Meridian Activation Remedy System for Parkinson's Disease

Parkinson Disease Clinical Trial

— MARS-PD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621772
• Other study ID #: DJ_PD_21_02
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Korea Health Industry Development Institute
• Contact: Miso S. Park, Prof. Dr.
• Phone: +82-42-470-9541
• Email: miso.sophia.park[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement Disorder Society Unified Parkinson's Disease Rating Scale Part ?	MDS-UPDRS Part ? (maximum: 132, minimum: 0; higher scores mean a worse outcome)	Change from baseline MDS-UPDRS Part ? score at 8 weeks
Secondary	Movement Disorder Society Unified Parkinson's Disease Rating Scale Part ?	MDS-UPDRS Part ?	Change from baseline MDS-UPDRS Part ? score at 4 and 12 weeks
Secondary	International Physical Activity Questionnaire Short Form	IPAQ	Change from baseline IPAQ score at 4, 8 and 12 weeks
Secondary	Parkinson Self Questionnaire	Parkinson Self Questionnaire, developed by researchers	Change from baseline Parkinson Self Questionnaire results at 4, 8 and 12 weeks
Secondary	Parkinson's disease Sleep Scale	PDSS	Change from baseline PDSS score at 4, 8 and 12 weeks
Secondary	Timed up and go test	TUG	Change from baseline TUG time in seconds at 8 and 12 weeks
Secondary	GAITRite Electronic Walkway Platinum	GAITRite	Change from baseline GAITRite parameters at 8 and 12 weeks
Secondary	Functional near-infrared spectroscopy	fNIRS	Change from baseline fNIRS results at 8 and 12 weeks
Secondary	Smart band outcomes	Number of steps per day	Change from baseline daily steps at 4, 8 and 12 weeks
Secondary	Iris imaging 1	Visible light image	Iris connective tissue texture, baseline
Secondary	Iris imaging 2	Infrared image	Iris connective tissue density, baseline
Secondary	Movement Disorder Society Unified Parkinson's Disease Rating Scale	MDS-UPDRS	Change from baseline MDS-UPDRS score at 4, 8 and 12 weeks
Secondary	Gut microbiome test	Gut microbiome diversity and composition, fecal samples	Change from baseline gut microbiome analysis results at 8 weeks