Interoception in Anorexia Nervosa (INT-AN)

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 Overview

• Status: Recruiting
• Conditions: Anorexia Nervosa; Anorexia; EEG; Electrocardiogram
• Intervention / Treatment: Other: Clinical and experimental session

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Nathalie Godart, PU-PH; Phone Number: 0145894339; Email: nathalie.godart@fsef.net
• Study Contact Backup: Name: Marco Solca, DR; Email: Marco.solca@hcuge.ch

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75005
      • Recruiting
      • ENS
      • Contact: Marco Solca, DR; Email: Marco.solca@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

patients with anorexia nervosa (group AN) and healthy control subjects (group C)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Clinical and experimental session; 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.
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	Other: Clinical and experimental session; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Experimental session - 10 days maximum after inclusion

Collaborators and Investigators

• Sponsor: Fondation Santé des Étudiants de France
• Collaborators: University Hospital, Geneva; Laboratoire de Psychologie et NeuroCognition
• Investigators: Principal Investigator: Marco Solca, Dr, ENS

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 2021-A00811-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No