Meridian Activation Remedy System for Parkinson's Disease

NCT05621772 | Completed DMC

• 1 other identifier: DJ_PD_21_02
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

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)

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

Secondary Outcomes (12)

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

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

• International Physical Activity Questionnaire Short Form

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

• Parkinson Self Questionnaire

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

• Parkinson's disease Sleep Scale

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

• Timed up and go test

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

Study Arms (2)

Experimental group (Meridian Activation Remedy System for Parkinson's Disease)

EXPERIMENTAL

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)

Control group (Usual Care)

NO INTERVENTION

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

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.

Experimental group (Meridian Activation Remedy System for Parkinson's Disease)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Health Industry Development Institute: lead

Study Sites (1)

Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University

Daejeon, 35235, South Korea

Location

Related Publications (1)

• 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.

  PMID: 38709746 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ho Ryong Yoo, Prof. Dr.

  Daejeon University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: A Single-center, Rater-blinded, Parallel Randomized Controlled Trial

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 18, 2022
• Study Start: April 8, 2022
• Primary Completion: July 3, 2025
• Study Completion: July 31, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)