The Antidepressant Effect of Right Temporal Kow Frequency rTMS Compared to Sham: A Clinical Controlled, Randomized, Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The total 17-item score on the Hamilton scale for depression
研究概览
简要总结
The aim of the present study is to compare the antidepressant effect of low frequency rTMS applied over the right temporal cortex with sham stimulation.
详细描述
TMS complies focal stimulation of the brain through a time varying magnetic field. Clinical controlled trials indicate that rTMS of the dorsolateral prefrontal cortex may have an antidepressant effect and no serious side effects. Several clinical controlled studies investigating the antidepressant effect of low as well as high frequency rTMS of the right and left prefrontal cortex have been carried out with varying results.Research on the issue suffer from small and selected study populations.There is a need for additional clinical controlled studies on larger samples and methodological investigations to clarify what is the optimal stimulus design for the treatment of depressed patients.
Recent research indicates that Depression is associated with an increased metabolic activity of subcortical areas especially the right hippocampus of the brain.
Remission of depression symptoms is associated with normalisation of the described subcortical hyperactivity.
Low frequency rTMS has shown to be associated with sustained reduction in neuronal activity.
There may be an association between the activity decreasing effect of low frequency rTMS and reduction in psychiatric symptoms.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients admitted to Århus university Hospital , Risskov or outpatients from the psychiatry district centres or practising specialist in the area.
- •Moderate - severe depression according to ICD-10/ DSM-IVR
- •Age 18-80 years
- •Total Hamilton score ( 17-items) of ≥ 18 or subscale score ≥ 9
- •Right handed
排除标准
- •Organic brain disease
- •Epilepsy in growing age
- •Metallic objects as the result of a chest or Brain surgery
- •Cardiac pacemakers
- •Somatic diseases associated with brain dysfunction
- •Pregnancy
- •Suicide risk of severe degree
- •Severe agitation or delirium
- •Alcohol and drug dependency
- •Ongoing Electroconvulsive treatment
研究组 & 干预措施
repetitive transcranial magnetic stimulation
Low frequency ( 1 HZ) rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval.
干预措施: right temporal low frequency (1 hz) rTMS (Procedure)
Placebo stimulation
Sham- rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval.
干预措施: Sham-rTMS (Procedure)
结局指标
主要结局
The total 17-item score on the Hamilton scale for depression
时间窗: 4 weeks of treatment and 4 weeks of follow-up
semistructured interview scale.
次要结局
未报告次要终点