Obsessive Compulsive DisorderSUPTOCNCT02850393
Inhibitory Control of the Mind : Neural Bases and Impact for Obsessive-compulsive Disorders
A study testing Functional magnetic resonance imaging, behavioral measures and physiological measurements in people with Obsessive Compulsive Disorder and Healthy, run by University Hospital, Caen at 1 site in France.
Trial summary
Mental-health conditions affect million people worldwide. The economic burden of mental illness is enormous and the economic health of both developing and developed nations will depend on controlling the staggering growth in costs from mental disorders. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder, Healthy
- What is being tested?
- Functional magnetic resonance imaging, behavioral measures and physiological measurements
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Dec 2019
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All the participants :
- Participants between 18 and 55 years old
- Affiliated to the French national health care system
- French native speaker
- Right-handed
- At least education after graduating with french GSCE "brevet des collèges"
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- Body mass < 35kg/m2
- Healthy subjects :
- Signed written consent form
- Patients :
- Patients with OCD according to DSM V diagnostic criteria at the time of the study
- Stabilized (no change of psychotropic drugs during the last 3 months)
- Signed written consent form associated with the agreement of the tutor and / or curator for protected adults
Who cannot join
- All the participants :
- Pregnancy or intent to get pregnant
- Person deprived of their liberty
- Person admitted to a health or social institution for purposes other than research
- Minor
- Protected adults or people unable to give informed consent
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- Person subjected to an exclusion period related to another protocol
- History of cancer with the last 5 years, excluding squamous cell carcinomas
- Alcoholism, antecedents of chronic alcoholism or drugs abuse
- Use of medication that may interfere with cognitive or cerebral functioning
- Presence of visual or hearing troubles that may compromise participant's ability to participate in the study
- MRI Contraindications
- Healthy subjects :
- History of neurological or psychiatric disorders or existence of traumatic brain injury with loss of consciousness for more than one hour
- Severe psychiatric disorders (according to DSM V diagnostic criteria) or psychological troubles which could affect participant's judgment
- Patients :
- Presence of neurological history, history of head trauma with loss of consciousness for more than an hour, severe depression, manic symptoms, post-traumatic stress, borderline personality disorder, antisocial, paranoid or schizoid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude en Imagerie Par résonance magnétique Fonctionnelle et Structurelle Des mécanismes de Suppression mnésique Dans Les Troubles Obsessionnels Compulsifs
Mental-health conditions affect million people worldwide. The economic burden of mental illness is enormous and the economic health of both developing and developed nations will depend on controlling the staggering growth in costs from mental disorders. Obsessive-compulsive disorder (OCD) is a relatively common and frequent form of anxiety that affects approximately 2-3% of the population. OCD is characterized by anxiety, obsessions (persistent intrusive thoughts and images with highly distressing contents) and compulsions (repetitive activity), and severely impairs the lives of those affected. Despite their interest as effective and affordable care and rehabilitation, cognitive therapeutic profits too little from the increasing accumulation of knowledge in neuroscience, and neuroscientists pay too little attention to the challenges faced by clinical psychologists and psychiatrists. To reduce this cultural gap, two teams specialized in the study and multimodal imaging of healthy participants and clinical patients with mental health disorders, the UMR-S INSERM-EPHE-UNICAEN U1077 unit led by Francis Eustache, and ISTS team (UMR-S 6301 CNRS-CEA-UCBN) led by Sonia Dollfus, will joint their efforts to develop an integrated approach of the neural mechanisms at stake from basic neuroscience using state-of-art neuroimaging techniques, to novel and ground breaking psychological intervention. Both teams evolve at the brain imaging Cyceron center in Caen in connection with the Mental Health and Addictology Center, offering unique opportunities for such translational research. This project will capitalize on recent evidence showing that healthy participants can prevent unwanted images from entering consciousness using inhibitory control and memory suppression techniques, disrupting traces of the memories in sensory areas of the brain, and weakening their vividness and later reentrance. OCD is characterized by aberrant and excessive visual intrusions, usually extremely vivid, detailed, and unpleasant. These distressing images are particularly uncontrollable and may frequently initiate compulsive rituals. In a first phase of this proposal will use functional magnetic resonance imaging (fMRI) to develop a neurobiological model of the cognitive computations achieved by inhibition network to suppress memory. To achieve this goal we will develop an attentional model of healthy memory inhibition functioning, simulating the deployment of attentional resources and the different mental processes at stake during suppression. Using sophisticated analyzing tools of fMRI data, we will use this model to decode and infer the representational content of the brain inhibition network, and further refine the connectivity pathways which underlie such control. The lack of a strong neurobiological model prevents the development of therapies which would increase functionality of this network and optimize intervention aiming to disrupt mental intrusions and obsessions. In a second phase, we will assess whether memory suppression may be transferred and trained in OCD patients using images depicting their own obsessions, as a promising avenue to reduce their symptoms on the long run. In addition, fMRI and other brain structural acquisitions will be collected before and after cognitive training to memory suppression, offering a unique opportunity to observe the online dysfunction of intrusion control in OCD patients and to identify neurobiological markers predictive of training outcome and network reconfiguration with training. A fundamental goal of motivated forgetting involves not only to exclude unwelcome content from consciousness but also to reduce their later emotional impact by doing so. In parallel of these two main phases, we will thus also measure physiological markers of autonomic nervous system activity changes in response to suppressed images to better identify the consequences of memory suppression on emotional states, anxiety, and mental health in general.
- Conditions
- Obsessive Compulsive Disorder, Healthy
- Being tested
- Functional magnetic resonance imaging, behavioral measures, physiological measurements
- Keywords
- suppression mnemonic, emotional response, inhibitory control of failures, neurological alterations
- 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.
Functional magnetic resonance imagingOther
behavioral measuresBehavioural
physiological measurementsOther
| Study group | Role | What they receive |
|---|---|---|
| patients with obsessive compulsive disorder | Experimental | Functional magnetic resonance imaging behavioral measures physiological measurements Receives: Other: Functional magnetic resonance imaging; Behavioral: behavioral measures; Other: physiological measurements |
| healthy participants | Experimental | Functional magnetic resonance imaging behavioral measures physiological measurements Receives: Other: Functional magnetic resonance imaging; Behavioral: behavioral measures; Other: physiological measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxigen Level Dependent (BOLD) response as measured with fMRI
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2019 (estimated)
- Study completionDec 2019 (estimated)
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 University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France, Université de Caen Normandie
- Responsible party
- Sponsor
- Investigators
- Anaïs Vandevelde, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850393
- Sponsor's protocol ID
- 2015-A01609-40
- Other IDs
- 160028B-31
- Acronym
- SUPTOC
- Status last verified
- Jul 2016
- First submitted
- 27 May 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude en Imagerie Par résonance magnétique Fonctionnelle et Structurelle Des mécanismes de Suppression mnésique Dans Les Troubles Obsessionnels Compulsifs
- ClinicalTrials.gov ID
- NCT02850393
- Acronym / sponsor ID
- SUPTOC / 2015-A01609-40
- Conditions
- Obsessive Compulsive Disorder, Healthy
- Keywords
- suppression mnemonic, emotional response, inhibitory control of failures, neurological alterations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France, Université de Caen Normandie
- Study start
- Jul 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Aug 2016 (estimated)
- 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.
Mental-health conditions affect million people worldwide. The economic burden of mental illness is enormous and the economic health of both developing and developed nations will depend on controlling the staggering growth in costs from mental disorders. Obsessive-compulsive disorder (OCD) is a relatively common and frequent form of anxiety that affects approximately 2-3% of the population. OCD is characterized by anxiety, obsessions (persistent intrusive thoughts and images with highly distressing contents) and compulsions (repetitive activity), and severely impairs the lives of those affected. Despite their interest as effective and affordable care and rehabilitation, cognitive therapeutic profits too little from the increasing accumulation of knowledge in neuroscience, and neuroscientists pay too little attention to the challenges faced by clinical psychologists and psychiatrists. To reduce this cultural gap, two teams specialized in the study and multimodal imaging of healthy participants and clinical patients with mental health disorders, the UMR-S INSERM-EPHE-UNICAEN U1077 unit led by Francis Eustache, and ISTS team (UMR-S 6301 CNRS-CEA-UCBN) led by Sonia Dollfus, will joint their efforts to develop an integrated approach of the neural mechanisms at stake from basic neuroscience using state-of-art neuroimaging techniques, to novel and ground breaking psychological intervention. Both teams evolve at the brain imaging Cyceron center in Caen in connection with the Mental Health and Addictology Center, offering unique opportunities for such translational research. This project will capitalize on recent evidence showing that healthy participants can prevent unwanted images from entering consciousness using inhibitory control and memory suppression techniques, disrupting traces of the memories in sensory areas of the brain, and weakening their vividness and later reentrance. OCD is characterized by aberrant and excessive visual intrusions, usually extremely vivid, detailed, and unpleasant. These distressing images are particularly uncontrollable and may frequently initiate compulsive rituals. In a first phase of this proposal will use functional magnetic resonance imaging (fMRI) to develop a neurobiological model of the cognitive computations achieved by inhibition network to suppress memory. To achieve this goal we will develop an attentional model of healthy memory inhibition functioning, simulating the deployment of attentional resources and the different mental processes at stake during suppression. Using sophisticated analyzing tools of fMRI data, we will use this model to decode and infer the representational content of the brain inhibition network, and further refine the connectivity pathways which underlie such control. The lack of a strong neurobiological model prevents the development of therapies which would increase functionality of this network and optimize intervention aiming to disrupt mental intrusions and obsessions. In a second phase, we will assess whether memory suppression may be transferred and trained in OCD patients using images depicting their own obsessions, as a promising avenue to reduce their symptoms on the long run. In addition, fMRI and other brain structural acquisitions will be collected before and after cognitive training to memory suppression, offering a unique opportunity to observe the online dysfunction of intrusion control in OCD patients and to identify neurobiological markers predictive of training outcome and network reconfiguration with training. A fundamental goal of motivated forgetting involves not only to exclude unwelcome content from consciousness but also to reduce their later emotional impact by doing so. In parallel of these two main phases, we will thus also measure physiological markers of autonomic nervous system activity changes in response to suppressed images to better identify the consequences of memory suppression on emotional states, anxiety, and mental health in general.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with obsessive compulsive disorder | Experimental | Other: Functional magnetic resonance imaging, Behavioral: behavioral measures, Other: physiological measurementsFunctional magnetic resonance imaging behavioral measures physiological measurements |
| healthy participants | Experimental | Other: Functional magnetic resonance imaging, Behavioral: behavioral measures, Other: physiological measurementsFunctional magnetic resonance imaging behavioral measures physiological measurements |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- All the participants :
- Healthy subjects :
- Patients :
Key exclusion criteria (17 listed)
- All the participants :
- Healthy subjects :
- Patients :
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 |
|---|---|---|
| Functional magnetic resonance imaging | Other | healthy participants, patients with obsessive compulsive disorder |
| behavioral measures | Behavioural | healthy participants, patients with obsessive compulsive disorder |
| physiological measurements | Other | healthy participants, patients with obsessive compulsive disorder |
Primary outcome
Blood Oxigen Level Dependent (BOLD) response as measured with fMRI
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
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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.
Anaïs Vandevelde, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging, behavioral measures and physiological measurements in people with Obsessive Compulsive Disorder and Healthy, run by University Hospital, Caen at 1 site in France.
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 13 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 1 Aug 2016. 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 France. 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?
Results are not available in the source record.
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?
Blood Oxigen Level Dependent (BOLD) response as measured with fMRI (time frame: 1 hour). 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 1 Aug 2016.