An Evaluation of Transcranial Magnetic Stimulation in the National Health Service
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score
研究概览
简要总结
This research programme purports to test the effectiveness of two Transcranial Magnetic Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI) scans to improve the localization of TMS targets.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of depressive disorder (DSM-IV)
- •Diagnosis of treatment resistance (at least stage 1 as defined by Thase & Rush, 1997 for depression)
- •Female or male between 18 and 70 years
排除标准
- •History of Bipolar disorder
- •Clinically relevant neurological comorbidity such as brain neoplasm, cerebral vascular events, epilepsy, neurodegenerative disorders, prior brain surgery
- •Metal objects in and around body that cannot be removed
- •Pregnancy
- •Cardiac pacemaker or implanted medication pump
- •Major unstable medical illness
- •Change in prescribed medication in the 2 weeks preceding the start of TMS trial
- •Current alcohol/stimulant dependence with propensity for toxic/withdrawal seizures
研究组 & 干预措施
Theta-Burst Stimulation
Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)
干预措施: Theta-Burst Stimulation (Device)
High Frequency stimulation
High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex.
干预措施: High frequency stimulation (Device)
结局指标
主要结局
Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score
时间窗: 4 weeks
次要结局
- Mean change in Beck Depression Inventory scores(4 weeks)
研究者
Sudheer Lankappa
Consultant Psychiatrist
Institute of Mental Health Nottingham