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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03850288
Other study ID # 69HCL18_0621
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2019
Est. completion date February 26, 2020

Study information

Verified date January 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Executive functions are part of the high-level cognitive processes essential to the proper functioning of human cognition. They consist mainly of flexibility, updating and inhibition. Some studies have shown a correlation between executive disorders (impaired executive function) and psychiatric disorders such as obsessive-compulsive disorder or phobias. These executive disorders are related to dysfunctions of the fronto-striatal loops. In addition, other studies have investigated the link that may exist between eating disorders such as anorexia or bulimia nervosa and executive functioning. Anorexia nervosa, bulimia nervosa and binge eating disorders are eating disorders characterized by a dysfunction in food intake with restriction of food or compulsions as well as strong concerns about the body schema. Concerning the executive functioning, these studies highlight a lack of cognitive flexibility for patients with anorexia nervosa and bulimia nervosa but also dysfunctions depending on the type of pathology (anorexia nervosa or bulimia nervosa). These studies also highlight the beneficial effects of cognitive remediation on people with eating disorders. However, the investigation of the inhibitory control has not yet been specifically studied. Moreover, since eating disorders are structurally different, a comparison between several pathologies would be interesting to consider. The aim of this study is to determine if a dysfunction of inhibitory control can be highlighted in people with eating disorders. This study would also allow further researches about cognitive remediation suitable for the specific difficulties encountered in these diseases.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date February 26, 2020
Est. primary completion date February 26, 2020
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria: - Woman aged 19 to 40 years old - Patient with a BMI between 13 and 40 kg/m2 - Outpatients of the Refering Center of Eating Disorders ('Hospices Civils de Lyon' in Lyon) suffering of an eating disorder diagnosis (Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder) - Patient who agrees to participate to the study. Exclusion Criteria: - Patient with psychiatric comorbidity severe (DSM V) and not stable (during the 8 weeks before inclusion) - Patient with psychotropic treatment (started or modified during the 8 weeks before inclusion) - Major patient protected by a measure of legal protection - Patient younger than 19 years old - Participation to another study at the same time

Study Design


Intervention

Other:
Neuropsychological assessment : Stroop task
Stroop task is an interference task assessing cognitive inhibitory control. This "paper-and-pencil" task aims to evaluate the inhibition of an automated process such as reading by asking participants to name the color of color names written in a different color ink. This test is non-invasive.
Neuropsychological assessment : Go No Go task
Go No Go task assessing motor inhibitory control. This computer-based task is designed to evaluate motor inhibition by asking participants to respond to a stimulus as quickly as possible by inhibiting another distractor stimulus. This test is non-invasive.

Locations

Country Name City State
France Centre Référent pour l'Anorexie et les Troubles du Comportement Alimentaire Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inhibition processes assessment - the Stroop task, Execution time Execution time in the Stroop task 1 day
Primary Inhibition processes assessment - the Stroop task, Errors Errors in the Stroop task 1 day
Primary Inhibition processes assessment - the Go No Go task, Execution time Execution time in the Go No Go task. 1 day
Primary Inhibition processes assessment - the Go No Go task, Variability of execution time Variability of execution time in the Go No Go task 1 day
Primary Inhibition processes assessment - the Go No Go task, Errors Errors in the Go No Go task 1 day
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