Clinical trial NCT04184856: Binges and Neural Variability
Official title: What is Driving the Binge in Binge Eating Disorder? Variability in Brain Response to Reward and the Escalation of Consumption
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binge-Eating Disorder
Keywords: reward sensitivity
neuroimaging
variability
ecological momentary assessment (EMA)
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Else Kröner Fresenius Foundation
First posted: 2019-12-04
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The control group will consist of residents of the general area around Tübingen, Germany.

BED patients will be recruited mainly from the outpatient clinic of the Department of Clinical Psychology of Tübingen, Germany.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Variability in blood-oxygen-level dependent (BOLD) signalling in the NAcc during effort allocation task
timeFrame: 100 min
measure: Trial-to-trial variability in reward seeking in an effort allocation task
timeFrame: 40 min
measure: Variability in BOLD signalling in the NAcc for food-cue reactivity
timeFrame: 15
Secondary outcomes:
measure: Variability in BOLD signalling in the NAcc during non-food-cue reactivity
timeFrame: 5
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Psychological Institute, University of Tübingen
state: Deutschland (deu)
Study officials:
affiliation: University Hospital Tuebingen
name: Nils B Kroemer, Dr
role: PRINCIPAL_INVESTIGATOR
References: