Neuroprotective Effects of Intermittent Theta Burst Stimulation in Parkinson's Disease: a Delayed-start Randomized Double-blind Sham Controlled Study
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
Intermittent theta burst stimulation (iTBS) is an emerging non-invasive neuron regulation technique, which is widely used in neuropsychiatry for a variety of diseases and is widely accepted by patients due to its non-invasive, operable and relatively precise localization. Combining the results of previous studies and our group's previous research, sixty qualified PD patients would be enrolled to conduct a prospective single-center randomized double-blind sham controlled clinical trial to verify the long-term curative effects of iTBS treatment protocol and explore the neuron-protection of iTBS on neuronal loss of PD patients.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the revised clinical diagnostic criteria for Parkinson's disease of the Movement Disorder Society (MDS) International (2015 version).
- •aged >20 years and <80 years, regardless of gender.
- •2 ≤ Hoehn-Yahr stage≤
- •Maintain medication stability during the study period.
- •Good compliance, written informed consent, and consent for long-term interventional treatment with iTBS.
排除标准
- •Patients with severe neuropsychiatric disorders or previous history of severe neurological disorders (e.g., epilepsy, cerebrovascular accidents, etc.) or history of traumatic brain injury or brain surgery.
- •Patients with significant cognitive impairment (MMSE < 24) or inability to complete questionnaires independently.
- •Prior treatment with TMS, DBS or SCS.
- •Severe physical illness and any physical illness that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory disease.
- •Have human implantable materials such as intracranial stents, pacemakers, coronary stents, cochlear implants, etc.
- •Are currently taking other investigational drugs.
- •Any other condition that the investigator deems 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: 28 weeks
Compare the changes in UPDRS scores from baseline to post-iTBS in the four intervention groups (UPDRS part3: range 0\~72, higher score is related to a worse outcome).
次要结局
- Group differences of adverse event(28 weeks)
- Group differences of Hamilton Anxiety Scale (HAMA) changes(28 weeks)
- Group differences of Wexner changes(28 weeks)
- Group differences of Hamilton depression scale-17 (HAMD-17) changes(28 weeks)
- Group differences of Mini-mental State Examination (MMSE) changes(28 weeks)
- Group differences of Hoehn-Yahr stage(28 weeks)
- Group differences of 16-item Sniffin' Sticks test (SS-16) changes(28 weeks)
- Group differences of Montreal Cognitive Assessment (MoCA) changes(28 weeks)
- Group differences of Berg Balance Scale (BBS) changes(28 weeks)
- Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes(28 weeks)