The Effect of High Frequency Repetitive Transcranial Magnetic Stimulation on Advancing Parkinson's Disease With Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- changes in dysphagia severity measurement
研究概览
简要总结
This study aims to assess the therapeutic role of rTMS on parkinson's patients with dysphagia. Thirty PD patients with dysphagia using UK bank criteria for PD will recruited from outpatient clinic in Assuit University. All patients were admitted at Neuropsychiatric Department, Assiut University Hospital/ Assiut, Egypt. Each patient fulfilled the inclusion criteria as spontaneous swallows should be identified clearly when patients cannot perform voluntary swallows using clinical examination test. The patients will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days with repeated booster session every month during the period of follow up among three months. The other will receive sham sessions. All subjects will be followed up by selected clinical rating scales at different intervals pre session, post 10 sessions, and after one, two and three months.
详细描述
This study aims to assess the therapeutic role of repetitive transcranial magnetic (rTMS) on parkinson's patients with dysphagia. Thirty PD patients with dysphagia using UK bank criteria for PD will recruited from outpatient clinic in Assuit University. All patients were admitted at, Neuropsychiatric Department, Assiut University Hospital/ Assiut, Egypt. Each patient fulfilled the inclusion criteria as spontaneous swallows should be identified clearly when patients cannot perform voluntary swallows using clinical examination test. The patients will be allocated randomly into two groups using closed envelops one of which will receive real sessions of high frequency rTMS (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days with repeated booster session every month during the period of follow up among three months. the other will receive sham sessions. All subjects after receiving the rTMS will be followed up by selected clinical rating scales at different intervals Pre session, post 10 sessions, after one, two and three months.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All parkinson's disease patients who were diagnosed according to UK bank criteria for PD, Aged 50-75 years, with dysphagia
排除标准
- •History of repeated head injury
- •History of repeated cerebrovascular strokes
- •History of defined encephalitis
- •Oculogyric crisis, supranuclear gaze palsy
- •Family history of more than one relative
- •History of drug intake as antipsychotics or MPTP exposure
- •Severe dementia, (MMSE < 23), Severe depression (H- D) < severe dysautonomia
- •Cerebellar signs
- •Babiniski sign
- •Strictly unilateral features after 3 years
- •Hydrocephalus or intracranial lesion on neuroimaging
- •We also excluded patients with intracranial metallic devices or with pacemakers or any other device.
- •Patients who were unable to give informed Consent because of severe anesthesia or cognitive deficit were not included.
结局指标
主要结局
changes in dysphagia severity measurement
时间窗: Three months
Dysphagia severity changes measured by Dysphagia Handicap Index (DHI)
次要结局
- swallowing changes pre and post 10 sessions using(ten days)