Clinical trial NCT05834816: Stress and Neurofeedback in Anorexia Nervosa
Official title: Neural Mechanisms of Negative Affect and Neurofeedback in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anorexia Nervosa
Atypical Anorexia Nervosa
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: BASIC_SCIENCE

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.

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
* 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:

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)

Primary outcomes:
measure: Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a taste reward task
timeFrame: Difference in brain response between the neutral and stress condition, up to 9 days
measure: Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a body size estimation task
timeFrame: Difference in brain response between the neutral and stress condition, up to 9 days
Secondary outcomes:
measure: Ecological Momentary Assessment (EMA)
timeFrame: Up to 9 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Guido Frank, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.