Neurofeedback for Bulimia

Overseen By Laura A Berner, Ph.D.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Major medical condition, Psychiatric disorder, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the effects of noninvasive prefrontal cortex (PFC) neurofeedback during eating in women with bulimia nervosa (BN) using a wearable brain imaging device, functional near-infrared spectroscopy (fNIRS). The investigators will examine how this training may influence inhibitory control and BN symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but ongoing medical treatment that may interfere with the study could exclude you from participating.

What data supports the effectiveness of the treatment Real fNIRS Neurofeedback and Sham-Control fNIRS Neurofeedback for Bulimia?

Research on similar treatments, like EEG neurofeedback, shows promise in reducing binge-eating episodes and improving decision-making in people with binge-eating disorder. Additionally, fNIRS neurofeedback has been shown to help regulate brain activity and improve symptoms in other conditions, suggesting potential benefits for eating disorders. ^{1 2 3 4 5}

Is neurofeedback using fNIRS safe for humans?

Functional near-infrared spectroscopy (fNIRS) neurofeedback is generally considered safe for humans, as it is noninvasive and has been used in various studies without major safety concerns. It has been applied in healthy individuals and clinical populations, such as those with ADHD and autism, showing potential for modulating brain activity without reported adverse effects. ^{1 4 5 6 7}

How does Real fNIRS Neurofeedback treatment for Bulimia differ from other treatments?

Real fNIRS Neurofeedback is unique because it uses real-time feedback to help patients regulate their brain activity, which is not a common approach in traditional bulimia treatments. This method focuses on directly modifying brain patterns associated with eating behaviors, offering a novel way to address the neurocognitive roots of the disorder. ^{3 4 5 8 9}

Research Team

Laura A Berner, Ph.D.

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for women aged 18 to 35 who have been diagnosed with bulimia nervosa and are within a certain weight range for their height. They must speak English but cannot be pregnant, planning pregnancy, or breastfeeding during the study. Those with allergies to meal ingredients, in specific psychotherapy, or with major medical conditions that could affect the study can't participate.

Inclusion Criteria

English-speaking

Currently between 85 and 130% of the expected weight for height

I am female.

Exclusion Criteria

Pregnancy or planned pregnancy, or lactation during the study period

Allergy to ingredients in the standardized meal or in the shake

I am currently in psychotherapy for an eating disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phone screening assessment

Baseline Assessment

Psychodiagnostic assessment and one in-person evaluation

1 week

1 in-person visit

Neurofeedback Session

Participants undergo either real or sham-control neurofeedback during eating

1 hour

1 in-person visit

Follow-up

Participants complete behavioral tasks and online questionnaires before and after the neurofeedback session, including a remote follow-up assessment

2 weeks

Remote follow-up assessment

Treatment Details

Interventions

• Real fNIRS Neurofeedback
• Sham-Control fNIRS Neurofeedback

Trial Overview The trial is testing neurofeedback using a brain imaging device called fNIRS while participants eat. It aims to see if this can help improve self-control over eating and reduce bulimia symptoms. Participants will receive either real neurofeedback or sham (fake) feedback as a comparison.

Participant Groups

Group I: Real fNIRS Neurofeedback Arm Experimental Treatment 1 Intervention

Participants assigned to the experimental arm will see their true, real-time brain activation (i.e., active real-time neurofeedback) during the neurofeedback session. This activation will be displayed to the participant as a thermometer that will increase as brain activation in the target region increases.

Group II: Sham-Control fNIRS Neurofeedback Arm Placebo Group 1 Intervention

Participants assigned to the sham-control arm will see false feedback (or a fake signal) that is not connected to their right vlPFC activation during the neurofeedback session.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

Functional near-infrared spectroscopy-based neurofeedback (fNIRS-neurofeedback) has shown promise in modulating brain activation and behaviors, with evidence from 22 studies involving 441 participants, including both healthy individuals and patients with conditions like ADHD and autism.

Despite the potential of fNIRS-neurofeedback as a practical and cost-effective alternative to EEG and fMRI neurofeedback, the current body of research is heterogeneous and lacks large randomized controlled trials, indicating a need for improved study quality and reporting practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of Functional Near-Infrared Spectroscopy-Based Neurofeedback-A Systematic Review and Recommendations for Best Practice. Kohl, SH., Mehler, DMA., Lührs, M., et al.[2022]

This pilot study involving 39 adults with binge-eating disorder (BED) found that both food-specific and general EEG neurofeedback significantly reduced binge-eating episodes and overall eating disorder symptoms after 6 weeks of treatment, with effects lasting for 3 months.

Both neurofeedback approaches were effective in altering brain activity, specifically reducing beta and enhancing theta power, suggesting that EEG neurofeedback could be a promising treatment for BED, although further research with larger samples is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG Neurofeedback in the Treatment of Adults with Binge-Eating Disorder: a Randomized Controlled Pilot Study. Blume, M., Schmidt, R., Schmidt, J., et al.[2022]

Neurofeedback, which trains individuals to control their brain activity using real-time feedback, has shown promise in initial studies but has not yet been specifically evaluated for treating eating disorders.

The paper reviews existing treatments for eating disorders and discusses how neurofeedback technologies, such as EEG and fMRI, could potentially be applied as innovative therapeutic options in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of neurofeedback in the treatment of eating disorders: a review of the literature. Bartholdy, S., Musiat, P., Campbell, IC., et al.[2022]

The study demonstrated the feasibility of using real-time functional near-infrared spectroscopy (rtfNIRS) and electroencephalography (EEG) neurofeedback (NF) in treating binge-eating disorder (BED) with 72 participants over 8 weeks, showing good recruitment and adherence rates.

While binge-eating frequency improved by an average of 8 episodes post-treatment, there was no significant difference between the NF groups and the waitlist control, although NF showed benefits in reducing food cravings, anxiety symptoms, and body mass index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-infrared spectroscopy and electroencephalography neurofeedback for binge-eating disorder: an exploratory randomized trial. Hilbert, A., Rösch, SA., Petroff, D., et al.[2023]

In a study involving 23 adults with binge-eating disorder (BED), specific mental strategies like 'Imagination,' 'Behavior,' and 'Thought' were found to positively influence the success of neurofeedback (NF) treatment aimed at reducing problematic brain activity.

The research identified a classification system for mental strategies that can help in regulating food-related responses, suggesting that certain strategies may be more effective than others in managing BED and could be useful beyond the NF treatment context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback strategies in binge-eating disorder as predictors of EEG-neurofeedback regulation success. Wimmer, J., Rösch, SA., Schmidt, R., et al.[2023]

In a study with 48 participants, it was found that individuals could successfully increase deoxygenated hemoglobin (deoxy-Hb) and decrease oxygenated hemoglobin (oxy-Hb) during neurofeedback sessions focused on swallowing imagery, indicating a trainable hemodynamic response.

The results suggest that real-time feedback using near-infrared spectroscopy (NIRS) can effectively reinforce the natural changes in hemoglobin levels during movement imagery, with improvements in the signal-to-noise ratio for deoxy-Hb, which could enhance the application of NIRS in neurofeedback training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trainability of hemodynamic parameters: A near-infrared spectroscopy based neurofeedback study. Kober, SE., Hinterleitner, V., Bauernfeind, G., et al.[2019]

In a study involving 27 female patients with eating disorders (ED) and 27 matched healthy controls, researchers found that the ED group exhibited significantly reduced frontal lobe activity during a cognitive task, indicating potential dysfunction in this brain region.

The study revealed that specific clinical symptoms of ED, such as dieting tendencies and eating behavior problems, are correlated with reduced activity in different areas of the frontal lobe, suggesting that these symptoms may be linked to distinct neural mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dieting tendency and eating behavior problems in eating disorder correlate with right frontotemporal and left orbitofrontal cortex: a near-infrared spectroscopy study. Suda, M., Uehara, T., Fukuda, M., et al.[2015]

Real-time fMRI neurofeedback has shown promise in treating psychiatric and behavioral disorders, but its application in eating disorders is still underexplored.

This paper outlines how to design and implement fMRI neurofeedback interventions specifically for anorexia nervosa, bulimia nervosa, and binge eating disorder, suggesting potential adaptations for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using real-time fMRI brain-computer interfacing to treat eating disorders. Sokunbi, MO.[2019]

The study involving six healthy male participants with overweight or mild obesity showed that 10 sessions of Near Infra-Red Hemoencephalography (N.I.R. H.E.G.) neurofeedback training led to increased self-control and inhibition related to food behavior, as well as reduced weight.

Participants exhibited increased brain activation in the superior orbitofrontal cortex during a response-inhibition task, suggesting that N.I.R. H.E.G. could be a promising tool for enhancing appetite control and addressing eating dysregulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of a novel therapeutic approach to obesity: CNS modification by N.I.R. H.E.G. neurofeedback. Percik, R., Cina, J., Even, B., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Potential of Functional Near-Infrared Spectroscopy-Based Neurofeedback-A Systematic Review and Recommendations for Best Practice. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

EEG Neurofeedback in the Treatment of Adults with Binge-Eating Disorder: a Randomized Controlled Pilot Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The potential of neurofeedback in the treatment of eating disorders: a review of the literature. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Near-infrared spectroscopy and electroencephalography neurofeedback for binge-eating disorder: an exploratory randomized trial. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Neurofeedback strategies in binge-eating disorder as predictors of EEG-neurofeedback regulation success. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Trainability of hemodynamic parameters: A near-infrared spectroscopy based neurofeedback study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Dieting tendency and eating behavior problems in eating disorder correlate with right frontotemporal and left orbitofrontal cortex: a near-infrared spectroscopy study. [2015]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Using real-time fMRI brain-computer interfacing to treat eating disorders. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A pilot study of a novel therapeutic approach to obesity: CNS modification by N.I.R. H.E.G. neurofeedback. [2020]