Neurofeedback for Anorexia Nervosa

Overseen By Guido Frank, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: SSRIs, Atypical antipsychotics

Disqualifiers: Pregnancy, Bipolar, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

2 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Guido Frank, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for individuals aged 18-45 with Anorexia Nervosa or Atypical Anorexia, who are right-handed (EHI-R LQ > +200), speak English primarily, and women must have a regular menstrual cycle. Excluded are those with psychiatric disorders, substance abuse issues, medical conditions affecting eating/weight, pregnancy/breastfeeding in the last 3 months, contraindications to MRI, or significant head trauma.

Inclusion Criteria

English is primary language spoken

You have symptoms of anorexia nervosa, but your weight is not significantly below normal.

My weight has been within 10% of the average since puberty.

Exclusion Criteria

You have been diagnosed with a learning disability or autism.

One of your close family members (like a sibling or parent) has or had an eating disorder.

I have a major illness like diabetes or high blood pressure that affects my daily life.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Study Days

Participants undergo fMRI during tasks for neurofeedback-reward learning and body size estimation on two study days, one week apart

2 weeks

2 visits (in-person)

Assessment

Participants are assessed for positive and negative affect and how it affects food intake before and after each scan, and in the week between scans

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the study days

4 weeks

Treatment Details

Interventions

• Negative Affect Task

Trial Overview The study aims to understand how stress affects people with anorexia using neurofeedback and psychophysical methods. It will assess neural and behavioral responses to stress in participants with AN or AAN compared to healthy controls within the same age range.

Participant Groups

Group I: Behavioral Experimental Treatment 1 Intervention

Negative Affect Task

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+