Binges and Neural Variability

Completed

• Conditions: Binge-Eating Disorder
• Interventions: Diagnostic Test: fMRI

• Registration Number: NCT04184856
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

People who suffer from binge eating disorder experience recurrent episodes of binge eating.During these episodes, they consume an unusually large amount of food in a short amount of time and experience loss of control over eating. However, why such binge eating episodes occur is still largely unknown. This makes it difficult to develop targeted treatments. In this project, the experimenters are investigating the brain mechanisms that give rise to the disorder. They hypothesize that the binge eating episodes are due to an increased variability in reward processing, which they will assess repeatedly over days. They will test this hypothesis using mathematical models based on behavioural and MRI measurements that are related to the processing of rewards.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-11-29
• Study First Posted: 2019-12-04
• Study Start: 2019-12-06
• Status Verified: 2021-04
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Binge eating disorder diagnosis
• Subsyndromal binge eating (control)

Exclusion Criteria

• high risk of suicide
• co-occurring psychotic, bi-polar disorders, alcohol/substance dependence within the past six months
• lack of capacity for consent
• medical disorders that would affect weight and ability to participate
• insufficient German language skills (assessment will be in German)
• taking medication that would affect weight
• MRI exclusion criteria
• irremovable metal attached to the body (e.g. piercings)
• irremovable medical devices (e.g. pacemakers)
• any trauma or surgery which may have left ferromagnetic material in the body
• large tattoos
• pregnancy
• claustrophobia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
subsyndromal BED controls	fMRI	individuals that experience binges but do not fulfill the requirements for BED diagnosis.
non-BED controls	fMRI	Individuals that do not experience binges
Binge eating disorder (BED) patients	fMRI	Individuals with BED diagnosis.

Primary Outcome Measures

Name	Time	Method
Variability in blood-oxygen-level dependent (BOLD) signalling in the NAcc during effort allocation task	100 min	Variability of BOLD signal in the nucleus accumbens (NAcc) over time and between trials while performing an effort allocation task. The signal is measured through functional magnetic resonance imaging (fMRI) and variability is determined through model residuals.
Trial-to-trial variability in reward seeking in an effort allocation task	40 min	Variability of performance is an intra-individual measure, that is defined by the residuals of a linear mixed effects model of trial-to-trial performance on the effort allocation task.
Variability in BOLD signalling in the NAcc for food-cue reactivity	15	Variability of BOLD signal in the NAcc between blocks of food pictures. The signal is measured through fMRI and variability is determined through model residuals.

Secondary Outcome Measures

Name	Time	Method
Variability in BOLD signalling in the NAcc during non-food-cue reactivity	5	Variability of BOLD signal in the NAcc between blocks of non-food pictures. The signal is measured through fMRI and variability is determined through model residuals.

Trial Locations

Locations (1)

Psychological Institute, University of Tübingen; 🇩🇪 Tübingen, Deutschland (deu), Germany