Anorexia NervosaNCT05834816
Stress and Neurofeedback in Anorexia Nervosa
A study testing Negative Affect Task in people with Anorexia Nervosa and Atypical Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Atypical Anorexia Nervosa
- What is being tested?
- Negative Affect Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2023to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92121
About this study
Official title: 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.
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.
- Conditions
- Anorexia Nervosa, Atypical Anorexia Nervosa
- Being tested
- Negative Affect Task
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Affect TaskBehavioural
Also called Functional Magnetic Resonance Brain Imaging Stress Task
fMRI stress task
| Study group | Role | What they receive |
|---|---|---|
| Behavioral | Experimental | Negative Affect Task Receives: Behavioral: Negative Affect Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Activation in the brain during a body size estimation task will be measured using functional MRI (fMRI) after a neutral and stressful task.
Measured: 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.
Measured: Up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start26 Apr 2023
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Why it stopped: No funding received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Frank, University of California, San Diego
- Investigators
- Guido Frank, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834816
- Sponsor's protocol ID
- 805807
- Status last verified
- Mar 2025
- First submitted
- 4 Apr 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34190963Gardner 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 8682909Gardner 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 15190703Misaki 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Negative Affect and Neurofeedback in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT05834816
- Acronym / sponsor ID
- 805807
- Conditions
- Anorexia Nervosa, Atypical Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funding received
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Behavioral | Experimental | Behavioral: Negative Affect TaskNegative Affect Task |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Affect TaskAlso: Functional Magnetic Resonance Brain Imaging Stress TaskfMRI stress task | Behavioural | Behavioral |
Primary outcome
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.
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.
1 secondary outcome
Ecological Momentary Assessment (EMA)
Time frame: Up to 9 days
Results and safety
The study was stopped early (reason given: No funding received). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 34190963Frank 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.
- Background: PubMed 8682909Gardner 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.
- Background: PubMed 15190703Gardner 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.
- Background: PubMed 30175041Misaki 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.
- Individual participant dataSharing planned: No
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Frank, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Affect Task in people with Anorexia Nervosa and Atypical Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No funding received). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05834816, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.