Binges and Neural Variability

NCT04184856 | Completed

• 1 other identifier: BEDVAR
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder

Keywords

reward sensitivity; neuroimaging; variability; ecological momentary assessment (EMA)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

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

  5

Study Arms (3)

Binge eating disorder (BED) patients

Individuals with BED diagnosis.

Diagnostic Test: fMRI

non-BED controls

Individuals that do not experience binges

Diagnostic Test: fMRI

subsyndromal BED controls

individuals that experience binges but do not fulfill the requirements for BED diagnosis.

Diagnostic Test: fMRI

Interventions

fMRI DIAGNOSTIC_TEST

(Imaging while) performing reward related tasks.

Binge eating disorder (BED) patients; non-BED controls; subsyndromal BED controls

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Else Kröner Fresenius Foundation: collaborator

Study Sites (1)

Psychological Institute, University of Tübingen

Tübingen, Deutschland (deu), 72070, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nils B Kroemer, Dr

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: December 4, 2019
• Study Start: December 6, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-04

Locations

DE (1)