Stress and Neurofeedback in Anorexia Nervosa (NCT05834816) | Clinical Trial Compass
TerminatedNot Applicable
Stress and Neurofeedback in Anorexia Nervosa
Stopped: No funding received
United States2 participantsStarted 2023-04-26
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Ind…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a taste reward task
Timeframe: Difference in brain response between the neutral and stress condition, up to 9 days
2
Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a body size estimation task
Timeframe: Difference in brain response between the neutral and stress condition, up to 9 days