A Multicenter Clinical Study of rTMS for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Unified Parkinson's disease rating Scale （UPDRS）
研究概览
简要总结
Through rTMS, motor dysfunction and non-motor dysfunction of PD patients can be improved, working and living ability and quality of life of patients can be improved, and social burden and family burden can be reduced.
详细描述
According to the inclusion criteria, a total of 200 patients with Parkinson's disease were planned to be enrolled in each center, and randomly divided into control group (conventional treatment) and observation group (conventional treatment +rTMS) for a treatment cycle of 4 weeks. They were followed up for 3 months before treatment, 2 weeks and 4 weeks, respectively, after treatment, to evaluate the efficacy and function. The unified Parkinson's Disease Rating Scale (UPDRS) was used. Cognitive function assessment Monteller Cognitive Assessment Scale (MoCA); Barthel Index for daily living activities; Depression assessment Hamilton Depression Scale (HAMD); Hamilton Anxiety Scale (HAMA); Sleep assessment PD Sleep Scale (PDSS); Pain assessment King Parkinson's Pain Assessment (KPPS) and adverse events were recorded.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hoehn-YAHR classification is between 1 and 2；
- •Have a primary school education or above and can read the scale used in this study;
- •MoCA score between 20 and 24, mild cognitive impairment ;
- •Aged between 30 and 80, regardless of gender；
- •Voluntarily participate and sign informed consent.
排除标准
- •patients with cerebrovascular accident, craniocerebral injury and other diseases affecting muscle tension;
- •patients with serious mental disorders and cognitive disorders who cannot cooperate with assessment;
- •patients with severe liver, kidney, heart dysfunction and severe physical disorders;
- •Implanted devices such as pacemakers are installed inside the body;
- •drug-induced Parkinson's syndrome or Parkinson's superposition syndrome;
- •Have a history of epilepsy;
- •Women during pregnancy and breastfeeding.
结局指标
主要结局
Unified Parkinson's disease rating Scale （UPDRS）
时间窗: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
16 items, each with a score of 0-4, and the score is directly proportional to the severity of PD motor symptoms.
Montreal Cognitive Assessment Scale (MoCA)
时间窗: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Full score of 30 points,\>=26 points normal,. Mild cognitive impairment (MCI) on a scale of 18-26, moderate on a scale of 10-17, and severe on a scale of\<10.
King's Parkinson's Pain Assessment (KPPS)
时间窗: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Evaluate the pain degree and quality of life of patients with Parkinson's disease, including 14 items in 7 aspects, including skeletal muscle pain, Chronic pain, symptom fluctuation related pain, nocturnal pain, orofacial pain, distention pain, and nerve root pain. Each score is expressed as pain severity (0-3 levels) multiplied by frequency (0-4 levels), that is, 0-12 points. The total score is 168 points. The higher the score, the more severe the pain.
PD Sleep Scale (PDSS)
时间窗: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Evaluate the patient's sleep status, with a total of 15 items on the scale. Each item is scored on a scale of 0-10 points, with a lower score indicating poorer sleep status.
Activities of daily living Assessment - Barthel
时间窗: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
The total score of the index is 100 points, and the higher the score, the better the self-care ability and the less dependence. Those scoring above 60 can basically complete basic Activities of daily living, 59-41 need some help to complete, 40-21 need a lot of help. Those who score below 20 are in complete need of help and cannot take care of themselves.
次要结局
- Hamilton Depression Scale (HAMD)(The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.)
- Hamilton Anxiety Scale (HAMA)(The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.)