The Effect of High Frequency Repetitive Transcranial Magnetic Stimulation on Depression in Parkinson's Disease
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 depression severity measurements
研究概览
简要总结
This study aims to assess the therapeutic role of rTMS on parkinson's patients with depression. Patients diagnosed with Parkinson's Disease and depression will be recruited. All patients will be admitted and will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS for left dorsolateral prefrontal cortex (DLPFC) for 10 consecutive sessions totally over period of 10 days with repeated booster sessions every month during the period of follow up. The other will receive sham sessions.
详细描述
This study aims to assess the therapeutic role of rTMS on parkinson's patients with depression. Thirty PD patients with depression using United Kingdom (UK ) bank criteria for PD will be recruited from outpatient clinic in Assiut University. All patients will be admitted at Neuropsychiatric Department, Assiut University Hospital/ Assiut, Egypt.Each patient fulfilled the inclusion criteria as having score more than or equal 14 on Beck Depression Inventory (BDI) will be recruited. 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 left DLPFC 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.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with Parkinson's Disease who were diagnosed according to UK bank criteria for PD, Aged 45-75 years, with criteria for depression (BDI > or = 14), and consent obtained from the patient or his caregiver.
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 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) exposure
- •Moderate and Severe depression (Hamilton Depression Rating Scale score >16)
- •severe dysautonomia
- •Cerebellar signs
- •Babinski sign
- •Strictly unilateral features after 3 years
- •Hydrocephalus or intracranial lesion on neuroimaging
- •We also excludes patients with intracranial metallic devices or with pacemakers or any other device.
- •patients with cognitive impairment (Mini-Mental Status Examination< 24)
研究组 & 干预措施
Real rTMS
Real rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses on the left DLPFC for 10 consecutive sessions totally over period of 10 days.
干预措施: repetitive transcranial magnetic stimulation (Device)
sham rTMS
Sham rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses with coil perpendicular on scalp over the occipital cortex for 10 consecutive sessions totally over period of 10 days.
干预措施: repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
changes in depression severity measurements
时间窗: three months
Depression severity changes measured by Hamilton Depression Rating Scale (HAMD)
次要结局
未报告次要终点
研究者
Asmaa Hasan
asmaa mohamed mohamed mahmoud hasan assistant lecturer
Assiut University