A Randomized Clinical Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Obsessive-Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
研究概览
简要总结
This study will evaluate the possible therapeutic effects of repetitive transcranial magnetic stimulation(rTMS) in obsessive-compulsive disorder (OCD) in OCD patients who have not fully responded to pharmacotherapy, and the underlying neural mechanism by EEG.
详细描述
The purpose of study is to examine the efficacy of rTMS over different brain areas, including the bilateral supplement motor Area (SMA), the right dorsal lateral prefrontal cortex (DLPFC) and SMA+DLPFC in the treatment of OCD. 120 OCD patients will be randomized into four groups. Continuous theta burst stimulation (cTBS) stimulation will be performed once a day, five times a week, for four weeks. The investigators will assess improvement after four weeks of cTBS. Though the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS), the Barratt Impulsiveness Scale-11 (BIS-11), the Beck Depression Inventory(BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale(PSS), Pittsburgh sleep quality index(PSQI), the Obsessive-Compulsive Inventory-Revised(OCI-R) and side effects will be obtained by a trained investigator. The patients will also receive magnetic resonance imaging scan and electroencephalography (EEG).
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, Investigator, Outcomes Assessor)
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
- •age>18 years old;
- •DSM-5 criteria for OCD;
- •Y-BOCS total score > or = 16, despite treatment with an adequate trial of a serotonin reuptake inhibitor (SRI) and currently using adequate, stable dose of SRI at least 4 weeks. An adequate SRI trial is defined as treatment for at least 12 weeks on the SRI, that meets or exceeds the recommended dosage level for OCD;
- •>or＝9 yrs education
排除标准
- •any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder
- •serious suicide risk;
- •the inability to receive rTMS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery;
- •any major medical disease;
- •pregnancy or nursing of an infant;
- •participation in current clinical study;
- •current use of any investigational drug;
- •TMS/DBS treatment at any point in their lifetime;
- •history of long-time use of benzodiazepines
研究组 & 干预措施
Group1: rTMS(bilateral SMA)
Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.
干预措施: Continuous theta burst stimulation (cTBS) (Device)
Group2: rTMS(right DLPFC)
Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC once a day, 5 days/week, for 4 weeks.
干预措施: Continuous theta burst stimulation (cTBS) (Device)
Group3: rTMS(right DLPFC+bilateral SMA)
Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC and bilateral SMA once a day, 5 days/week, for 4 weeks.
干预措施: Continuous theta burst stimulation (cTBS) (Device)
Group4: shame rTMS
The sham rTMS will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.
干预措施: shame rTMS (Device)
结局指标
主要结局
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
时间窗: Up to 6 months
The responder on Y-BOCS is defined as a Y-BOCS decrease at least 25% from the baseline at post-treatment
次要结局
- Perceived Stress Scale(PSS)(Up to 6 months)
- The Barratt Impulsiveness Scale-11 (BIS-11)(Up to 6 months)
- The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)(Up to 6 months)
- The Beck Anxiety Inventory (BAI)(Up to 6 months)
- The Beck Depression Inventory(BDI)(Up to 6 months)
- side effects(Up to 6 months)
- State-trait Anxiety Inventory(STAI)(Up to 6 months)
- Pittsburgh sleep quality index(PSQI)(Up to 6 months)
- The Obsessive-Compulsive Inventory-Revised(OCI-R)(Up to 6 months)
研究者
Zhen Wang
vice-president
Shanghai Mental Health Center