Clinical trial NCT04981626: Interoception in Anorexia Nervosa
Official title: Interoception in Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anorexia
Anorexia Nervosa
Electrocardiogram
EEG
Lead sponsor: Fondation Santé des Étudiants de France
Sponsor class: OTHER
Collaborators: name: Laboratoire de Psychologie et NeuroCognition
name: University Hospital, Geneva
First posted: 2021-07-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with anorexia nervosa (group AN) and healthy control subjects (group C)

Brief 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. 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.


Eligibility criteria: Inclusion Criteria - AN groups:

* 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

Inclusion Criteria - control groups:

* 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

Exclusion Criteria for both groups:

* 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.

Primary outcomes:
measure: measure brain-stomach interactions using phase-amplitude coupling between the gastric phase and the amplitude of the cortical alpha rhythm.
timeFrame: Experimental session - 10 days maximum after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: ENS
state: Ile De France
Study officials:
affiliation: ENS
name: Marco Solca, Dr
role: PRINCIPAL_INVESTIGATOR
References: