Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder

NCT ID: NCT03451409

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 308 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-05
• Study Completion Date: 2024-01-24

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.

Conditions

Obsessive Compulsive Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

OCD Proband

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

Tasked based functional MRI (fMRI)

Intervention Type: 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.

Eye Tracking Device

Intervention Type: OTHER

Camera aimed at eyes to record eye movements during tasks

OCD Siblings

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

Tasked based functional MRI (fMRI)

Intervention Type: 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.

Eye Tracking Device

Intervention Type: OTHER

Camera aimed at eyes to record eye movements during tasks

Healthy Controls

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

Tasked based functional MRI (fMRI)

Intervention Type: 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.

Eye Tracking Device

Intervention Type: OTHER

Camera aimed at eyes to record eye movements during tasks

Interventions

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.

Intervention Type: OTHER

Eye Tracking Device

Camera aimed at eyes to record eye movements during tasks

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Stern, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-01606

Identifier Type: -

Identifier Source: org_study_id