Stress and Neurofeedback in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Neural Mechanisms of Negative Affect and Neurofeedback in Anorexia Nervosa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05834816
• Other study ID #: 805807
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 26, 2023
• Est. completion date: March 31, 2029

Study information

• Verified date: June 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: March 31, 2029
• Est. primary completion date: March 31, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Atypical Anorexia Nervosa

Intervention

Behavioral:
• Negative Affect Task
fMRI stress task

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Difference in brain response between the neutral and stress condition, up to 9 days
Primary	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.	Difference in brain response between the neutral and stress condition, up to 9 days
Secondary	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.	Up to 9 days