Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

Official title:

Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451409
• Other study ID #: 17-01606
• Status: Completed
• Phase: N/A
• Start date: May 5, 2018
• Est. completion date: January 24, 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: January 24, 2024
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

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.
• Eye Tracking Device
Camera aimed at eyes to record eye movements during tasks

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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