Clinical trial NCT05621772: Meridian Activation Remedy System for Parkinson's Disease
Official title: MARS-PD: Meridian Activation Remedy System for Parkinson's Disease - A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Korea Health Industry Development Institute
Sponsor class: OTHER_GOV
First posted: 2022-11-18
Enrollment: 88
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ
timeFrame: Change from baseline MDS-UPDRS Part Ⅲ score at 8 weeks
Secondary outcomes:
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ
timeFrame: Change from baseline MDS-UPDRS Part Ⅲ score at 4 and 12 weeks
measure: International Physical Activity Questionnaire Short Form
timeFrame: Change from baseline IPAQ score at 4, 8 and 12 weeks
measure: Parkinson Self Questionnaire
timeFrame: Change from baseline Parkinson Self Questionnaire results at 4, 8 and 12 weeks
measure: Parkinson's disease Sleep Scale
timeFrame: Change from baseline PDSS score at 4, 8 and 12 weeks
measure: Timed up and go test
timeFrame: Change from baseline TUG time in seconds at 8 and 12 weeks
measure: GAITRite Electronic Walkway Platinum
timeFrame: Change from baseline GAITRite parameters at 8 and 12 weeks
measure: Functional near-infrared spectroscopy
timeFrame: Change from baseline fNIRS results at 8 and 12 weeks
measure: Smart band outcomes
timeFrame: Change from baseline daily steps at 4, 8 and 12 weeks
measure: Iris imaging 1
timeFrame: Iris connective tissue texture, baseline
measure: Iris imaging 2
timeFrame: Iris connective tissue density, baseline
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale
timeFrame: Change from baseline MDS-UPDRS score at 4, 8 and 12 weeks
measure: Gut microbiome test
timeFrame: Change from baseline gut microbiome analysis results at 8 weeks
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University
Study officials:
affiliation: Daejeon University
name: Ho Ryong Yoo, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: