Electroencephalography (EEG) Predictors of Response to Transcranial Direct Current Stimulation (tDCS) Treating Obsessive-Compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in long-interval intracortical inhibition (LICI) and short interval intracortical inhibition (SICI) measured by TMS-EEG
研究概览
简要总结
This study is designed to find Electroencephalogram (EEG) biomarkers to predict transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder.
详细描述
The purpose of this study is to explore resting state electroencephalography and transcranial magnetic stimulation and electroencephalography (TMS-EEG) biomarkers that would predict transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder with cathode electrode targeting orbitofrontal cortex (OFC). 30 OCD patients will be recruited to this study and performed once a day, five times a week direct current stimulation treatment 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), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. Resting state electroencephalography and TMS-EEG testing will be conducted before and after tDCS treatment.
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 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
- •>or＝9 years education
排除标准
- •any additional current psychiatric comorbidity
- •The inability to receive tDCS because of metallic implants, or history of seizures，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
tDCS treatment
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)
结局指标
主要结局
Change in long-interval intracortical inhibition (LICI) and short interval intracortical inhibition (SICI) measured by TMS-EEG
时间窗: Up to 2 weeks
LICI and SICI are TMS-EEG paradigm to assess the extent of cortical inhibition. LICI and SICI will be measured using single and paired TMS pulses applied to the OFC. LICI and SICI will be compared between before and after treatment.
Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
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.
EEG biomarkers as predictors of response to tDCS
时间窗: baseline
LICI and SICI measured by TMS-EEG and resting state EEG will be performed to investigate predictors of response to tDCS in OCD patients.
次要结局
- Change in The Beck Depression Inventory(BDI)(Up to 3 months)
- Change in Pittsburgh sleep quality index(PSQI)(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 The Beck Anxiety Inventory (BAI)(Up to 3 months)
研究者
Zhen Wang
vice-president
Shanghai Mental Health Center