Anorexia NervosaExplorexieNCT03799497
Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa Mental
An observational study of Anorexia Nervosa, run by University Hospital, Lille at 1 site in France.
Trial summary
Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2013to 7 Jun 2020
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Volontary subjects : patients suffering from Anorexia Nervosa and control subjects, matched by age and study level
Who may be able to join
- Providing informed, dated and signed consent (for minors, consent must be signed by both parents)
- With medical insurance
- With normal vision
- Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least one year and with a Body Masse index (BMI) between 14 and 18
- Only for the control Group : BMI between 18 and 25 and without any psychiatric disorder
Who cannot join
- Pregnant or breast-feeding women
- With antecedent or current neurologic disease
- With antecedent or current ophthalmologic disease
- Contraindication for IRMf
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa, an fMRI Activation Study
Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.
Read the detailed description
Patients suffering from Anorexia Nervosa and control subjects (matched by age and study level) are recruited in medical care facilities in Lille's Metropolis. They are asked to identify their body shape when being presented with 3 different stimuli, i.e.real (RBS), estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to identify modifications in the self body-recognition network.
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, functional MRI (fMRI), self body-shape recognition
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from Anorexia Nervosa | Subjects with a diagnostic of anorexia nervosa disorder | |
| Control group | Healthy subjects with no psychiatric disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the activation brain areas in self body-recognition network
Level of activation areas in the self body-recognition network measured during fMRI
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start7 Jun 2013
- Primary completion7 Jun 2020
- Study completion7 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Cottencin, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799497
- Sponsor's protocol ID
- 2009_48
- Other IDs
- 2010-A00545-34
- Acronym
- Explorexie
- Status last verified
- Sep 2020
- First submitted
- 3 Jan 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa, an fMRI Activation Study
- ClinicalTrials.gov ID
- NCT03799497
- Acronym / sponsor ID
- Explorexie / 2009_48
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, functional MRI (fMRI), self body-shape recognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 7 Jun 2013 (actual)
- Primary completion
- 7 Jun 2020 (actual)
- Study completion
- 7 Jun 2020 (actual)
- First posted
- 10 Jan 2019 (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.
Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.
Detailed description
Patients suffering from Anorexia Nervosa and control subjects (matched by age and study level) are recruited in medical care facilities in Lille's Metropolis. They are asked to identify their body shape when being presented with 3 different stimuli, i.e.real (RBS), estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to identify modifications in the self body-recognition network.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from Anorexia Nervosa | – | –Subjects with a diagnostic of anorexia nervosa disorder |
| Control group | – | –Healthy subjects with no psychiatric disorder |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Volontary subjects : patients suffering from Anorexia Nervosa and control subjects, matched by age and study level
Key inclusion criteria (5 listed)
- Providing informed, dated and signed consent (for minors, consent must be signed by both parents)
- With medical insurance
- With normal vision
- Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least one year and with a Body Masse index (BMI) between 14 and 18
- Only for the control Group : BMI between 18 and 25 and without any psychiatric disorder
Key exclusion criteria (4 listed)
- Pregnant or breast-feeding women
- With antecedent or current neurologic disease
- With antecedent or current ophthalmologic disease
- Contraindication for IRMf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of the activation brain areas in self body-recognition network
Time frame: 15 days
Level of activation areas in the self body-recognition network measured during fMRI
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 16 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Olivier Cottencin, MD, PhD principal investigator
University Hospital, Lille
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 Anorexia Nervosa, run by University Hospital, Lille 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 5 inclusion and 4 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 16 Sep 2020. 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?
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?
Measure of the activation brain areas in self body-recognition network (time frame: 15 days). 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 16 Sep 2020.