Skip to main content
OpenTrials
Completed

NCT Number: NCT05621772

Meridian Activation Remedy System for Parkinson's Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University

Daejeon, 35235, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

    MDS-UPDRS Part Ⅲ (maximum: 132, minimum: 0; higher scores mean a worse outcome)

Secondary outcomes

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

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

    MDS-UPDRS Part Ⅲ

  2. International Physical Activity Questionnaire Short Form

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

    IPAQ

  3. Parkinson Self Questionnaire

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

    Parkinson Self Questionnaire, developed by researchers

  4. Parkinson's disease Sleep Scale

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

    PDSS

  5. Timed up and go test

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

    TUG

  6. GAITRite Electronic Walkway Platinum

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

    GAITRite

  7. Functional near-infrared spectroscopy

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

    fNIRS

  8. Smart band outcomes

    Time frame: Change from baseline daily steps at 4, 8 and 12 weeks

    Number of steps per day

  9. Iris imaging 1

    Time frame: Iris connective tissue texture, baseline

    Visible light image

  10. Iris imaging 2

    Time frame: Iris connective tissue density, baseline

    Infrared image

  11. Movement Disorder Society Unified Parkinson's Disease Rating Scale

    Time frame: Change from baseline MDS-UPDRS score at 4, 8 and 12 weeks

    MDS-UPDRS

  12. Gut microbiome test

    Time frame: Change from baseline gut microbiome analysis results at 8 weeks

    Gut microbiome diversity and composition, fecal samples

Sponsors and collaborators

Lead sponsor

Korea Health Industry Development Institute

Other Gov

Registry information

Official study title

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

Acronym: MARS-PD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2022
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.