Meridian Activation Remedy System for Parkinson's Disease

Last updated: November 29, 2023
Sponsor: Korea Health Industry Development Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

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

Clinical Study ID

NCT05621772
DJ_PD_21_02
  • Ages 45-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 45 to 75 years of age
  2. Patients with PD, diagnosed according to the United Kingdom Parkinson's DiseasesSociety 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 signedthe informed consent form

Exclusion

Exclusion Criteria:

  1. Clinically unstable patients (e.g., elevated aspartate transaminase (AST) or alanineaminotransferase (ALT) more than three-fold the upper limit of normal in the researchinstitute'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 oxidaseB) inhibitor, etc.) according to a doctor's prescription within the last 4 weeks priorto enrollment
  6. Patients who are receiving manual therapy, exercise therapy, or rehabilitation therapyfor Parkinson's disease according to a doctor's prescription within the last 4 weeksprior 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 tothe judgment of the researcher

Study Design

Total Participants: 88
Treatment Group(s): 1
Primary Treatment: Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)
Phase:
Study Start date:
April 08, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

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

    Daejeon, 35235
    Korea, Republic of

    Active - Recruiting

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