Obsessive Compulsive DisorderNCT03451409
Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder
An observational study of Obsessive Compulsive Disorder, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Tasked based functional MRI (fMRI) and Eye Tracking Device
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2018to 24 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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):
Show all 9Show fewer
- First-degree biological sibling of a person with OCD
- Additional criteria for OCD patients:
- Diagnosis of OCD according to DSM-5 criteria.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Tasked based functional MRI (fMRI), Eye Tracking Device
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Eye Tracking DeviceOther
Camera aimed at eyes to record eye movements during tasks
| Study group | Role | What they receive |
|---|---|---|
| OCD Proband | Healthy controls (HC, n=50) without a family history of OCD will be matched to SIB. Receives: 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. Receives: 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. Receives: Other: Tasked based functional MRI (fMRI); Other: Eye Tracking Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start5 May 2018
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Stern, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451409
- Sponsor's protocol ID
- 17-01606
- Status last verified
- Jul 2024
- First submitted
- 10 Jan 2018
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT03451409
- Acronym / sponsor ID
- 17-01606
- Conditions
- Obsessive Compulsive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OCD Proband | – | Other: Tasked based functional MRI (fMRI), Other: Eye Tracking DeviceHealthy controls (HC, n=50) without a family history of OCD will be matched to SIB. |
| OCD Siblings | – | Other: Tasked based functional MRI (fMRI), Other: Eye Tracking DeviceHealthy controls (HC, n=50) without a family history of OCD will be matched to SIB. |
| Healthy Controls | – | Other: Tasked based functional MRI (fMRI), Other: Eye Tracking DeviceHealthy controls (HC, n=50) without a family history of OCD will be matched to SIB. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (9 listed)
- Fluent (speaking and writing) in English
- 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
- First-degree biological sibling of a person with OCD
Key exclusion criteria (7 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Healthy Controls, OCD Proband, OCD Siblings |
| Eye Tracking DeviceCamera aimed at eyes to record eye movements during tasks | Other | Healthy Controls, OCD Proband, OCD Siblings |
Primary outcome
Brain activation in relation to sensory phenomena severity in patients with OCD
Time frame: 4 Hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Stern, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive Compulsive Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activation in relation to sensory phenomena severity in patients with OCD (time frame: 4 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.