Neurofeedback for Bulimia
Recruiting in Palo Alto (17 mi)
Overseen byLaura A Berner, Ph.D.
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Disqualifiers: Major medical condition, Psychiatric disorder, Pregnancy, others
No Placebo Group
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.
12345Is 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.
14567How 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.
34589Eligibility 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.
+2 more
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.
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Real fNIRS Neurofeedback ArmExperimental Treatment1 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 ArmPlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Center for Computational Psychiatry at the Icahn School of Medicine at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
References
The Potential of Functional Near-Infrared Spectroscopy-Based Neurofeedback-A Systematic Review and Recommendations for Best Practice. [2022]Background: The effects of electroencephalography (EEG) and functional magnetic resonance imaging (fMRI)-neurofeedback on brain activation and behaviors have been studied extensively in the past. More recently, researchers have begun to investigate the effects of functional near-infrared spectroscopy-based neurofeedback (fNIRS-neurofeedback). FNIRS is a functional neuroimaging technique based on brain hemodynamics, which is easy to use, portable, inexpensive, and has reduced sensitivity to movement artifacts. Method: We provide the first systematic review and database of fNIRS-neurofeedback studies, synthesizing findings from 22 peer-reviewed studies (including a total of N = 441 participants; 337 healthy, 104 patients). We (1) give a comprehensive overview of how fNIRS-neurofeedback training protocols were implemented, (2) review the online signal-processing methods used, (3) evaluate the quality of studies using pre-set methodological and reporting quality criteria and also present statistical sensitivity/power analyses, (4) investigate the effectiveness of fNIRS-neurofeedback in modulating brain activation, and (5) review its effectiveness in changing behavior in healthy and pathological populations. Results and discussion: (1-2) Published studies are heterogeneous (e.g., neurofeedback targets, investigated populations, applied training protocols, and methods). (3) Large randomized controlled trials are still lacking. In view of the novelty of the field, the quality of the published studies is moderate. We identified room for improvement in reporting important information and statistical power to detect realistic effects. (4) Several studies show that people can regulate hemodynamic signals from cortical brain regions with fNIRS-neurofeedback and (5) these studies indicate the feasibility of modulating motor control and prefrontal brain functioning in healthy participants and ameliorating symptoms in clinical populations (stroke, ADHD, autism, and social anxiety). However, valid conclusions about specificity or potential clinical utility are premature. Conclusion: Due to the advantages of practicability and relatively low cost, fNIRS-neurofeedback might provide a suitable and powerful alternative to EEG and fMRI neurofeedback and has great potential for clinical translation of neurofeedback. Together with more rigorous research and reporting practices, further methodological improvements may lead to a more solid understanding of fNIRS-neurofeedback. Future research will benefit from exploiting the advantages of fNIRS, which offers unique opportunities for neurofeedback research.
EEG Neurofeedback in the Treatment of Adults with Binge-Eating Disorder: a Randomized Controlled Pilot Study. [2022]Specific alterations in electroencephalography (EEG)-based brain activity have recently been linked to binge-eating disorder (BED), generating interest in treatment options targeting these neuronal processes. This randomized-controlled pilot study examined the effectiveness and feasibility of two EEG neurofeedback paradigms in the reduction of binge eating, eating disorder and general psychopathology, executive functioning, and EEG activity. Adults with BED and overweight (N = 39) were randomly assigned to either a food-specific EEG neurofeedback paradigm, aiming at reducing fronto-central beta activity and enhancing theta activity after viewing highly palatable food pictures, or a general EEG neurofeedback paradigm training the regulation of slow cortical potentials. In both conditions, the study design included a waiting period of 6 weeks, followed by 6 weeks EEG neurofeedback (10 sessions à 30 min) and a 3-month follow-up period. Both EEG neurofeedback paradigms significantly reduced objective binge-eating episodes, global eating disorder psychopathology, and food craving. Approximately one third of participants achieved abstinence from objective binge-eating episodes after treatment without any differences between treatments. These results were stable at 3-month follow-up. Among six measured executive functions, only decision making improved at posttreatment in both paradigms, and cognitive flexibility was significantly improved after food-specific neurofeedback only. Both EEG neurofeedback paradigms were equally successful in reducing relative beta and enhancing relative theta power over fronto-central regions. The results highlight EEG neurofeedback as a promising treatment option for individuals with BED. Future studies in larger samples are needed to determine efficacy and treatment mechanisms.
The potential of neurofeedback in the treatment of eating disorders: a review of the literature. [2022]Neurofeedback is defined as the training of voluntary regulation of localised neural activity using real-time feedback through a brain-computer interface. It has shown initial success as a potential clinical treatment tool in proof of concept studies, but has yet to be evaluated with respect to eating disorders. This paper (i) provides a brief overview of the current status of eating disorder treatments; (ii) describes the studies to date that use neurofeedback involving electroencephalography, real-time functional magnetic resonance imaging or near-infrared spectroscopy; and (iii) considers the potential of these technologies as treatments for eating disorders.
Near-infrared spectroscopy and electroencephalography neurofeedback for binge-eating disorder: an exploratory randomized trial. [2023]Binge-eating disorder (BED) co-occurs with neurobehavioral alterations in the processing of disorder-relevant content such as visual food stimuli. Whether neurofeedback (NF) directly targeting them is suited for treatment remains unclear. This study sought to determine feasibility and estimate effects of individualized, functional near-infrared spectroscopy-based real-time NF (rtfNIRS-NF) and high-beta electroencephalography-based NF (EEG-NF), assuming superiority over waitlist (WL).
Neurofeedback strategies in binge-eating disorder as predictors of EEG-neurofeedback regulation success. [2023]Treatment options such as neurofeedback (NF) that directly target the link between aberrant brain activity patterns and dysfunctional eating behaviors in binge-eating disorder (BED) are emerging. However, virtually nothing is known about mental strategies used to modulate food-specific brain activity and the associated brain-based or subjective success of specific strategies. This study firstly investigated the use of mental strategies in response to individually appetitive food cues in adults with BED and overweight or obesity based on a randomized-controlled trial providing electroencephalography (EEG)- or real-time functional near-infrared spectroscopy (rtfNIRS)-NF to BED.
Trainability of hemodynamic parameters: A near-infrared spectroscopy based neurofeedback study. [2019]We investigated the trainability of the hemodynamic response as assessed with near-infrared spectroscopy (NIRS) during one neurofeedback (NF) session. Forty-eight participants were randomly assigned to four different groups that tried to either increase or decrease oxygenated (oxy-Hb) or deoxygenated hemoglobin (deoxy-Hb) over the inferior frontal gyrus during imagery of swallowing movements. Deoxy-Hb could be successfully up-regulated while oxy-Hb could be successfully down-regulated during NF. Participants were not able to down-regulate deoxy-Hb or to up-regulate oxy-Hb. These results show that the natural course of oxy- and deoxy-Hb during movement imagery can be reinforced by providing real-time feedback of the corresponding NIRS parameter since deoxy-Hb generally increases and oxy-Hb decreases during imagery of swallowing. Furthermore, signal-to-noise ratio of deoxy-Hb but not of oxy-Hb improved during training. Our results provide new insights into the trainability of the hemodynamic response as assessed with NIRS and have an impact on the application of NIRS-based real-time feedback.
Dieting tendency and eating behavior problems in eating disorder correlate with right frontotemporal and left orbitofrontal cortex: a near-infrared spectroscopy study. [2015]Frontal lobe dysfunctions have been implicated as one of the pathophysiological bases in eating disorder (ED). Neural substrates of ED have been examined in neuroimaging studies employing symptom-related stimuli, such as food and body-image distortion, but with inconsistent results because of differences in study design, task, and stimulus used. In order to elucidate frontal lobe dysfunction correlates of clinical symptoms in ED, we examined the frontal lobe function during a cognitive task, not a symptom-related task, using near-infrared spectroscopy (NIRS), which is suitable for the functional neuroimaging study of ED because of its complete noninvasiveness and natural measurement setting. Regional hemodynamic changes were monitored during a verbal fluency task (letter version) using a 52-channel NIRS apparatus in 27 female ED patients and 27 matched healthy controls, and their correlations with clinical symptoms assessed using the Eating Attitude Scale (EAT-26) were examined. Regional hemodynamic changes were significantly smaller in the ED group than in the control group in the bilateral orbitofrontal and right frontotemporal regions, and negatively correlated with dieting tendency scores in EAT-26 in the right frontotemporal regions and with the eating restriction and binge eating scores in the left orbitofrontal regions. The clinical symptoms of ED are considered to consist of two components: dieting tendency that correlates with the right frontotemporal cortex and eating behavior problems that correlate with left the orbitofrontal cortex.
Using real-time fMRI brain-computer interfacing to treat eating disorders. [2019]Real-time functional magnetic resonance imaging based brain-computer interfacing (fMRI neurofeedback) has shown encouraging outcomes in the treatment of psychiatric and behavioural disorders. However, its use in the treatment of eating disorders is very limited. Here, we give a brief overview of how to design and implement fMRI neurofeedback intervention for the treatment of eating disorders, considering the basic and essential components. We also attempt to develop potential adaptations of fMRI neurofeedback intervention for the treatment of anorexia nervosa, bulimia nervosa and binge eating disorder.
A pilot study of a novel therapeutic approach to obesity: CNS modification by N.I.R. H.E.G. neurofeedback. [2020]Despite the thorough mapping of brain pathways involved in eating behavior, no treatment aimed at modulating eating dysregulation from its neurocognitive root has been established yet. We aimed to evaluate the effect of N.I.R. H.E.G. (Near Infra-Red Hemoencephalography) neurofeedback training on appetite control, weight and food-related brain activity.