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TerminatedNCT05834816Updated Mar 30, 2025

Stress and Neurofeedback in Anorexia Nervosa

An interventional study of Negative Affect Task in Anorexia Nervosa and Atypical Anorexia Nervosa, sponsored by University of California, San Diego. Terminated at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Basic science

Why this study was terminated
No funding received
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anorexia Nervosa
  • Atypical Anorexia Nervosa
03

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 2 is below the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
  • All ethnic backgrounds
  • Current diagnosis of anorexia nervosa, including being underweight, will have a severe fear of weight gain, body image distortion and absence of the menstrual cycle over three consecutive months.
  • English is primary language spoken

Atypical Anorexia Nervosa (AAN)

  • Age 18-45 years old
  • Edinburgh Handedness Inventory Revised (EHI-R) LQ* score > +200
  • All ethnic backgrounds
  • Meets the criteria for anorexia nervosa except despite significant weight loss, the individual's weight is within or above the normal range
  • English is primary language spoken

Exclusion criteria

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)

Anorexia Nervosa (AN)

  • Pregnancy or breast feeding within last 3 months
  • Lifetime history of bipolar I disorder or psychosis
  • Current substance abuse or dependence in the past 3 months
  • Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders
  • Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight
  • History of significant head trauma
  • Indication of intellectual disability or autism spectrum disorder
  • Electrolyte, blood count or kidney or liver function abnormalities
  • Contraindications to MRI including metal implants or braces (as determined through fMRI screening form)

Atypical Anorexia Nervosa (AAN)

  • Pregnancy or breast feeding within last 3 months
  • Lifetime history of bipolar disorder or psychosis
  • Current substance abuse or dependence in the past 3 months
  • Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders
  • Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight
  • History of significant head trauma
  • Indication of intellectual disability or autism spectrum disorder
  • Electrolyte, blood count or kidney or liver function abnormalities
  • Contraindications to MRI including metal implants or braces (as determined through fMRI screening form)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Behavioral

    Negative Affect Task

    Behavioral: Negative Affect Task

Interventions

  • BehavioralNegative Affect Task

    fMRI stress task

    Also known as: Functional Magnetic Resonance Brain Imaging Stress Task

06

What researchers measure

Primary outcomes

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

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

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

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

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

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

Secondary outcomes

  1. Ecological Momentary Assessment (EMA)

    Ecological Momentary Assessment (EMA) will be used to test food restriction and body size estimation in the natural environment and in relation to daily stress.

    Time frame: Up to 9 days

07

Study locations

1 site
  • University of California San Diego
    San Diego, California 92121, United States
08

References and documents

Publications

  • Frank GKW, Shott ME, Stoddard J, Swindle S, Pryor TL. Association of Brain Reward Response With Body Mass Index and Ventral Striatal-Hypothalamic Circuitry Among Young Women With Eating Disorders. JAMA Psychiatry. 2021 Oct 1;78(10):1123-1133. doi: 10.1001/jamapsychiatry.2021.1580. PubMed 34190963 ↗
  • Gardner RM, Bokenkamp ED. The role of sensory and nonsensory factors in body size estimations of eating disorder subjects. J Clin Psychol. 1996 Jan;52(1):3-15. doi: 10.1002/(SICI)1097-4679(199601)52:13.0.CO;2-X. PubMed 8682909 ↗
  • Gardner RM, Boice R. A computer program for measuring body size distortion and body dissatisfaction. Behav Res Methods Instrum Comput. 2004 Feb;36(1):89-95. doi: 10.3758/bf03195553. PubMed 15190703 ↗
  • Misaki M, Phillips R, Zotev V, Wong CK, Wurfel BE, Krueger F, Feldner M, Bodurka J. Real-time fMRI amygdala neurofeedback positive emotional training normalized resting-state functional connectivity in combat veterans with and without PTSD: a connectome-wide investigation. Neuroimage Clin. 2018 Aug 19;20:543-555. doi: 10.1016/j.nicl.2018.08.025. eCollection 2018. PubMed 30175041 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05834816
Lead sponsor
University of California, San Diego
Responsible party
Guido Frank (Professor, University of California, San Diego) — Principal investigator
First posted
Apr 28, 2023
Start date
Apr 26, 2023
Primary completion
Mar 25, 2025
Completion
Mar 25, 2025
Last update
Mar 30, 2025

Study contacts

Guido Frank, MD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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