MARS-PD: Meridian Activation Remedy System for Parkinson's Disease - A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 to 75 years of age
- •Patients with PD, diagnosed according to the United Kingdom Parkinson's Diseases Society Brain Bank Criteria
- •Hoehn and Yahr scale stage I to III
- •Patients who have voluntarily decided to participate in the clinical study and signed the informed consent form
排除标准
- •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.)
- •Patients who are planning to undergo deep brain stimulation within the study period
- •Pregnant or lactating women
- •Patients with MMSE-K (Mini-Mental State Exam) score of 18 or less
- •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
- •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
- •Patients who are not suitable for participation in this clinical study according to the judgment of the researcher
研究组 & 干预措施
Experimental group (Meridian Activation Remedy System for Parkinson's Disease)
Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) treatment (16 times/8 weeks total, 2 times/week)
干预措施: Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) (Other)
Control group (Usual Care)
Usual care (all participants will be allowed to continue their prescribed medication and treatment (except Korean Medicine therapy), and they will not receive any additional treatment or therapy in the research institute), and lifestyle advice (all participants will receive a smart band and application-based guidance about their lifestyle)
结局指标
主要结局
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ
时间窗: 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)
次要结局
- Parkinson's disease Sleep Scale(Change from baseline PDSS score at 4, 8 and 12 weeks)
- Smart band outcomes(Change from baseline daily steps at 4, 8 and 12 weeks)
- Iris imaging 1(Iris connective tissue texture, baseline)
- Movement Disorder Society Unified Parkinson's Disease Rating Scale(Change from baseline MDS-UPDRS score at 4, 8 and 12 weeks)
- International Physical Activity Questionnaire Short Form(Change from baseline IPAQ score at 4, 8 and 12 weeks)
- Parkinson Self Questionnaire(Change from baseline Parkinson Self Questionnaire results at 4, 8 and 12 weeks)
- Iris imaging 2(Iris connective tissue density, baseline)
- GAITRite Electronic Walkway Platinum(Change from baseline GAITRite parameters at 8 and 12 weeks)
- Gut microbiome test(Change from baseline gut microbiome analysis results at 8 weeks)
- Movement Disorder Society Unified Parkinson's Disease Rating Scale Part Ⅲ(Change from baseline MDS-UPDRS Part Ⅲ score at 4 and 12 weeks)
- Functional near-infrared spectroscopy(Change from baseline fNIRS results at 8 and 12 weeks)
- Timed up and go test(Change from baseline TUG time in seconds at 8 and 12 weeks)
研究者
HoRyong Yoo
Prof. Dr.
Daejeon University