Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The change over time in the score of Hamilton Depression Rating Scale (HDRS-17).
研究概览
简要总结
The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. We hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.
详细描述
This is a randomized, double-blind, sham-controlled study to detect the effect of dTMS for treatment of bipolar depression. 100 participants were randomly assigned 1:1 to dTMS group or sham-control group. For both active and sham group, daily dTMS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Based on the original and stable medication, the active stimulation consisted of 55 18 Hz, 2 s trains at 120% motor threshold (MT) intensity, with a between-train interval of 20 s (1980 pulses per day or 39 600 pulses per treatment). The sham stimulation was performed using the same procedures, with the sham coil.
Scale assessments are performed at baseline, week 2, week 4 and week 8. Collection of blood took place at baseline, week 4 and week 8.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of bipolar depression;
- •age between 18 and 65 years;
- •a 17-item Hamilton Depression Rating Scale (HDRS-17) score >= 17,
- •a stable pharmacological regimen maintained for at least 4 weeks prior to the beginning of the treatment phase ;
- •for participants who had previously received antidepressant therapy, a minimum 4-week washout period followed by re-evaluation.
排除标准
- •a lifetime history of other psychiatric disorders, neurological diseases, or severe brain injury;
- •receipt of electroconvulsive therapy, rTMS, transcranial direct current stimulation, transcranial alternating current stimulation, or other neurostimulation treatments within the previous 3 months;
- •contraindications to magnetic stimulation, including epilepsy, cardiovascular disorders, or metallic implants in the head;
- •the presence of hypomanic/manic symptoms at baseline or a score greater than 12 on the Young Mania Rating Scale (YMRS);
- •pregnancy or lactation.
研究组 & 干预措施
dTMS group
Participants receive active stimulation with H1 coil, consisting of 55 18 Hz, 2 s trains at 120% MT intensity, with a between-train interval of 20 s ,1980 pulses per day. The subjects were stimulated every day for 4 weeks (except weekends).
干预措施: deep Transcranial Magnetic Stimulation (dTMS) -active (Device)
sham group
The sham stimulation was performed using the same procedures, with the sham coil.
干预措施: deep Transcranial Magnetic Stimulation (dTMS) -sham (Device)
结局指标
主要结局
The change over time in the score of Hamilton Depression Rating Scale (HDRS-17).
时间窗: baseline, week 2, week 4, week 8
The aim is to explore whether deep Transcranial Magnetic Stimulation (dTMS) combined with Pharmacological treatment could alleviate the severity of depressive symptoms as measured with HDRS-17 in bipolar depression after 4-week treatment. Hamilton Depression Rating Scale (HDRS-17) was used to evaluate the severity of symptoms of depression. Higher total score of the scale means more severe depressive symptoms.
次要结局
- The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)(baseline, week 2, week 4, week 8)
- The change of scores in MATRICS Consensus Cognitive Battery(MCCB)(baseline, week 4, week 8)
- Response and remission rates at weeks 2, week 4 and week 8 with HDRS-17.(weeks 2, week 4 and week 8)
- The changes of levels of Brain Derived Neurotrophic Factor (BDNF) in peripheral blood(baseline, week 4, week 8)
- The change of scores of adverse events scale from baseline to week 4(baseline, week 4)