Standardization and Optimization of TMS Protocols for the Treatment of Early and Mild-to-late Stage Parkinson's Disease With Depression or Cognitive Impairment
试验速览
- 阶段
- 不适用
- 入组人数
- 252
- 试验地点
- 10
- 主要终点
- Hamilton Depression Scale（HAMD）
研究概览
简要总结
The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in Parkinson's disease patients with depression or cognitive impairment. The study consists of seven total visits to all. Compensation will be provided for each visit.
详细描述
Transcranial magnetic stimulation(TMS) is a valuable non-invasive brain stimulation tool for interventional neurophysiology applications, which generate local current and modulates brain activity in a specific, cortico-subcortical network. Repetitive TMS (rTMS) is developed as it is safe and well-tolerated. The left dorsolateral prefrontal cortex (DLPFC) high-frequency rTMS treatment has been proved effective for depression by many clinical studies,as well as the low-frequency rTMS over the right DLPFC. In Europe, guidelines on the therapeutic use of rTMS was published in 2014, in which they pointed out that high-frequency rTMS over left DLPFC could be used as therapeutic method for dPD, with a B-level recommendation. Among several small and pilot studies of rTMS in PD patients, rTMS over either the motor cortex or DLPFC has been reported to show beneficial effects on cognitive impairment with no serious adverse events.However, the relative effectiveness of rTMS over left or right prefrontal, or both regions on both depression and cognitive impairment symptoms, has yet to be established in PD patients.
The investigators propose to conduct a ten-center, blinded, sham-controlled, randomized, parallel-group study of fixed-dose, high-frequency and/or low-frequency rTMS in 252 PD patients who are experiencing depressive symptoms or cognitive impairment. Subjects will be randomized to receive rTMS over right and left DLPFC, both or neither active/sham rTMS. Subjects will receive rTMS for 45 minutes treatment over a 2-week period, all subjects will undergo a comprehensive assessment of mood, cognition, motor and quality of life before and after the last rTMS treatment, and after 2,4 and 12 weeks post-treatment. This study directly addresses the expansion of rTMS as an alternative treatment for depression and cognitive impairment in the PD population.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old and ≤ 80 years old, male or female
- •Subjects with idiopathic PD (according to Movement Disorder Society Clinical Diagnostic Criteria，both clinically established PD and clinically probable PD)
- •Subjects fulfilling the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition(DSM-IV)
- •Did not use antidepressant(s) for a minimum of 2 months
- •Untreated or had stabilized doses of anti-Parkinson's disease medication for > 28 days, and maintain this dose during treatment
- •Subjects or their legal representatives could follow the research plan, visit plan
- •Subjects or their legal guardians agree to participate in the trial and signs informed consent
排除标准
- •Subjects with Parkinson's plus syndrome(PPS) or Secondary Parkinson Disease caused by vascular factors, toxins, and drugs
- •Subjects with persistent head tremor
- •Subjects with dementia
- •Subjects with suicidal tendency and psychotic symptoms
- •Subjects with consciousness, history of stroke, severe neurological/psychiatric disorders such as transient ischemic attack within 1 year prior to screening (Visit 1), or other severe organic diseases
- •Accepted deep brain stimulation(DBS) or other invasive brain surgery previously
- •Subjects with contraindications for repetitive transcranial magnetic stimulation(rTMS), such as history of epileptic seizures, pregnant, implantation of pacemaker or other metal implants in the body, intracranial hypertension, severe hemorrhagic tendency, etc.
结局指标
主要结局
Hamilton Depression Scale（HAMD）
时间窗: 3 months
The Hamilton Depression Rating Scale (HAMD) is a 24-item interviewer administered structure questionaire designed to assess symptoms of depression. Items are scored with a range of 0-4, though 11 of the items are scored between 0 and 2. A total score is then calculated of all items which can range from 0 to 74. A higher score is indicative of more depressive symptoms, and a lower score post-tx is indicative of better outcome.
Beck Depression Inventory（BDI）
时间窗: 3 months
The Beck Depression Inventory (BDI) is a 21-item self-report questionaire that measures depressive symptoms. Each item is scored on a scale of 0-3, and items are summated to yield a total score. A higher score is indicative of greater symptoms of depression. Total scores may range between 0 and 63. A score greater than or equal of 14 is suggestive of clinically significant symptoms.
次要结局
- Mini-mental State Examination（MMSE）(3 months)
- Montreal Cognitive Assessment Scale（MoCA）(3 months)
- Named test of the Aphasia Battery of Chinese(3 months)
- Similarity test(3 months)
- Symbol Digit modalities test（SDMT）(3 months)
- Verbal fluency test（VFT）(3 months)
- Logical memory test（LMT）(3 months)
- Delayed memory test（DMT）(3 months)
- Digit span test（DST）(3 months)
- Ten point clock test(3 months)
- Uniform Parkinson's Disease Rating Scale Ⅲ（UPDRSⅢ）(3 months)
- Modified Hoehn & Yahr scale（H-Y）(3 months)
- Time up and go test（TUG test）(3 months)
- Activity of Daily Living Scale（ADL）(3 months)
- Parkinson's Disease Questionnaire（PDQ-39）(3 months)
- Non-motor symptoms questionnaire(NMS-Q)(3 months)
- Pittsburgh Sleep Quality Index (PSQI)(3 months)
- Hamilton Anxiety Scale（HAMA）(3 months)
- Beck Anxiety Inventory（BAI）(3 months)