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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special type of brain training, called real fNIRS neurofeedback, can help women with bulimia nervosa, a condition characterized by binge eating followed by unhealthy weight control methods. Participants will use a device that displays their brain activity in real-time, similar to a thermometer, which might help them better control their urges. The study will compare this real feedback to a sham-control fNIRS neurofeedback to determine which is more effective. Ideal candidates are English-speaking women aged 18-45 with bulimia and a body mass index between 18.5 and 30, without other major health issues. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could lead to new treatment options for bulimia nervosa.

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 prior data suggests that this neurofeedback technique is safe for bulimia treatment?

Research has shown that fNIRS neurofeedback is generally safe for people. This noninvasive method does not involve surgery or entering the body. Studies have found that various trials have used this technique without causing significant harm. For instance, these studies indicate that fNIRS neurofeedback can boost activity in brain areas linked to self-control and learning without major side effects. This suggests that the treatment is well-tolerated and doesn't pose serious risks in the short term. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the neurofeedback treatment for bulimia because it offers a novel approach by directly targeting brain activity. Unlike traditional treatments such as cognitive-behavioral therapy or medication, this method uses real-time fNIRS neurofeedback to help participants visualize and modify their brain activity. This process could empower individuals to gain better control over urges and behaviors associated with bulimia, potentially leading to more effective management of the condition. Additionally, the use of a sham-control group ensures that any observed effects are genuinely due to changes in brain activity, providing robust evidence for the method's effectiveness.

What evidence suggests that this neurofeedback method is effective for bulimia?

Research has shown that neurofeedback, which displays real-time brain activity to participants, holds promise for binge eating and other mental health issues. Early studies using EEG-based neurofeedback demonstrated somewhat positive effects for binge eating. Although more research is needed specifically for eating disorders, real-time fMRI neurofeedback has potential in treating related conditions. In this trial, participants will receive either Real fNIRS Neurofeedback, using functional near-infrared spectroscopy (fNIRS) to display true, real-time brain activation, or Sham-Control fNIRS Neurofeedback, which provides false feedback. These early findings suggest that neurofeedback could help improve symptoms of bulimia by enhancing self-control during eating. ^{1 2 3 5 6}

Who Is on the Research Team?

Laura A Berner, Ph.D.

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. jpbs.hapres.com jpbs.hapres.com/AddDownload.aspx?id=1664&type=pdf&action=JPBS

Neurofeedback during Eating: A Potential Novel and ... Initial studies have found somewhat promising effects of EEG-based neurofeedback for binge eating [25–27]. To our knowledge, only one other ...

2. withpower.com withpower.com/trial/phase-bulimia-10-2022-b899c

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

3. cambridge.org cambridge.org/core/journals/psychological-medicine/article/nearinfrared-spectroscopy-and-electroencephalography-neurofeedback-for-bingeeating-disorder-an-exploratory-randomized-trial/E69E86B3E657B283BAC0332144902403

Near-infrared spectroscopy and electroencephalography ... This study sought to determine feasibility and estimate effects of individualized, functional near-infrared spectroscopy-based real-time NF (rtfNIRS-NF)

4. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1234085/full

Neurofeedback strategies in binge-eating disorder as ... This study firstly investigated the use of mental strategies in response to individually appetitive food cues in adults with BED and overweight or obesity.

5. nature.com nature.com/articles/s41598-024-69863-w

Functional near-infrared spectroscopy-based ... Behavioural results revealed a significant effect of hunger and motivation on the participant control feeling and a lower control feeling when ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37871494/

Mechanisms underlying fNIRS-neurofeedback over the ... Results: Higher online regulation success expectedly predicted better subjective, but worse offline regulation success. LOC eating decreased after vs. before, ...