42-470-9541; Email: miso.sophia.park@gmail.com

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35235
    • Recruiting
    • Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University
    • Contact: Miso S. Park, Prof. Dr.; Phone Number: +82-42-470-9541; Email: miso.sophia.park@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 45 to 75 years of age
2. Patients with PD, diagnosed according to the United Kingdom Parkinson's Diseases Society Brain Bank Criteria
3. Hoehn and Yahr scale stage I to III
4. Patients who have voluntarily decided to participate in the clinical study and signed the informed consent form

Exclusion Criteria:

1. 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.)
2. Patients who are planning to undergo deep brain stimulation within the study period
3. Pregnant or lactating women
4. Patients with MMSE-K (Mini-Mental State Exam) score of 18 or less
5. 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
6. 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
7. Patients who are not suitable for participation in this clinical study according to the judgment of the researcher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group (Meridian Activation Remedy System for Parkinson's Disease); Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) treatment (16 times/8 weeks total, 2 times/week)	Other: Meridian Activation Remedy System for Parkinson's Disease (MARS-PD); MARS-PD is a complex therapy developed by researchers to enhance the synergistic effects of acupuncture and exercise.
No Intervention: Control group (Usual Care); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Change from baseline MDS-UPDRS Part Ⅲ score at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ	MDS-UPDRS Part Ⅲ	Change from baseline MDS-UPDRS Part Ⅲ score at 4 and 12 weeks
International Physical Activity Questionnaire Short Form	IPAQ	Change from baseline IPAQ score at 4, 8 and 12 weeks
Parkinson Self Questionnaire	Parkinson Self Questionnaire, developed by researchers	Change from baseline Parkinson Self Questionnaire results at 4, 8 and 12 weeks
Parkinson's disease Sleep Scale	PDSS	Change from baseline PDSS score at 4, 8 and 12 weeks
Timed up and go test	TUG	Change from baseline TUG time in seconds at 8 and 12 weeks
GAITRite Electronic Walkway Platinum	GAITRite	Change from baseline GAITRite parameters at 8 and 12 weeks
Functional near-infrared spectroscopy	fNIRS	Change from baseline fNIRS results at 8 and 12 weeks
Smart band outcomes	Number of steps per day	Change from baseline daily steps at 4, 8 and 12 weeks
Iris imaging 1	Visible light image	Iris connective tissue texture, baseline
Iris imaging 2	Infrared image	Iris connective tissue density, baseline
Movement Disorder Society Unified Parkinson's Disease Rating Scale	MDS-UPDRS	Change from baseline MDS-UPDRS score at 4, 8 and 12 weeks
Gut microbiome test	Gut microbiome diversity and composition, fecal samples	Change from baseline gut microbiome analysis results at 8 weeks

Collaborators and Investigators

• Sponsor: Korea Health Industry Development Institute
• Investigators: Principal Investigator: Ho Ryong Yoo, Prof. Dr., Daejeon University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: DJ_PD_21_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No