Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder

NCT03451409 | Completed

• 1 other identifier: 17-01606
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

OCD Proband

Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.

Other: Tasked based functional MRI (fMRI); Other: Eye Tracking Device

OCD Siblings

Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.

Other: Tasked based functional MRI (fMRI); Other: Eye Tracking Device

Healthy Controls

Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB.

Other: Tasked based functional MRI (fMRI); Other: Eye Tracking Device

Interventions

Tasked based functional MRI (fMRI) OTHER

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.

Healthy Controls; OCD Proband; OCD Siblings

Eye Tracking Device OTHER

Camera aimed at eyes to record eye movements during tasks

Healthy Controls; OCD Proband; OCD Siblings

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will involve 18-60 year-old male or female volunteer subjects of any racial or ethnic group. This will include 100 OCD patients, 50 unaffected biological siblings (SIB) and 50 healthy controls (HC).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Emily Stern, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: March 1, 2018
• Study Start: May 5, 2018
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

US (1)