Neurofeedback for Anorexia Nervosa

MS
GF
Overseen ByGuido Frank, MD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how neurofeedback, which provides real-time feedback on brain activity, can assist individuals with anorexia nervosa (AN) and atypical anorexia nervosa (AAN) in managing stress and altering behaviors related to food restriction and body image. By understanding the brain's response to stress, researchers aim to develop new treatments for these eating disorders. Participants may be suitable if they have been diagnosed with AN or AAN, experience significant weight concerns or body image issues, and are willing to participate in brain activity feedback sessions using the Negative Affect Task. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to innovative treatments for eating disorders.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but if you are a healthy control, you cannot be on psychiatric medications like SSRIs or antipsychotics. For those with anorexia nervosa or atypical anorexia nervosa, the protocol does not mention medication restrictions.

What prior data suggests that this neurofeedback method is safe for treating anorexia nervosa?

Research shows that the Negative Affect Task, used in treating anorexia nervosa, examines how emotions and stress influence eating habits. Studies indicate that negative feelings often rise before episodes of lost eating control but tend to decrease afterward. Specific safety information on the Negative Affect Task itself is not available. Since this trial is in a "Not Applicable" phase, the focus is on understanding how the treatment works rather than proving its safety, suggesting limited safety information. Participants should consider this when deciding whether to join the trial.12345

Why are researchers excited about this trial?

Researchers are excited about the Negative Affect Task for anorexia nervosa because it offers a fresh approach to treatment by using neurofeedback to target emotional regulation. Unlike standard treatments like therapy and medication, which focus primarily on eating behaviors and weight gain, this method aims to directly address the emotional triggers that contribute to the disorder. By using real-time feedback to help patients manage negative emotions, this approach could provide a more holistic and potentially faster path to recovery, making it a promising option for those who struggle with traditional treatments.

What evidence suggests that this neurofeedback method is effective for anorexia nervosa?

Research shows that people with anorexia nervosa (AN) often struggle with decision-making, particularly when underweight. Studies also find that negative emotions can exacerbate these decision-making difficulties. Teenagers with AN tend to fixate on thoughts about food when feeling upset. Additionally, negative emotions can impair their ability to remember and process information. These findings suggest that addressing negative emotions, such as through the Negative Affect Task studied in this trial, could enhance decision-making and coping skills in people with AN.46789

Who Is on the Research Team?

Dr. Guido K. Frank, MD | San Diego, CA ...

Guido Frank, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.
See 7 more

Exclusion Criteria

You have been diagnosed with a learning disability or autism.
I have a major illness like diabetes or high blood pressure that affects my daily life.
One of your close family members (like a sibling or parent) has or had an eating disorder.
See 14 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: BehavioralExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Citations

The Influence of Negative Affect and Food Stimuli on ...The findings indicate automatic and more efficient switching towards preoccupation with food among adolescents with AN while experiencing negative emotion.
The Influence of Negative Affect on Working Memory Updating ...The findings indicate that exposure to negative emotion and food stimuli separately compromise working memory updating in adolescents with AN.
Negative mood induction effects on problem-solving task in ...After a negative mood induction, women with BED provided significantly less effective problem-solving strategies compared to HCs and women with ...
The Role of Negative Affect in Emotional Processing ...Patients with purging and restrictive eating symptomatology showed higher levels of arousal and less dominance over the emotions experienced, ...
Altered value-based decision-making in anorexia nervosaPoorer performance on value-based decision-making is frequently observed in anorexia nervosa. Decision-making deficits are greater in low weight compared to ...
Safety Behaviors Exacerbate Eating Disorder Fears - PMCThe present study tested to what extent eating disorder safety behaviors increase threat perception in individuals with and without an eating disorder.
Trajectories of negative affect prior to and following ...Negative affect increased prior to loss of control eating—but not dietary restriction or overeating—and decreased following all DEBs. Further, the magnitude of ...
Avoidance in Anorexia Nervosa: Towards a research agendaThe perceived threats trigger avoidance and safety behaviors like highly restrictive eating, strict eating rules, vomiting and body checking, to ...
Anxiety matters: a pilot lab study into food, weight, and virtual ...Patients were found to be more anxious about food and weight related stimuli, consumed fewer calories, and reacted more negatively when they imagined that ...
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