Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder

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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Other: Tasked based functional MRI (fMRI); Other: Eye Tracking Device

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.

• Study Type: Interventional
• Enrollment (Actual): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolette Recchia; Phone Number: 845-398-5590; Email: nicolette.recchia@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OCD Proband; Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.	Other: Tasked based functional MRI (fMRI); 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.; Other: Eye Tracking Device; Camera aimed at eyes to record eye movements during tasks
Active Comparator: OCD Siblings; Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.	Other: Tasked based functional MRI (fMRI); 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.; Other: Eye Tracking Device; Camera aimed at eyes to record eye movements during tasks
Active Comparator: Healthy Controls; Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.	Other: Tasked based functional MRI (fMRI); 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.; Other: Eye Tracking Device; Camera aimed at eyes to record eye movements during tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 Hours

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Emily Stern, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2018
• Primary Completion (Actual): January 24, 2024
• Study Completion (Actual): January 24, 2024

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 17-01606

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No