Meridian Activation Remedy System for Parkinson's Disease

Korea Health Industry Development Institute88 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

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

MARS-PD is a complex therapy developed by researchers to enhance the synergistic effects of acupuncture and exercise.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University

Daejeon, South Korea

Outcomes

Primary Outcomes

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)

Time frame: Change from baseline MDS-UPDRS Part Ⅲ score at 8 weeks

Secondary Outcomes

Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ

MDS-UPDRS Part Ⅲ

Time frame: Change from baseline MDS-UPDRS Part Ⅲ score at 4 and 12 weeks

International Physical Activity Questionnaire Short Form

IPAQ

Time frame: Change from baseline IPAQ score at 4, 8 and 12 weeks

Parkinson Self Questionnaire

Parkinson Self Questionnaire, developed by researchers

Time frame: Change from baseline Parkinson Self Questionnaire results at 4, 8 and 12 weeks

Parkinson's disease Sleep Scale

PDSS

Time frame: Change from baseline PDSS score at 4, 8 and 12 weeks

Timed up and go test

TUG

Time frame: Change from baseline TUG time in seconds at 8 and 12 weeks

GAITRite Electronic Walkway Platinum

GAITRite

Time frame: Change from baseline GAITRite parameters at 8 and 12 weeks

Functional near-infrared spectroscopy

fNIRS

Time frame: Change from baseline fNIRS results at 8 and 12 weeks

Data from ClinicalTrials.gov

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