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OpenTrials
Completed

NCT Number: NCT04184856

Binges and Neural Variability

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.

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Key information

Conditions

Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Psychological Institute, University of Tübingen

Tübingen, Deutschland (deu), 72070, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fMRI

Diagnostic Test

(Imaging while) performing reward related tasks.

Primary outcomes

  1. Variability in blood-oxygen-level dependent (BOLD) signalling in the NAcc during effort allocation task

    Time frame: 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.

  2. Trial-to-trial variability in reward seeking in an effort allocation task

    Time frame: 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.

  3. Variability in BOLD signalling in the NAcc for food-cue reactivity

    Time frame: 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 outcomes

  1. Variability in BOLD signalling in the NAcc during non-food-cue reactivity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Else Kröner Fresenius Foundation

Registry information

Official study title

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

Acronym: BEDVAR

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2019
Registry last updated
Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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