A Study of Function-metabolism Coupling in Decision-making Confidence Neural Network of Obsessive-compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Yale-Brown Obsessive-Compulsive Scale (YBOCS)
研究概览
简要总结
This study, a case-control study, aims to investigate the function-metabolism coupling in decision-making confidence neural network of obsessive-compulsive disorder.
详细描述
OCD shows various abnormalities in cognitive function. Decision-making confidence is a burgeoning research focus on cognitive abnormality of OCD. Gamma-aminobutyric acid (GABA) is a type of inhibitory amino acid. Some studies have indicated that GABA shows metabolic abnormality in OCD.
Repetitive transcranial magnetic stimulation (rTMS) is a safe and noninvasive treatment for OCD. This study intends to explore the differences of the function-metabolism coupling in decision-making confidence neural network between OCD and HC. And investigating the dynamic changes of the function-metabolism coupling after rTMS treatment (6 weeks) for OCD is another goal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Age between 18 and 50 years.
- •Satisfied with the diagnostic criteria for OCD in DSM-V.
- •Taking medication or unmedication stably for 8 weeks or drug-naive.
- •YBOCS score ≥
- •Education level was limited to above middle school.
- •Has sufficient audiovisual skills to complete the necessary examinations for the study.
- •Right-handed (this criterion is for fMRI subjects only).
- •Subjects understood the study and signed informed consent.
- •Match with the OCD group on age, gender, education years.
- •Unsatisfied with the diagnostic criteria for any mental disorder in DSM-V.
- •No history of taking psychotropic drugs.
- •No family genetic history of mental disorder.
- •Has sufficient audiovisual skills to complete the necessary examinations for the study.
- •Right-handed (this criterion is for fMRI subjects only).
- •Subjects understood the study and signed informed consent.
排除标准
- •Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
- •HAMD-17 score ≥
- •Obsessive-compulsive symptoms were too severe to participate in the experiment.
- •Hoarding symptom.
- •High risk of negative thought and suicide.
- •Severe central system or physical disease or drug abuse.
- •Pregnant women or women that getting ready for being pregnant and lactating.
- •With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)
- •High risk of negative thought and suicide.
- •HAMD-17 score ≥
- •Severe central system or physical disease or drug abuse.
- •Pregnant women or women that getting ready for being pregnant and lactating.
- •With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)
研究组 & 干预措施
OCD group
OCD patients will receive rTMS treatment for 6 weeks.
干预措施: Repetitive transcranial magnetic stimulation (Device)
HC group
Health control will not receive any treatment.
结局指标
主要结局
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
时间窗: Change from Baseline at 6weeks
YBOCS is compiled by Goodman in the United States and contains 10 items to assess the severity of obsessive thoughts and compulsive behavior. The scoring method adopts a five-point scale of 0-4 points, and the total score range is 0-40 points, which has good reliability and validity.
次要结局
- Hamilton Depression Scale (HAMD-17)(Change from Baseline at 6weeks)
- Hamilton Anxiety Scale (HAMA-14)(Change from Baseline at 6weeks)
- State-Trait Anxiety Inventory (STAI)(Change from Baseline at 6weeks)
- Florida Obsessive Compulsive Inventory (FOCI)(Change from Baseline at 6weeks)
- Obsessive Belief Questionnaire (OBQ-44)(Change from Baseline at 6weeks)