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
- 2
- 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
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)
- Gut microbiome test(Change from baseline gut microbiome analysis results at 8 weeks)
- GAITRite Electronic Walkway Platinum(Change from baseline GAITRite parameters at 8 and 12 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