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CompletedNCT03451409Updated Jul 26, 2024

Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder

An observational study in Obsessive Compulsive Disorder, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-26.

Sponsored by NYU Langone Health · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
308
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obsessive Compulsive Disorder
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

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

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
308 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherTasked 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.

  • OtherEye Tracking Device

    Camera aimed at eyes to record eye movements during tasks

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What researchers measure

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.

    Time frame: 4 Hours

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Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
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Registry details

Key details

Study ID
NCT03451409
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Mar 1, 2018
Start date
May 5, 2018
Primary completion
Jan 24, 2024
Completion
Jan 24, 2024
Last update
Jul 26, 2024

Study contacts

Emily Stern, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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