Personalized Neuromodulation Treatment for Parkinson's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
研究概览
简要总结
Parkinsonian Syndromes (PDS) with predominant motor dysfunction include progressive supranuclear palsy (PSP), multiple system atrophy (MSA) and corticobasal degeneration (CBD). Current treatment options for PDS are extremely limited due to the less understanding of disease pathophysiology and lack of therapeutic targets. Combining the results of previous studies and our group's previous research, sixty qualified PDS patients would be enrolled to conduct a prospective single-center randomized sham controlled clinical trial to verify the new therapeutic options that can improve symptoms and effectively slow the progression of the disease.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Compliance with the MDS revised clinical diagnostic criteria for Parkinsonian syndrome (2015 edition)
- •aged >40 years and <80 years, regardless of gender.
- •Patients were relatively stable during the study period and remained stable on medication
- •Good compliance, written informed consent, and consent for NIBS long-term intervention treatment
排除标准
- •Patients with severe neuropsychiatric disorders or a previous history of severe neurologic conditions (e.g., epilepsy, cerebrovascular accident, etc.) or traumatic brain injury or brain surgery
- •inability to complete the questionnaire independently
- •Previous treatment with DBS or SCS; TMS or tDCS within 6 months
- •Severe physical illness and any physical condition that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases
- •Installation of intracranial stents, pacemakers, coronary stents, cochlear implants, and other human implantable materials
- •is currently taking other investigational drugs or is participating in other clinical trials
- •Any other condition that the investigator believes makes him or her unsuitable for participation in this study.
结局指标
主要结局
Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
时间窗: 6 weeks
Compare the changes in UPDRS scores from baseline to post- treatment in the three intervention groups (UPDRS part3: range 0\~72, higher score is related to a worse outcome).
次要结局
- Group differences of Progressive Supranuclear Palsy Rating Scale (PSPRS)(6 weeks)
- Group differences of Berg Balance Scale (BBS) changes(6 weeks)
- Group differences of Unified Multiple System Atrophy Rating Scale (UMSARS)(6 weeks)
- Group differences of Hamilton depression scale-17 (HAMD-17) changes(6 weeks)
- Group differences of Cortical Basal ganglia Functional Scale (CBFS)(6 weeks)
- Group differences of Hamilton Anxiety Scale (HAMA) changes(6 weeks)
- Group differences of Mini-mental State Examination (MMSE) changes(6 weeks)
- Group differences of Montreal Cognitive Assessment (MoCA) changes(6 weeks)
- Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes(6 weeks)
- Group differences of Standardized Swallowing Assessment (SSA) changes(6 weeks)
- Group differences of Wexner scores changes(6 weeks)
- Group differences of adverse event(6 weeks)