Locating Biomarkers of Medically Intractable Obsessive Compulsive Disorder (OCD) Through the Use of Behavioral Tasks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Baylor College of Medicine
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - Beads task
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of OCD
- •Non-pregnant if female
- •Minimum score of 16 on Y-BOCS
- •Ability to provide informed consent
Exclusion Criteria
- •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
Arms & Interventions
OCD group
Day 1: Questionnaires/Assessments
Day 2: Tasks
Intervention: Beads Task (Behavioral)
OCD group
Day 1: Questionnaires/Assessments
Day 2: Tasks
Intervention: PROVOC Tasks (Behavioral)
Outcomes
Primary Outcomes
Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - Beads task
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 3
Time Frame: 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
Investigate for biomarkers of obsessive compulsive disorder pathophysiology through the use of behavioral tasks - PROVOC Task 1
Time Frame: 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 - Non-PROVOC Task 2
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Wayne Goodman MD
Principal Investigator
Baylor College of Medicine