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Parkinson DiseaseMARS-PDNCT05621772

Meridian Activation Remedy System for Parkinson's Disease

A study testing Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) in people with Parkinson Disease, run by Korea Health Industry Development Institute at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Parkinson Disease
What is being tested?
Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteSouth Korea
Study dates
8 Apr 2022to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University

    Daejeon, 35235

Other trials in South Korea

About this study

Official title: 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.

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.

Being tested
Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05621772
Study groupRoleWhat they receive
Experimental group (Meridian Activation Remedy System for Parkinson's Disease)ExperimentalMeridian Activation Remedy System for Parkinson's Disease (MARS-PD) treatment (16 times/8 weeks total, 2 times/week)
Receives: Other: Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)
Control group (Usual Care)No interventionUsual 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 being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (12)

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

    MDS-UPDRS Part Ⅲ

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

  2. International Physical Activity Questionnaire Short Form

    IPAQ

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

  3. Parkinson Self Questionnaire

    Parkinson Self Questionnaire, developed by researchers

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

  4. Parkinson's disease Sleep Scale

    PDSS

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

  5. Timed up and go test

    TUG

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

  6. GAITRite Electronic Walkway Platinum

    GAITRite

    Measured: Change from baseline GAITRite parameters at 8 and 12 weeks

  7. Functional near-infrared spectroscopy

    fNIRS

    Measured: Change from baseline fNIRS results at 8 and 12 weeks

  8. Smart band outcomes

    Number of steps per day

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

  9. Iris imaging 1

    Visible light image

    Measured: Iris connective tissue texture, baseline

  10. Iris imaging 2

    Infrared image

    Measured: Iris connective tissue density, baseline

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

    MDS-UPDRS

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

  12. Gut microbiome test

    Gut microbiome diversity and composition, fecal samples

    Measured: Change from baseline gut microbiome analysis results at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start8 Apr 2022
  3. Primary completion3 Jul 2025
  4. Study completion31 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621772
Sponsor's protocol ID
DJ_PD_21_02
Acronym
MARS-PD
Status last verified
Jul 2025
First submitted
4 Nov 2022
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) in people with Parkinson Disease, run by Korea Health Industry Development Institute at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ (time frame: Change from baseline MDS-UPDRS Part Ⅲ score at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621772, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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