跳至主要内容
临床试验/NCT02966106
NCT02966106撤回不适用

The Antidepressive Effect of Low Frequency Right Prefrontal Repetitive Transcranial Magnetic Stimulation as add-on to Antidepressant Drug Treatment. A Blinded, Placebo Controlled Randomised Study.

University of Aarhus0 个研究点开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
remission

研究概览

简要总结

rTMS has appeared a potential new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the brain through a time varying magnetic field. ). Research on rTMS reports of minimal side effects of the method . The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex .

Fewer studies have used right prefrontal, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation .Both stimulus models has been shown to have statistically significant antidepressant effect and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex i associated with an antidepressant effect at the same level as the high frequency model. Therefore the investigators want to examine the antidepressant effect of a specific rTMS low frequency model in a clinical setting using a placebo controlled, randomized double blind design.

详细描述

rTMS has appeared a potential new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the brain through a time varying magnetic field. ). RTMS is based on the principle of electromagnetism. An electromagnetic coil placed on the scalp produces a time-varying magnetic field that penetrates the scalp and skull unattenuated and gives rise to a current in the proximity of the cerebral cortex as well as functionally connected parts of the brain. Research on rTMS reports of minimal side effects of the method Previous research indicates that the antidepressant effect of rTMS is associated with specific stimulation of the dorsolateral prefrontal cortex. The stimulus frequency has shown to play a key role in the mechanisms of action of rTMS. Previous animal studies have shown that low frequency rTMS is associated with long term inhibition of neuronal activity (long term depression), while high frequency stimulation is followed by prolonged activation (long term potentiation). To some extent, this differential effect of different frequencies is reflected in human studies (REF).

The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex , which has been approved by the USA FDA (1) and later in EU for the treatment of depression.

Fewer studies have used right prefrontal, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation . In addition low frequency rTMS is generally less time-consuming. Both stimulus models has been shown to have a modest, statistically significant antidepressant effect and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex i associated with an antidepressant effect at the same level as the high frequency model. The issue indicates that low frequency due to the more advantagous side effect profile should be the stimulus model of choice in a clinical setting.

Therefore the investigators want to examine the antidepressant effect of a specific rTMS low frequency model in a clinical setting using a placebo controlled, randomized double blind design.

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
Triple (Participant, Care Provider, Investigator)

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

入选标准

  • Out-patients referred to Aarhus University Hospital, Risskov
  • Moderate-severe uni- and bipolar depression according to ICD-10
  • Age 18-80 years

排除标准

  • Organic brain disease.
  • Epileptic seizure < 2 years
  • Patients with implanted metal parts in the brain or chest
  • Patients with pacemaker
  • Medical diseases with cerebral impact
  • Serious suicidal danger

研究组 & 干预措施

Sham-rTMS

Placebo Comparator

Right prefrontal rTMS sham treatment. A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval

干预措施: Sham-rTMS (Other)

Right prefrontal low frequency rTMS.

Active Comparator

Right prefrontal low frequency rTMS (1Hz). A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval

干预措施: Right prefrontal low frequency rTMS (Device)

结局指标

主要结局

remission

时间窗: 8 weeks

the number of patients obtaining a Hamilton-17 item total score of \< 8

次要结局

  • Response(8 weeks)
  • Cognitive function(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

相似试验