Meridian Activation Remedy System for Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Other: Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)

• Registration Number: NCT05621772
• Lead Sponsor: Korea Health Industry Development Institute

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.

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.

Study Timeline

• Study Start: 2022-04-08
• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-04
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (Meridian Activation Remedy System for Parkinson's Disease)	Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)	Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) treatment (16 times/8 weeks total, 2 times/week)

Primary Outcome Measures

Name	Time	Method
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ	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 Outcome Measures

Name	Time	Method
Parkinson's disease Sleep Scale	Change from baseline PDSS score at 4, 8 and 12 weeks	PDSS
Smart band outcomes	Change from baseline daily steps at 4, 8 and 12 weeks	Number of steps per day
Iris imaging 1	Iris connective tissue texture, baseline	Visible light image
Movement Disorder Society Unified Parkinson's Disease Rating Scale	Change from baseline MDS-UPDRS score at 4, 8 and 12 weeks	MDS-UPDRS
International Physical Activity Questionnaire Short Form	Change from baseline IPAQ score at 4, 8 and 12 weeks	IPAQ
Parkinson Self Questionnaire	Change from baseline Parkinson Self Questionnaire results at 4, 8 and 12 weeks	Parkinson Self Questionnaire, developed by researchers
Iris imaging 2	Iris connective tissue density, baseline	Infrared image
GAITRite Electronic Walkway Platinum	Change from baseline GAITRite parameters at 8 and 12 weeks	GAITRite
Gut microbiome test	Change from baseline gut microbiome analysis results at 8 weeks	Gut microbiome diversity and composition, fecal samples
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ	Change from baseline MDS-UPDRS Part Ⅲ score at 4 and 12 weeks	MDS-UPDRS Part Ⅲ
Functional near-infrared spectroscopy	Change from baseline fNIRS results at 8 and 12 weeks	fNIRS
Timed up and go test	Change from baseline TUG time in seconds at 8 and 12 weeks	TUG

Trial Locations

Locations (1)

Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University; 🇰🇷 Daejeon, Korea, Republic of