- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834816
Stress and Neurofeedback in Anorexia Nervosa
Neural Mechanisms of Negative Affect and Neurofeedback in Anorexia Nervosa
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guido Frank, MD
- Phone Number: 858-246-2053
- Email: gfrank@health.ucsd.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92121
- Recruiting
- University of California San Diego
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral
Negative Affect Task
|
fMRI stress task
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Difference in brain response between the neutral and stress condition, up to 9 days
|
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.
|
Difference in brain response between the neutral and stress condition, up to 9 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ecological Momentary Assessment (EMA)
Time Frame: Up to 9 days
|
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
|
Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 805807
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anorexia Nervosa
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Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Fundació La Marató de TV3RecruitingAnorexia Nervosa | Anorexia Nervosa in Remission | Anorexia Nervosa Restricting TypeSpain
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Duke UniversityCompletedAdolescent Anorexia Nervosa | Subthreshold Anorexia NervosaUnited States
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Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH) and other collaboratorsCompletedAnorexia Nervosa | Anorexia | Eating Disorder | Eating Disorders in Adolescence | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa Restricting Type | Anorexia in ChildrenUnited States
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University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
-
Umeå UniversityActive, not recruitingAnorexia Nervosa | Anorexia in Adolescence | Anorexia Nervosa, AtypicalSweden
-
Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
The Miriam HospitalUnknownEating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia Nervosa Restricting TypeUnited States
-
University Hospital, AkershusRådgivning om SpiseforstyrrelserEnrolling by invitationAnorexia Nervosa | Atypical Anorexia NervosaNorway
Clinical Trials on Negative Affect Task
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University of California, San DiegoUniversity of Colorado, Denver; Sanford ResearchRecruitingObesity | Binge-Eating Disorder | Bulimia Nervosa | Eating DisorderUnited States
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University of California, Los AngelesSouthern Methodist UniversityRecruiting
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University of California, Los AngelesSouthern Methodist UniversityCompleted
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University of Colorado, BoulderNational Institute of Mental Health (NIMH)CompletedPhysical Activity | Affect
-
University of UtahNational Cancer Institute (NCI); University of MichiganRecruitingTobacco Smoking | Current SmokerUnited States
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Chang Gung Memorial HospitalUnknown
-
Texas A&M UniversityUniversity of Central FloridaCompleted
-
Massachusetts General HospitalCompleted
-
University of Alabama, TuscaloosaRecruitingAffective Symptoms | EmpathyUnited States
-
Hospices Civils de LyonRecruitingOptical PhenomenaFrance