Back to resultsNeurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder
Primary Purpose
Obsessive Compulsive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tasked based functional MRI (fMRI)
Eye Tracking Device
Sponsored by
About this trial
This is an interventional basic science trial for Obsessive Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- Fluent (speaking and writing) in English
Additional criteria for healthy controls (HC):
- Lifetime absence of major Axis I diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
- Not taking psychotropic medications
- No first-degree biological relatives with OCD
Additional criteria for siblings (SIB):
- First-degree biological sibling of a person with OCD
Additional criteria for OCD patients:
- Diagnosis of OCD according to DSM-5 criteria.
Exclusion Criteria:
- Current moderate or high suicidality as assessed through the Mini International Neuropsychiatric Interview (MINI) 7.0.2 suicidality module
- MRI contraindications such as claustrophobia, ferrous implants, braces, or pacemakers
- Major neurological illness (e.g., self-reported history of organic mental syndromes, head trauma, migraines, seizures, other Central Nervous System (CNS) disease, or other significant medical illness that would make participation unsafe or unfeasible)
- Positive urine toxicology or pregnancy test
- Any disability or health problem that prevents them from completing study procedures (e.g. back problems, severe carpal tunnel syndrome, impaired vision that is not corrected with glasses or contact lenses, etc.).
- Present diagnosis of alcohol use disorder or substance use disorder (moderate or severe)
- Present or previous diagnosis of psychosis, bipolar disorder, or major developmental disorder (autism spectrum disorder, intellectual developmental disorder) based on DSM-5 criteria.
Sites / Locations
- New York University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
OCD Proband
OCD Siblings
Healthy Controls
Arm Description
Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.
Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.
Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.
Outcomes
Primary Outcome Measures
Brain activation in relation to sensory phenomena severity in patients with OCD
Statistical modeling using path analysis will test whether brain activation, functional connectivity, and diffusion measures predict Sensory Phenomena (SP) better than alternative models of predictive influence.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03451409
Brief Title
Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder
Official Title
Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2018 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Research Domain Criteria (RDoC) approach seeks to address the neurobiological mechanisms of sensory symptoms in patients with obsessive-compulsive disorder (OCD) by investigating dimensional components of behavior that more closely align with brain circuitry. This project focuses on the dimensional symptom of sensory phenomena (SP), which are uncomfortable or aversive sensory experiences that drive repetitive behaviors in OCD, including "not just right" sensations, physical urges, and sensations of disgust. SP are very prevalent, occurring in 60-80% of OCD patients, and experienced as highly distressing. Unfortunately, SP are not well addressed by standard treatment approaches, which may be in part because their neurobiological mechanisms are not well understood.
This project builds on our preliminary data to (1) investigate the neural mechanisms of SP in large OCD cohort showing the full range of SP severity and (2) probe for familial risk markers in unaffected siblings of patients. For Aim 1, SP will be measured in 100 OCD patients using the Sensory Phenomena Scale. Diffusion and fMRI data will be acquired during rest and fMRI tasks. In order to identify familial risk markers, Aim 2 will compare sensory phenomena and neural circuitry between OCD probands, 50 unaffected biological siblings of OCD patients, and 50 unrelated healthy controls without a family history of Axis 1 disorders.
Detailed Description
This project investigates the neurobiological mechanisms of sensory symptoms in patients with obsessive-compulsive disorder (OCD) and their siblings using task-based fMRI, resting-state functional connectivity, and diffusion MRI approaches. OCD is a chronic disorder presenting a high public health burden. Treatment presents a particular challenge because OCD is extremely heterogeneous, with clusters of symptoms likely derived from differing neural etiologies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OCD Proband
Arm Type
Active Comparator
Arm Description
Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.
Arm Title
OCD Siblings
Arm Type
Active Comparator
Arm Description
Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.
Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.
Intervention Type
Other
Intervention Name(s)
Tasked based functional MRI (fMRI)
Intervention Description
2-3 brief computer tasks while brain activity is being measured. The tasks performed will involve making button press responses to letters, numbers or shapes on the computer screen.
Intervention Type
Other
Intervention Name(s)
Eye Tracking Device
Intervention Description
Camera aimed at eyes to record eye movements during tasks
Primary Outcome Measure Information:
Title
Brain activation in relation to sensory phenomena severity in patients with OCD
Description
Statistical modeling using path analysis will test whether brain activation, functional connectivity, and diffusion measures predict Sensory Phenomena (SP) better than alternative models of predictive influence.
Time Frame
4 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fluent (speaking and writing) in English
Additional criteria for healthy controls (HC):
Lifetime absence of major Axis I diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
Not taking psychotropic medications
No first-degree biological relatives with OCD
Additional criteria for siblings (SIB):
First-degree biological sibling of a person with OCD
Additional criteria for OCD patients:
Diagnosis of OCD according to DSM-5 criteria.
Exclusion Criteria:
Current moderate or high suicidality as assessed through the Mini International Neuropsychiatric Interview (MINI) 7.0.2 suicidality module
MRI contraindications such as claustrophobia, ferrous implants, braces, or pacemakers
Major neurological illness (e.g., self-reported history of organic mental syndromes, head trauma, migraines, seizures, other Central Nervous System (CNS) disease, or other significant medical illness that would make participation unsafe or unfeasible)
Positive urine toxicology or pregnancy test
Any disability or health problem that prevents them from completing study procedures (e.g. back problems, severe carpal tunnel syndrome, impaired vision that is not corrected with glasses or contact lenses, etc.).
Present diagnosis of alcohol use disorder or substance use disorder (moderate or severe)
Present or previous diagnosis of psychosis, bipolar disorder, or major developmental disorder (autism spectrum disorder, intellectual developmental disorder) based on DSM-5 criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pearl Kravets
Phone
845-398-6563
Email
pearl.kravets@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Stern, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carina Brown
Phone
212-404-3919
First Name & Middle Initial & Last Name & Degree
Emily R Stern, MD
12. IPD Sharing Statement
Learn more about this trial
Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder
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