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Locating Biomarkers in OCD Through Behavioral Tasks

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ClinicalTrials.gov Identifier: NCT03313622
Recruitment Status : Not yet recruiting
First Posted : October 18, 2017
Last Update Posted : January 15, 2019
Sponsor:
Collaborators:
Brown University
University of Pittsburgh
Butler Hospital
Information provided by (Responsible Party):
Wayne Goodman MD, Baylor College of Medicine

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.


Condition or disease Intervention/treatment
OCD Obsessive-Compulsive Disorder Behavioral: Beads Task Behavioral: PROVOC Tasks

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Locating Biomarkers of Medically Intractable Obsessive Compulsive Disorder (OCD) Through the Use of Behavioral Tasks
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
OCD group

Day 1: Questionnaires/Assessments

Day 2: Tasks

Behavioral: Beads Task
Participants will be asked to make a series of decisions that involve combining information about the value and probability of potential rewards. Subjects will sit in front of a computer monitor and place their hand over a box with orange and blue button that they will be asked to press based on their idea of which one will be the majority in a jar full of orange and blue beads. This task should take 15-20 minutes to complete, not including EEG setup.

Behavioral: PROVOC Tasks
Three tasks will be developed collaboratively with the participant and independent evaluator that involve the participant being exposed to triggers that are considered by him/her impossible to confront without ritualizing. There will also be a similar process involving objects that should not cause any distress to be used as a control. Sessions will be videotaped with AFAR system concurrent to recording of LFPs from VS and scalp EEG.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential subjects are patients diagnosed with OCD meeting the inclusion/exclusion criteria above.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313622


Contacts
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Contact: Clarissa Aguilar 713-798-3080 Clarissa.Aguilar@bcm.edu
Contact: Gregory Vogt 713-798-4729 gsvogt@bcm.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15260
United States, Rhode Island
Brown University Active, not recruiting
Providence, Rhode Island, United States, 02912
United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Clarissa Aguilar    713-798-3080    Clarissa.Aguilar@bcm.edu   
Contact: Gregory Vogt    (713) 798-4729    gsvogt@bcm.edu   
Principal Investigator: Wayne K Goodman, MD         
Sub-Investigator: Raymond Cho, MD, PhD         
Sub-Investigator: Nithya Ramakrishnan, MS         
Sub-Investigator: Eric Storch, PhD         
Sub-Investigator: Elizabeth McIngvale, PhD         
Sub-Investigator: Gregory Vogt         
Sponsors and Collaborators
Baylor College of Medicine
Brown University
University of Pittsburgh
Butler Hospital
Investigators
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Principal Investigator: Wayne Goodman, MD Baylor College of Medicine

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Responsible Party: Wayne Goodman MD, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03313622     History of Changes
Other Study ID Numbers: H42237
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wayne Goodman MD, Baylor College of Medicine:
OCD
Obsessive Compulsive Disorder
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders