NCT04981626

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

February 14, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

July 20, 2021

Last Update Submit

July 22, 2022

Conditions

AnorexiaAnorexia NervosaElectrocardiogramEEG

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

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.

AN groupControl

Eligibility Criteria

Age16 Years - 25 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Females
  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENS

Paris, Île-de-France Region, 75005, France

RECRUITING

MeSH Terms

Conditions

AnorexiaAnorexia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding and Eating DisordersMental Disorders

Study Officials

  • Marco Solca, Dr

    ENS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Godart, PU-PH

CONTACT

0145894339nathalie.godart@fsef.net

Marco Solca, Dr

CONTACT

marco.solca@hcuge.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 29, 2021

Study Start

February 14, 2022

Primary Completion

October 1, 2022

Study Completion

April 1, 2023

Last Updated

July 26, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)