Exploring the Efficacy of Accelerated Transcranial Direct Current Stimulation (tDCS) as Adjunct to Pharmacotherapy in the Treatment of Obsessive-compulsive Disorder: A Randomized Controlled Trial Using High-resolution MRI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
研究概览
简要总结
This study will evaluate the decision-making ability and therapeutic effects of accelerated Transcranial Direct Current Stimulation (tDCS) as adjunct to pharmacotherapy in obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by EEG and MRI.
详细描述
The purpose of this study is to examine the decision-making ability and clinical efficacy of accelerated tDCS over orbitofrontal cortex (OFC) as adjunct to pharmacotherapy in treatment of OCD patients.60 OCD patients on stable medication will be randomized into two groups (i.e. active or sham stimulation). Accelerated tDCS stimulation will be performed four times a day, five times a week, for one week. Iowa Gambling Task will be conducted at the baseline, after the one week tDCS and at the 1-month follow-up to evaluate the decision-making ability of OCD patients.The investigators will assess symptom severity before and after one week of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, Clinical Global Impression(CGI), the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory-II (BDI-II), the Beck Anxiety Inventory (BAI), Childhood Trauma Questionnair(CTQ), side-effect questionnaire and other scales will be obtained by a trained investigator.The patients will also receive magnetic resonance imaging (MRI) scan, 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years old, Han ethnicity, right-handed
- •DSM-5 criteria for OCD;
- •Y-BOCS total score ≥16, receiving stable medication for at least 4 weeks before tDCS stimulation.
- •Years of education ≥9.
排除标准
- •Any axis I psychiatric disorder comorbidity
- •Severe obsessive-compulsive symptoms that render the patient unable to complete required assessment procedures.
- •Previous treatment with electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial direct current stimulation (tDCS).
- •Severe somatic diseases or any physical conditions that may induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, etc.
- •History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or traumatic brain injury/brain surgery.
- •Implantation of intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, or other internal medical devices.
- •Women who are pregnant or planning to become pregnant in the near future.
- •Serious suicide risks.
研究组 & 干预措施
active tDCS
Cathode transcranial direct current stimulation over the right OFC will be applied four times a day (2 hours interval), 5 days a week, for 1 week.
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 four times a day (2 hours interval), 5 days a week, for 1 week.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
时间窗: Up to 5 weeks
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
- The Beck Depression Inventory-II(BDI-II)(Up to 5 weeks)
- The Beck Anxiety Inventory (BAI)(Up to 5 weeks)
- Side-effect questionnaire(Up to 5 weeks)
研究者
Qing ZHAO
Attending Physician
Shanghai Mental Health Center