INT-AN: Interoception in Anorexia Nervosa

Sponsor
Fondation Santé des Étudiants de France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04981626
Collaborator
Laboratoire de Psychologie et NeuroCognition (Other), University Hospital, Geneva (Other)
50
1
13.5
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical and experimental session

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Interoception in Anorexia Nervosa
Actual Study Start Date :
Feb 14, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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]

    Examiners will directly measure brain-stomach interactions using phase-amplitude coupling between the gastric phase and the amplitude of the cortical alpha rhythm.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 25 Years
Sexes Eligible for Study:
Female
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ENS Paris Ile De France France 75005

Sponsors and Collaborators

  • Fondation Santé des Étudiants de France
  • Laboratoire de Psychologie et NeuroCognition
  • University Hospital, Geneva

Investigators

  • Principal Investigator: Marco Solca, Dr, ENS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Santé des Étudiants de France
ClinicalTrials.gov Identifier:
NCT04981626
Other Study ID Numbers:
  • 2021-A00811-40
First Posted:
Jul 29, 2021
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2022