Community-based Transcranial Direct Current Stimulation Treatment for Bipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ]
研究概览
简要总结
Bipolar disorder is a severe and disabling disorder. The course of illness is often progressive but is highly heterogeneous between individuals and within the lifetime for an individual. The most common treatments are medications. However, for many individuals, combinations of medications are often required, and full recovery is infrequent.
The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar depression. The present research question is whether tDCS can be provided as a home-based treatment for bipolar depression for adults with bipolar disorder.
详细描述
The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar disorder. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a headband worn over the forehead with two electrodes, which are small metal discs, where the current comes from. tDCS does not directly stimulate brain cells to cause a seizure like electroconvulsive therapy (ECT) and it does not induce brain cells to discharge like transcranial magnetic stimulation (TMS).
Clinical studies have shown that tDCS treatment could help to improve the symptoms of depression. The main side effects have been redness, skin irritation or sensations (itching, tingling or burning) under the electrodes. Less commonly reported side effects include headache or tiredness. tDCS is a portable and safe treatment.
The studies to date have mostly looked at tDCS treatment which has been provided in a research setting. This is a problem because the treatment requires daily sessions for several weeks which could limit whether individuals would be able to go every day. As tDCS is a portable and safe treatment, it could be provided in the community.
The present study is a proof-of-concept trial to assess the efficacy, acceptability and safety of tDCS treatment for bipolar depression within a community-based setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of bipolar disorder based on DSM-5 criteria
- •minimum score of 18 on the MADRS
- •being on a stable dosage of mood stabilizing medication for a minimum of two weeks
排除标准
- •comorbid psychiatric disorder
- •significant risk of suicide or self harm
- •any contraindications to tDCS, including implanted electronic medical devices
- •history of epilepsy
结局指标
主要结局
Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ]
时间窗: 6 weeks
As measured by clinician-rated Montgomery Asberg Depression Rating Scale (MADRS) score improvement of 50% or more from baseline following the course of tDCS treatment.
次要结局
- Participant Retention at the End of the Treatment(6 weeks (visit 21))
- Participant Acceptability Questionnaire Scales(Week 6 (Visit 21))
研究者
Cynthia Fu
College Professor of Affective Neuroscience
University of East London