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Stress and Neurofeedback in Anorexia Nervosa

Primary Purpose

Anorexia Nervosa, Atypical Anorexia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative Affect Task
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of California San DiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral

Arm Description

Negative Affect Task

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 4, 2023
Last Updated
May 3, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05834816
Brief Title
Stress and Neurofeedback in Anorexia Nervosa
Official Title
Neural Mechanisms of Negative Affect and Neurofeedback in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
March 31, 2029 (Anticipated)
Study Completion Date
March 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Atypical Anorexia Nervosa

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral
Arm Type
Experimental
Arm Description
Negative Affect Task
Intervention Type
Behavioral
Intervention Name(s)
Negative Affect Task
Other Intervention Name(s)
Functional Magnetic Resonance Brain Imaging Stress Task
Intervention Description
fMRI stress task
Primary Outcome Measure Information:
Title
Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a taste reward task
Description
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
Title
Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a body size estimation task
Description
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 Outcome Measure Information:
Title
Ecological Momentary Assessment (EMA)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Shott, BS
Phone
858-246-5272
Email
mshott@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Guido Frank, MD
Phone
858-246-2053
Email
gfrank@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Frank, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan E Shott, BS
Phone
858-246-5272
Email
mshott@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Guido Frank, MD
Email
gfrank@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Guido Frank, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34190963
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.
Results Reference
background
PubMed Identifier
8682909
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.
Results Reference
background
PubMed Identifier
15190703
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.
Results Reference
background
PubMed Identifier
30175041
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.
Results Reference
background

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Stress and Neurofeedback in Anorexia Nervosa

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