Locating Biomarkers of Medically Intractable Obsessive Compulsive Disorder (OCD) Through the Use of Behavioral Tasks
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - PROVOC Task 1
研究概览
简要总结
Subjects that have a diagnosis of OCD will participate in a clinical interview and cognitive tasks, during which they will be exposed to their individual OC stressors or will be asked to make decisions related to information value and quantity while measuring neural activity and filming facial reactions. This will assist investigators to look for biomarkers of that change. This study offers a unique opportunity to develop biomarkers for key domains of OCD, and other neuropsychiatric disorders, that are grounded in brain neurocircuitry at the individual-patient level.
Subjects will participate in a clinical interview (Day 1), and then tasks+EEG (Day 2). Day 1 will be 4 hours or less, and Day 2 will be 2.5 hours or less.
详细描述
This is a research study in which BCM is collaborating with Brown University/Butler Hospital and University of Pittsburgh. BCM and Butler Hospital will be enrolling sites. Brown University and University of Pittsburgh will be analyzing the assessment, EEG and facial recognition data.
Subjects will participate in a clinical interview (Day 1), and cognitive tasks with EEG (Day 2).
Neural data (through EEG) will be collected from OCD subjects when their symptoms are provoked, so we can look for biomarkers of that change. The subjects will be monitored through EEG and video recording for facial recognition. After initial video and EEG setup subjects will complete the Beads task followed by the Provocation task.
Day 1:
Demographics Questionnaire. Assesses psychiatric and medical treatment history.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OCD
- •Non-pregnant if female
- •Minimum score of 16 on Y-BOCS
- •Ability to provide informed consent
排除标准
- •Those not meeting inclusion criteria listed above
- •Lifetime diagnosis of psychotic disorders such as schizophrenia
- •Alcohol or substance abuse/dependence within 6 months, excluding nicotine
- •Deemed at high risk of suicidal behavior or impulsivity
- •Pregnant or plans to become pregnant in the next 24 months
结局指标
主要结局
Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - PROVOC Task 1
时间窗: Day 2
Subject will undergo PROVOC Task 1 with Item 1 of 3 that may invoke OCD triggers while EEG and videotape monitors neural and facial data throughout
Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - Beads task
时间窗: Day 2
Subject will perform beads task while EEG and videotape monitors neural and facial data throughout
Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - PROVOC Task 2
时间窗: Day 2
Subject will undergo PROVOC Task 2 with Item 2 of 3 that may invoke OCD triggers while EEG and videotape monitors neural and facial data throughout
Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - PROVOC Task 3
时间窗: Day 2
Subject will undergo PROVOC Task 3 with Item 3 of 3 that may invoke OCD triggers while EEG and videotape monitors neural and facial data throughout
Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - Non-PROVOC Task 1
时间窗: Day 2
Subject will undergo the same exposure task with Item 1 of 3 that does not invoke OCD triggers while EEG and videotape monitors neural and facial data throughout
Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - Non-PROVOC Task 2
时间窗: Day 2
Subject will undergo the same exposure task with Item 2 of 3 that does not invoke OCD triggers while EEG and videotape monitors neural and facial data throughout
Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - Non-PROVOC Task 3
时间窗: Day 2
Subject will undergo the same exposure task with Item 3 of 3 that does not invoke OCD triggers while EEG and videotape monitors neural and facial data throughout
次要结局
未报告次要终点
研究者
Wayne Goodman MD
Principal Investigator
Baylor College of Medicine