Meridian Activation Remedy System for Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (Meridian Activation Remedy System for Parkinson's Disease)<br>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)<br>* MARS-PD is a complex therapy developed by researchers to enhance the synergistic effects of acupuncture and exercise.<br>|
| No Intervention: Control group (Usual Care)<br>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?
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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 |