Electroencephalography (EEG) Predictors of Repetitive Transcranial Magnetic Stimulation (rTMS) in Obsessive-Compulsive Disorder (OCD): A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- EEG biomarkers as predictors of response to rTMS
研究概览
简要总结
This study used electroencephalogram (EEG) to predict the efficacy of repetitive transcranial magnetic stimulation (rTMS) in patients with obsessive-compulsive disorder.
详细描述
Repetitive Transcranial Magnetic Stimulation (rTMS), as a relatively mature non-invasive neuromodulation technology, has been recommended for the treatment of patients with refractory OCD in multinational guidelines. However, due to the treatment setting and the patient's feature, nearly half of the patients have no significant changes after rTMS treatment.
In order to better predict the outcome of rTMS and improve the treatment efficiency, this project intends to look for markers that have a predictive effect at baseline or early treatment. Electroencephalogram (EEG) is a cheap and fast method that usually occurs before the symptoms change, thus it is possible to determine whether the patient has responded to the intervention.
In this project, the supplementary motor area (SMA) is selected as the stimulation target. The individual head magnetic resonance image positioning and navigation and rTMS compatible real-time EEG acquisition technology are used to monitor the resting state of EEG and rTMS single pulse stimulation and changes in neural networks before and after treatment. This is a preliminary exploration looking for effective predictive indicators of efficacy in EEG and the relationship between EEG and symptoms changes. In order to lay the foundation for further research and guide clinical 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 years old;
- •DSM-5 criteria for OCD;
- •Y-BOCS total score > or = 16 ->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
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)
结局指标
主要结局
EEG biomarkers as predictors of response to rTMS
时间窗: baseline
TMS-EEG and resting state EEG will be performed to investigate predictors of response to rTMS in OCD patients. The α, β and δ band power in resting state in each brain area of OCD patients will be recorded and analyzed. Also, in TMS treatment, event related potentials (ERPs) including motor evoked potentials (MEPs) amplitude, I waves, α band power and β band power will be analyzed.
Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
时间窗: Up to 6 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 The Perceived Stress Scale(PSS)(Up to 6 months)
- Change in Pittsburgh sleep quality index(PSQI)(Up to 6 months)
- Change in Side-effect questionnaire(Up to 6 months)
- Change in Obsessive Compulsive Inventory-Revised(OCI-R)(Up to 6 months)
- Change in The Beck Depression Inventory (BDI)(Up to 6 months)
- Change in The Beck Anxiety Inventory (BAI)(Up to 6 months)
研究者
Zhen Wang
Director
Shanghai Mental Health Center