Skip to main content
Clinical Trials/NCT05834816
NCT05834816
Terminated
Not Applicable

Neural Mechanisms of Negative Affect and Neurofeedback in Anorexia Nervosa

University of California, San Diego1 site in 1 country2 target enrollmentApril 26, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anorexia Nervosa
Sponsor
University of California, San Diego
Enrollment
2
Locations
1
Primary Endpoint
Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a body size estimation task
Status
Terminated
Last Updated
last year

Overview

Brief Summary

Anorexia nervosa (AN) and atypical AN (AAN) are severe psychiatric illnesses associated with high disease burden including high treatment costs and excessive mortality rates. Primary characteristics of AN and AAN are food restriction, associated fear of weight gain, and a disturbance in how one's body weight or shape is experienced.The underlying neural mechanisms for the core illness behaviors of food restriction and body size overestimation in anorexia nervosa and atypical anorexia nervosa are not well understood.

This project will use neurofeedback and advanced psychophysical methods to assess and moderate the neural and behavioral responses to stress and relate those results to the naturalistic environment. The results will guide the development of novel interventions.

Detailed Description

The overall strategy is a cross-sectional study, involving 3 subject groups, each subject studied on two study days (one negative and one neutral affect day, randomized), one week apart; on both study days subjects will undergo functional magnetic resonance imaging (fMRI) during which they complete tasks for 1) neurofeedback-reward learning and 2) body size estimation. Before and after each scan, and in the week between scans, subjects will be assessed for positive and negative affect and how it affects food intake.

Registry
clinicaltrials.gov
Start Date
April 26, 2023
End Date
March 25, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guido Frank

Professor

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • Healthy Controls (HC)
  • Individuals aged 18-45 years
  • Healthy body weight between 90 and 110 % average body weight since puberty.
  • Regular monthly menstrual cycle (if applicable)
  • Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200
  • All ethnic backgrounds
  • English is primary language spoken
  • Anorexia Nervosa (AN)
  • Age 18-45 years old
  • Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200

Exclusion Criteria

  • Healthy Controls (HC)
  • Current pregnancy or breast feeding within last 3 months
  • First degree relative with current or past eating disorder
  • Psychiatric Medication use such as selective serotonin reuptake inhibitors (SSRIs), atypical antipsychotics, etc.
  • Past or present Axis I psychiatric disorder including substance or alcohol use disorder as determined through structured clinical interview
  • History of significant head trauma
  • Indication of intellectual disability or autism spectrum disorder
  • Major Medical illness that requires medication or have significant impact on subject's life such as: diabetes, Alzheimer's disease or dementia, stroke, learning disability, mobility disorders, cancer, high blood pressure, etc. (to be determined through biological screening form and interview with principal investigator (PI)
  • Recent history of suspected substance abuse or a lifetime history of psychostimulant abuse and/or dependence
  • Contraindications to magnetic resonance imaging (MRI) including metal implants or braces (as determined through fMRI screening form)

Outcomes

Primary Outcomes

Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a body size estimation task

Time Frame: Difference in brain response between the neutral and stress condition, up to 9 days

Activation in the brain during a body size estimation task will be measured using functional MRI (fMRI) after a neutral and stressful task.

Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a taste reward task

Time Frame: Difference in brain response between the neutral and stress condition, up to 9 days

Activation in the brain during a taste reward task will be measured using functional MRI (fMRI) after a neutral and stressful task.

Secondary Outcomes

  • Ecological Momentary Assessment (EMA)(Up to 9 days)

Study Sites (1)

Loading locations...

Similar Trials