A Randomized Clinical Trial of Transcranial Direct Current Stimulation(tDCS) Treatment for Drug-naïve Obsessive-Compulsive Disorder(OCD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
研究概览
简要总结
This study will evaluate the possible therapeutic effects of Transcranial Direct Current Stimulation (tDCS) in drug-naïve obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by magnetic resonance imaging (MRI),transcranial magnetic stimulation and electroencephalography (TMS-EEG).
详细描述
The purpose of this study is to examine the efficacy of tDCS over orbitofrontal cortex (OFC) in treatment of drug-naïve OCD patients. 60 drug-naïve OCD patients will be randomized into two groups (i.e. active or sham stimulation). tDCS stimulation will be performed once a day, five times a week, for two weeks. The investigators will assess symptom severity before and after two weeks of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale (PSS), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. The patients will also receive MRI scan and TMS-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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18-50 years old;
- •DSM-5 criteria for OCD;
- •Y-BOCS total score > or = 16, discontinued medication for at least 8 weeks before tDCS stimulation.
- •>or＝9 years education
排除标准
- •Any axis I psychiatric disorder comorbidity
- •The inability to receive tDCS because of metallic implants, or history of seizures，or 3.history of head injury, or history of neurosurgery.
- •Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
- •Any current significant medical condition.
- •serious suicide risk
研究组 & 干预措施
active tDCS
Cathode transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.
干预措施: high-definition transcranial direct current stimulation (Device)
sham tDCS
The sham transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
时间窗: Up to 3 months
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.
次要结局
- Change in Perceived Stress Scale(PSS)(Up to 3 months)
- Change in Side-effect questionnaire(Up to 3 months)
- Change in Obsessive Compulsive Inventory-Revised(OCI-R)(Up to 3 months)
- Change in Beck Depression Inventory(BDI)(Up to 3 months)
- Change in Pittsburgh sleep quality index(PSQI)(Up to 3 months)
- Change in Beck Anxiety Inventory (BAI)(Up to 3 months)
研究者
Zhen Wang
vice-president
Shanghai Mental Health Center