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CompletedNCT05621772MARS-PDUpdated Aug 5, 2025

Meridian Activation Remedy System for Parkinson's Disease

An interventional study of Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) in Parkinson Disease, sponsored by Korea Health Industry Development Institute. Completed at 1 site in South Korea. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Korea Health Industry Development Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2022, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 88 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Korea Health Industry Development Institute is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • OtherMeridian 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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. International Physical Activity Questionnaire Short Form

    IPAQ

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

  3. Parkinson Self Questionnaire

    Parkinson Self Questionnaire, developed by researchers

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

  4. Parkinson's disease Sleep Scale

    PDSS

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

  5. Timed up and go test

    TUG

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

  6. GAITRite Electronic Walkway Platinum

    GAITRite

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

  7. Functional near-infrared spectroscopy

    fNIRS

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

  8. Smart band outcomes

    Number of steps per day

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

  9. Iris imaging 1

    Visible light image

    Time frame: Iris connective tissue texture, baseline

  10. Iris imaging 2

    Infrared image

    Time frame: Iris connective tissue density, baseline

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

    MDS-UPDRS

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

  12. Gut microbiome test

    Gut microbiome diversity and composition, fecal samples

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

07

Study locations

1 site
  • Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University
    Daejeon, 35235, South Korea
08

References and documents

Publications

  • Hur WJ, Seo JW, Park MS, Yoo HR. Visual self-reporting for symptom communication in Parkinson's disease. Technol Health Care. 2026 Mar;34(2):287-299. doi: 10.1177/09287329251414326. Epub 2026 Feb 5. PubMed 41641966 ↗
  • Park MS, Park S, Kang JY, Jung IC, Yoo H. The efficacy and safety of MARS-PD: Meridian activation remedy system for Parkinson's disease-A single-center, assessor and statistician-blinded, parallel-group randomized, controlled trial protocol. PLoS One. 2024 May 6;19(5):e0303156. doi: 10.1371/journal.pone.0303156. eCollection 2024. PubMed 38709746 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05621772
Lead sponsor
Korea Health Industry Development Institute
Responsible party
HoRyong Yoo (Prof. Dr., Daejeon University) — Principal investigator
First posted
Nov 18, 2022
Start date
Apr 8, 2022
Primary completion
Jul 3, 2025
Completion
Jul 31, 2025
Last update
Aug 5, 2025

Study contacts

Ho Ryong Yoo, Prof. Dr.
principal investigator · Daejeon University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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