AnorexiaINT-ANNCT04981626
Interoception in Anorexia Nervosa
An observational study of Anorexia and Anorexia Nervosa, run by Fondation Santé des Étudiants de France at 1 site in France.
Trial summary
Anorexia nervosa is a serious psychiatric illness whose causes remain poorly understood, and which remains difficult to treat to this day. Many clinical manifestations of this disease can have their origin in abnormalities in the perception of signals coming from inside the body, but this remains to be demonstrated. Read more about this study
- Who is it for?
- Ages 16 to 25 years, women only
- Conditions the study is for
- Anorexia, Anorexia Nervosa, Electrocardiogram
- What is being tested?
- Clinical and experimental session
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2022to Apr 2023
- 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 16 to 25 years
- Women only
- Child, Adult
Study population: patients with anorexia nervosa (group AN) and healthy control subjects (group C)
Who may be able to join
- Females
- 6 to 25 years old
- Diagnostic of AN according to DSM-5 criteria
- No past or current psychotic disorders
- No current substance abuse or dependence (excluding tobacco).
- No current psychiatric medication
Show all 12Show fewer
- Females
- Age : matched for the AN group
- No present or past eating disorders
- No past or current psychotic disorders
- No current substance abuse or dependence.
- No current psychiatric medication
Who cannot join
- age below 16 years and above 25 years,
- Past or current psychotic disorders,
- Current substance abuse or dependence (excluding tobacco)
- Opposition to participation has been expressed.
- In addition, for the control group,
- Subjects with present or past eating disorders or current mental disorders will be excluded.
Trial locations and contacts
1 site in 1 country.
Marco Solca, Dr contact
France1 site, 1 recruiting
- Recruiting
ENS
Paris, Île-de-France Region, 75005
Marco Solca, DR, Marco.solca@hcuge.ch
About this study
Anorexia nervosa is a serious psychiatric illness whose causes remain poorly understood, and which remains difficult to treat to this day. Many clinical manifestations of this disease can have their origin in abnormalities in the perception of signals coming from inside the body, but this remains to be demonstrated. In recent years, research in healthy subjects has shown how the brain constantly perceives the viscera (heart, lungs, stomach). The examiners will use these new, objective and validated methods to explore how the brain processes information from the viscera (interoception) in anorexic patients. In practice, they will quantify the coupling between the cardiac cycle and involuntary eye movements, as well as between the respiratory cycle and voluntary actions such as pressing a button. Finally, by simultaneously recording the electrical activity of the brain, and that of the stomach, the examiners will measure the coupling between the brain and the stomach. All these measurements, which will be compared between a population of patients and healthy subjects, will make it possible to determine whether anorexic patients have an alteration in the perception of their internal body signals and whether this damage affects several organs.
- Conditions
- Anorexia, Anorexia Nervosa, Electrocardiogram, EEG
- Being tested
- Clinical and experimental session
- Medical subject headings
- Anorexia, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and experimental sessionOther
Psychologic profile with standardized interview and scales (see below for details: SCID, BDI, STAI, BPQ, EDE Q, Pictorial Body Image Scale (PBIS) and EDI).
Measure the stomach-brain synchrony during EEG/EGG resting state, the distribution of voluntary actions across the respiratory phase, and the distribution of saccadic eye movements across the cardiac-cycle.
| Study group | Role | What they receive |
|---|---|---|
| Control | * Females
* Age : matched for the AN group
* No present or past eating disorders
* No past or current psychotic disorders
* No current substance abuse or dependence.
* No current psychiatric medication Receives: Other: Clinical and experimental session | |
| AN group | * Females
* 16 years ≤ Age ≤ 25 years
* Diagnostic of AN according to DSM-5 criteria
* No past or current psychotic disorders
* No current substance abuse or dependence (excluding tobacco).
* No current psychiatric medication Receives: Other: Clinical and experimental session |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure brain-stomach interactions using phase-amplitude coupling between the gastric phase and the amplitude of the cortical alpha rhythm.
Examiners will directly measure brain-stomach interactions using phase-amplitude coupling between the gastric phase and the amplitude of the cortical alpha rhythm.
Measured: Experimental session - 10 days maximum after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start14 Feb 2022
- Primary completionOct 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Santé des Étudiants de France
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition, University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Marco Solca, Dr, Principal investigator, ENS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981626
- Sponsor's protocol ID
- 2021-A00811-40
- Acronym
- INT-AN
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interoception in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT04981626
- Acronym / sponsor ID
- INT-AN / 2021-A00811-40
- Conditions
- Anorexia, Anorexia Nervosa, Electrocardiogram, EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondation Santé des Étudiants de FranceUniversity, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition, University Hospital, Geneva
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 29 Jul 2021 (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.
Anorexia nervosa is a serious psychiatric illness whose causes remain poorly understood, and which remains difficult to treat to this day. Many clinical manifestations of this disease can have their origin in abnormalities in the perception of signals coming from inside the body, but this remains to be demonstrated. In recent years, research in healthy subjects has shown how the brain constantly perceives the viscera (heart, lungs, stomach). The examiners will use these new, objective and validated methods to explore how the brain processes information from the viscera (interoception) in anorexic patients. In practice, they will quantify the coupling between the cardiac cycle and involuntary eye movements, as well as between the respiratory cycle and voluntary actions such as pressing a button. Finally, by simultaneously recording the electrical activity of the brain, and that of the stomach, the examiners will measure the coupling between the brain and the stomach. All these measurements, which will be compared between a population of patients and healthy subjects, will make it possible to determine whether anorexic patients have an alteration in the perception of their internal body signals and whether this damage affects several organs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Clinical and experimental session* Females * Age : matched for the AN group * No present or past eating disorders * No past or current psychotic disorders * No current substance abuse or dependence. * No current psychiatric medication |
| AN group | – | Other: Clinical and experimental session* Females * 16 years ≤ Age ≤ 25 years * Diagnostic of AN according to DSM-5 criteria * No past or current psychotic disorders * No current substance abuse or dependence (excluding tobacco). * No current psychiatric medication |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- patients with anorexia nervosa (group AN) and healthy control subjects (group C)
Key inclusion criteria (12 listed)
- Females
- 6 to 25 years old
- Diagnostic of AN according to DSM-5 criteria
- No past or current psychotic disorders
- No current substance abuse or dependence (excluding tobacco).
Key exclusion criteria (6 listed)
- age below 16 years and above 25 years,
- Past or current psychotic disorders,
- Current substance abuse or dependence (excluding tobacco)
- Opposition to participation has been expressed.
- In addition, for the control group,
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 |
|---|---|---|
| Clinical and experimental sessionPsychologic profile with standardized interview and scales (see below for details: SCID, BDI, STAI, BPQ, EDE Q, Pictorial Body Image Scale (PBIS) and EDI). Measure the stomach-brain synchrony during EEG/EGG resting state, the distribution of voluntary actions across the respiratory phase, and the distribution of saccadic eye movements across the cardiac-cycle. | Other | AN group, Control |
Primary outcome
measure brain-stomach interactions using phase-amplitude coupling between the gastric phase and the amplitude of the cortical alpha rhythm.
Time frame: Experimental session - 10 days maximum after inclusion
Examiners will directly measure brain-stomach interactions using phase-amplitude coupling between the gastric phase and the amplitude of the cortical alpha rhythm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- 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.
Marco Solca, Dr contact
Marco Solca, Dr principal investigator
ENS
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 and Anorexia Nervosa, run by Fondation Santé des Étudiants de France 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 12 inclusion and 6 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 26 Jul 2022. 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?
Contact Nathalie Godart, PU-PH (0145894339, nathalie.godart@fsef.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure brain-stomach interactions using phase-amplitude coupling between the gastric phase and the amplitude of the cortical alpha rhythm. (time frame: Experimental session - 10 days maximum after inclusion). 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 2022.