Anorexia NervosaNCT04583774
Developing an EEG Paradigm to Study Prediction Error in Anorexia Nervosa
A study testing Prediction error tasks in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
Trial summary
Adolescent anorexia nervosa (AN) is an eating disorder associated with intense fear of weight gain, food refusal, and severe weight loss. AN is the third most common chronic illness among adolescent females with a mortality rate 12 times higher than expected for females 15-24 years old. Read more about this study
- Who is it for?
- Ages 11 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Prediction error tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Controls
- Females ages 11 - 17 years
- Healthy body weight between 90 and 110 % average body weight.
- Edinburgh Handedness Inventory Revised (EHI-R) LQ* score > +200
- English is primary language spoken
- Restricting Type Anorexia Nervosa
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- Females ages 11 - 17 years
- Diagnostic criteria. Current diagnosis of AN, including being underweight below 17.5 body mass index (BMI, kg/m2), will have a severe fear of weight gain, body image distortion and absence of the menstrual cycle over three consecutive months (if applicable).
- First 1-2 weeks in treatment at The University of California San Diego Eating Disorders Center for Treatment and Research or Rady Children's Hospital San Diego Medical Behavioral Unit.
- Restricting subtype, that is without binge/purge behaviors
- Edinburgh Handedness Inventory Revised (EHI-R) LQ* score > +200
- English is primary language spoken
Who cannot join
- Healthy Controls
- Current pregnancy or breast feeding within last 3 months
- Illiterate/Blind individuals
- First degree relative with current or past eating disorder
- Current Medications other than BCP or IUD
- Past or present Axis I psychiatric disorder including substance or alcohol use disorder as determined through PI interview and MINI-Kid clinical interview
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- Major Medical illness (as determined through medical history in bioscreen and PI interview) such as:
- Conditions that are life threatening:
- cancer
- heart disease
- stroke
- HIV/AIDS
- Seizure Disorders
- Conditions that are life threatening Conditions that cause serious disability without necessarily being life threatening:
- stroke
- closed head or spinal cord injuries
- mental retardation
- congenital malformations.
- Conditions that cause significant pain or discomfort that can cause serious interruptions to life activities:
- severe allergies
- migraine
- arthritis
- sickle cell disease
- Conditions that require major commitments of time and effort from care-givers for a substantial period of time:
- mobility disorders
- blindness
- Alzheimer's disease and other dementias
- chronic obstructive pulmonary disease
- paraplegia or quadriplegia
- Down's syndrome
- depression
- Conditions that may require frequent monitoring:
- diabetes
- conditions requiring anticoagulation treatment
- severe asthma
- severe allergies
- schizophrenia and other psychotic illnesses.
- Conditions that predict or are associated with severe consequences:
- hypertension (associated with heart disease)
- depression (associated with suicide)
- diabetes (associated with blindness, kidney failure)
- alcohol and other substance abuse (associated with intentional and unintentional injuries).
- Recent history of suspected substance abuse or a lifetime history of psychostimulant abuse and/or dependence
- Metal implants or braces (as determined through fMRI screening form)
- Anorexia Nervosa
- Pregnancy or breast feeding within last 3 months
- Lifetime history of bipolar disorder or psychosis
- Illiterate/Blind individuals
- Use of an anti-psychotic or other dopamine acting medication including stimulants within the past week at time of MRI
- Recent history of substance abuse or dependence (within the last month)
- Major Medical illness (as determined through medical history in bioscreen and PI interview) such as:
- Conditions that are life threatening:
- cancer
- heart disease
- stroke
- HIV/AIDS
- Seizure Disorders
- Conditions that are life threatening Conditions that cause serious disability without necessarily being life threatening:
- stroke
- closed head or spinal cord injuries
- mental retardation
- congenital malformations.
- Conditions that cause significant pain or discomfort that can cause serious interruptions to life activities:
- severe allergies
- migraine
- arthritis
- sickle cell disease
- Conditions that require major commitments of time and effort from care-givers for a substantial period of time:
- mobility disorders
- blindness
- Alzheimer's disease and other dementias
- chronic obstructive pulmonary disease
- paraplegia or quadriplegia
- Down's syndrome
- Conditions that may require frequent monitoring:
- diabetes
- conditions requiring anticoagulation treatment
- severe asthma
- severe allergies
- schizophrenia and other psychotic illnesses.
- Conditions that predict or are associated with severe consequences:
- hypertension (associated with heart disease)
- diabetes (associated with blindness, kidney failure)
- alcohol and other substance abuse (associated with intentional and unintentional injuries) within the last month
- 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: Developing a Computational Electroencephalogram (EEG) Paradigm to Study Prediction Error in Anorexia Nervosa
Adolescent anorexia nervosa (AN) is an eating disorder associated with intense fear of weight gain, food refusal, and severe weight loss. AN is the third most common chronic illness among adolescent females with a mortality rate 12 times higher than expected for females 15-24 years old. Little is known about biomarkers in adolescent AN.
Neuroimaging studies have repeatedly suggested altered reward processing in AN including in studies using the dopamine associated prediction error (PE) model. The brain PE response is elicited during unexpected receipt or omission of reward stimuli and thought to reflect the functionality of brain dopamine circuits. This is an important research direction as the dopamine system can be manipulated pharmacologically. In ill and recovered adult AN, unexpected or randomly applied sucrose taste stimuli evoked higher insular and striatal responses and unexpected omission or receipt of monetary or taste reward was associated with a similar response pattern in adolescent AN. PE was also inversely related to weight gain in treatment. Thus, PE brain response promises to be an important biological marker for adolescent AN with predictive value for treatment outcome. However, functional brain imaging is costly, prohibitive for instance for individuals with braces or other metal in their body and only available at certain centers. In order to study PE in AN in larger scale studies, a more practical approach and method need to be developed. In this application, we will use the exploratory/developmental R21 mechanism to develop a study protocol using electroencephalography (EEG) to study PE signals in adolescent AN. Recent studies in healthy individuals support that this is a valid approach.
Read more
Our primary goal for this study is to test the feasibility of the use of EEG for prediction error and reversal learning studies in AN with the longer term goal of replacing fMRI that is costly and associated with frequent participant rule out.
In Aim 1. we test the feasibility of adapting a computational taste PE reinforcement learning paradigm from fMRI to EEG in adolescents with AN and healthy controls. We expect that we will find internal consistency of taste PE brain response across fMRI and EEG in adolescents with AN as well as age-matched healthy controls, within each group. We further expect that we will find preliminary evidence that the EEG paradigm will be able to discriminate the AN group from the HC adolescents based on feedback related negativity and higher event-related potential amplitudes, which will correlate with fMRI PE brain response.
In Aim 2., we test whether a monetary PE paradigm will show similar EEG brain response as taste PE in Aim 1. to establish the generalizability of EEG taste and non-taste paradigms.
The development of an EEG based reward PE study paradigm will enable us in the future to conduct large-scale studies that will be less costly and independent from brain imaging centers that are only available to a small subset of adolescents with AN.
- Conditions
- Anorexia Nervosa
- Being tested
- Prediction error tasks
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction error tasksOther
The intervention involves two tasks, one that involves taste stimuli and another that involves monetary stimuli, and test their impact o brain response in electro encephalography (EEG) and functional magnetic resonance imaging (fMRI)
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa Group | Other | Participants with anorexia nervosa Receives: Other: Prediction error tasks |
| Healthy Control Group | Other | Participants who are considered to be healthy controls Receives: Other: Prediction error tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Reward Prediction Error Brain Response using functional Magnetic Resonance Imaging (fMRI) and Electroencephalography (EEG)
Study participants will undergo an fMRI session during which they perform a taste reward prediction error paradigm. Blood oxygen-level dependent (BOLD) functional activity will be acquired during the task. The prediction error signal will be modeled based on trial sequence. The same individuals will perform the prediction error task during EEG. fMRI and EEG results for brain regions will be compared and tested for correlations between modalities.
Measured: Immediate during brain scanning
Reward Prediction Error Brain Response using Electroencephalography (EEG) to separate healthy controls from individuals with anorexia nervosa.
We will test whether regional brain EEG recordings from the taste prediction error paradigm in Outcome 1 can distinguish individuals with anorexia nervosa from healthy controls.
Measured: Immediate during brain scanning
Monetary Reward Prediction Error Brain Response using EEG will show similar regional brain response compared to taste prediction error response.
Study participants will undergo an EEG session during which they perform a monetary reward prediction error paradigm. The results will be compared to the taste paradigm results from Outcome 1.
Measured: Immediate during brain scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start9 Feb 2021
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 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
- NCT04583774
- Sponsor's protocol ID
- 191785
- Status last verified
- Jul 2026
- First submitted
- 25 Sep 2020
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Computational Electroencephalogram (EEG) Paradigm to Study Prediction Error in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT04583774
- Acronym / sponsor ID
- 191785
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Oct 2020 (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.
Adolescent anorexia nervosa (AN) is an eating disorder associated with intense fear of weight gain, food refusal, and severe weight loss. AN is the third most common chronic illness among adolescent females with a mortality rate 12 times higher than expected for females 15-24 years old. Little is known about biomarkers in adolescent AN.
Neuroimaging studies have repeatedly suggested altered reward processing in AN including in studies using the dopamine associated prediction error (PE) model. The brain PE response is elicited during unexpected receipt or omission of reward stimuli and thought to reflect the functionality of brain dopamine circuits. This is an important research direction as the dopamine system can be manipulated pharmacologically. In ill and recovered adult AN, unexpected or randomly applied sucrose taste stimuli evoked higher insular and striatal responses and unexpected omission or receipt of monetary or taste reward was associated with a similar response pattern in adolescent AN. PE was also inversely related to weight gain in treatment. Thus, PE brain response promises to be an important biological marker for adolescent AN with predictive value for treatment outcome. However, functional brain imaging is costly, prohibitive for instance for individuals with braces or other metal in their body and only available at certain centers. In order to study PE in AN in larger scale studies, a more practical approach and method need to be developed. In this application, we will use the exploratory/developmental R21 mechanism to develop a study protocol using electroencephalography (EEG) to study PE signals in adolescent AN. Recent studies in healthy individuals support that this is a valid approach.
Our primary goal for this study is to test the feasibility of the use of EEG for prediction error and reversal learning studies in AN with the longer term goal of replacing fMRI that is costly and associated with frequent participant rule out.
In Aim 1. we test the feasibility of adapting a computational taste PE reinforcement learning paradigm from fMRI to EEG in adolescents with AN and healthy controls. We expect that we will find internal consistency of taste PE brain response across fMRI and EEG in adolescents with AN as well as age-matched healthy controls, within each group. We further expect that we will find preliminary evidence that the EEG paradigm will be able to discriminate the AN group from the HC adolescents based on feedback related negativity and higher event-related potential amplitudes, which will correlate with fMRI PE brain response.
In Aim 2., we test whether a monetary PE paradigm will show similar EEG brain response as taste PE in Aim 1. to establish the generalizability of EEG taste and non-taste paradigms.
The development of an EEG based reward PE study paradigm will enable us in the future to conduct large-scale studies that will be less costly and independent from brain imaging centers that are only available to a small subset of adolescents with AN.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa Group | Other | Other: Prediction error tasksParticipants with anorexia nervosa |
| Healthy Control Group | Other | Other: Prediction error tasksParticipants who are considered to be healthy controls |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Healthy Controls
- Females ages 11 - 17 years
- Healthy body weight between 90 and 110 % average body weight.
- Edinburgh Handedness Inventory Revised (EHI-R) LQ* score > +200
- English is primary language spoken
Key exclusion criteria (85 listed)
- Healthy Controls
- Current pregnancy or breast feeding within last 3 months
- Illiterate/Blind individuals
- First degree relative with current or past eating disorder
- Current Medications other than BCP or IUD
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 |
|---|---|---|
| Prediction error tasksThe intervention involves two tasks, one that involves taste stimuli and another that involves monetary stimuli, and test their impact o brain response in electro encephalography (EEG) and functional magnetic resonance imaging (fMRI) | Other | Anorexia Nervosa Group, Healthy Control Group |
Primary outcome
Correlation between Reward Prediction Error Brain Response using functional Magnetic Resonance Imaging (fMRI) and Electroencephalography (EEG)
Time frame: Immediate during brain scanning
Study participants will undergo an fMRI session during which they perform a taste reward prediction error paradigm. Blood oxygen-level dependent (BOLD) functional activity will be acquired during the task. The prediction error signal will be modeled based on trial sequence. The same individuals will perform the prediction error task during EEG. fMRI and EEG results for brain regions will be compared and tested for correlations between modalities.
Reward Prediction Error Brain Response using Electroencephalography (EEG) to separate healthy controls from individuals with anorexia nervosa.
Time frame: Immediate during brain scanning
We will test whether regional brain EEG recordings from the taste prediction error paradigm in Outcome 1 can distinguish individuals with anorexia nervosa from healthy controls.
Monetary Reward Prediction Error Brain Response using EEG will show similar regional brain response compared to taste prediction error response.
Time frame: Immediate during brain scanning
Study participants will undergo an EEG session during which they perform a monetary reward prediction error paradigm. The results will be compared to the taste paradigm results from Outcome 1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. No plan to share IPD
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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 Prediction error tasks in people with 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 12 inclusion and 85 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation between Reward Prediction Error Brain Response using functional Magnetic Resonance Imaging (fMRI) and Electroencephalography (EEG) (time frame: Immediate during brain scanning). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.