NCT05621772

Meridian Activation Remedy System for Parkinson's Disease

MARS-PD: Meridian Activation Remedy System for Parkinson's Disease - A Single-center, Rater-blinded, Parallel Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Korea Health Industry Development Institute · Other Government
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	Meridian 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.

Timeline

• Start date: 2022-04-08
• Primary completion: 2025-07-03
• Completion: 2025-07-31
• First posted: 2022-11-18
• Last updated: 2025-08-05

Locations

1 site across 1 country: South Korea