Interoception in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— INT-AN  

Official title:

Interoception in Anorexia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981626
• Other study ID #: 2021-A00811-40
• Status: Recruiting
• Start date: February 14, 2022
• Est. completion date: April 2023

Study information

• Verified date: July 2021
• Source: Fondation Santé des Étudiants de France
• Contact: Nathalie Godart, PU-PH
• Phone: 0145894339
• Email: nathalie.godart[@]fsef.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2023
• Est. primary completion date: October 2022
• Gender: Female
• Age group: 16 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• EEG
• Electrocardiogram

Intervention

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.

Locations

Country	Name	City	State
France	ENS	Paris	Ile De France

Sponsors (3)

Lead Sponsor	Collaborator
Fondation Santé des Étudiants de France	Laboratoire de Psychologie et NeuroCognition, University Hospital, Geneva

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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