Neurofeedback for Bulimia Nervosa
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to assist women with bulimia nervosa, a condition characterized by episodes of consuming large amounts of food followed by unhealthy attempts to eliminate the calories. The study uses neurofeedback, which displays real-time brain activity, to enhance self-control over eating habits. Participants will receive feedback on their brain activity during sessions with real fNIRS neurofeedback (a type of brain activity monitoring) and will follow up with a four-week text-messaging program. Women who regularly experience symptoms of bulimia nervosa might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments and contribute to advancing research in bulimia nervosa.
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 it excludes those with ongoing medical treatment or recent changes in treatment. It's best to discuss your specific situation with the trial coordinators.
What prior data suggests that this neurofeedback method is safe for women with bulimia nervosa?
Previous studies have safely used digital mental health tools, such as smartphone apps, for eating disorders, including bulimia nervosa. Research shows these apps can reduce binge eating and purging without major safety concerns. Specific safety data for fNIRS neurofeedback, a noninvasive method to monitor brain activity, is not available. However, its noninvasive nature generally suggests safety. The study is labeled "Not Applicable" for its phase, indicating the treatment has shown enough promise in earlier research to warrant further testing in humans. Overall, both methods appear well-tolerated, with no significant side effects reported in similar studies.12345
Why are researchers excited about this trial?
Researchers are excited about using real fNIRS neurofeedback for bulimia nervosa because it offers a novel approach compared to traditional therapies like cognitive-behavioral therapy or medication. Unlike standard treatments that work through behavioral or chemical means, this method provides real-time feedback of brain activity, allowing participants to visualize and potentially regulate their own brain function. This unique technique may empower individuals to develop better self-control over their urges by directly influencing prefrontal cortex activation, which is crucial for decision-making and impulse control. Additionally, combining neurofeedback with a smartphone intervention offers continuous support, potentially enhancing the long-term effectiveness of the treatment.
What evidence suggests that this trial's treatments could be effective for bulimia nervosa?
Research has shown that neurofeedback, which involves displaying real-time brain activity to help individuals control it, can enhance self-control in those with eating disorders. One study found that using a brain imaging method called functional near-infrared spectroscopy (fNIRS) during neurofeedback sessions boosted activity in brain areas associated with self-regulation. This trial will compare two approaches: participants in one arm will receive Real fNIRS Neurofeedback, displaying true, real-time brain activation, while participants in another arm will receive Sham-Control fNIRS Neurofeedback, displaying false feedback. Both groups will also participate in a SmartPhone Intervention. These findings suggest that fNIRS neurofeedback might help manage bulimia by enhancing brain activity related to self-control.678910
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 18-55 who have bulimia nervosa or a similar eating disorder, with a BMI between 18.5 and 40. Participants must speak English.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neurofeedback Training
Participants undergo six in-person neurofeedback training sessions using fNIRS to evaluate PFC function
Text Messaging Intervention
Participants receive a 4-week text-messaging intervention to use neurofeedback strategies in daily life
Follow-up
Participants are monitored for safety and effectiveness after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Real fNIRS Neurofeedback
- Sham-Control fNIRS Neurofeedback
- SmartPhone Intervention
Trial Overview
The study tests two types of brain-based neurofeedback (real vs sham) using wearable imaging during eating, along with a four-week text message program, to see if these help control binge-eating behaviors in women with bulimia nervosa.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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. During the 4 week text-messaging intervention after neurofeedback, the active real-time neurofeedback group will be prompted to use neurofeedback strategies that increased their real PFC activation. Participants will also be directed to use these strategies in response to any unexpected urges each day.
Participants assigned to the sham-control arm will see false feedback (or a fake signal) during the neurofeedback session. During the 4 week text-messaging intervention after neurofeedback, the sham neurofeedback group will be prompted to use neurofeedback strategies they reported using when the sham feedback they saw was highest. Participants will also be directed to use these strategies in response to any unexpected urges each day.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Citations
Understanding and Targeting Self-Regulatory Control in ...
The purpose of this study is to examine the effects of PFC neurofeedback during eating in women with bulimia nervosa (BN) using fNIRS and a 4- ...
Neurofeedback during Eating: A Potential Novel and ...
We will compare the effects of one session of real and sham neurofeedback during eating ... BN, bulimia nervosa; fNIRS, functional near ...
Neurofeedback for Binge‐Eating Disorder - PMC
Pretreatment EEG and fNIRS activity predicted outcomes of neurofeedback for binge‐eating disorder with a larger effect size than rapid response, the ...
Neurofeedback for Bulimia
For instance, these studies indicate that fNIRS neurofeedback can boost activity in brain areas linked to self-control and learning without major side effects.
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)
REAL Definition & Meaning
1 ... a ... having objective independent existence ... unable to believe that what he saw was real ... b ... not artificial, fraudulent, or illusory : ...
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