Binges and Neural Variability

Binge-Eating Disorder Clinical Trial

— BEDVAR  

Official title:

What is Driving the Binge in Binge Eating Disorder? Variability in Brain Response to Reward and the Escalation of Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184856
• Other study ID #: BEDVAR
• Status: Completed
• Start date: December 6, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2021
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Diagnostic Test:
• fMRI
(Imaging while) performing reward related tasks.

Locations

Country	Name	City	State
Germany	Psychological Institute, University of Tübingen	Tübingen	Deutschland (deu)

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Else Kröner Fresenius Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability in blood-oxygen-level dependent (BOLD) signalling in the NAcc during effort allocation task	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.	100 min
Primary	Trial-to-trial variability in reward seeking in an effort allocation task	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.	40 min
Primary	Variability in BOLD signalling in the NAcc for food-cue reactivity	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.	15
Secondary	Variability in BOLD signalling in the NAcc during non-food-cue reactivity	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.	5