Neurofeedback During Eating for Bulimia Nervosa
ConditionBulimia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorIcahn School of Medicine at Mount Sinai
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
Aged 18 to 45 years
Meet diagnostic criteria for bulimia nervosa
Current body mass index greater than or equal to 18.5kg/m2 but under 30kg/m2
Disqualifiers
Ongoing medical treatment, major medical condition, or psychiatric disorder that may interfere with study variables or participation
Current psychotherapy focused primarily on eating disorder symptoms
Pregnancy or planned pregnancy, or lactation during the study period
Allergy to ingredients in the standardized meal or in the shake
Trial design
Design model
Parallel
Treatments tested in this trial
Real fNIRS Neurofeedback
Other interventionParticipants will be instructed to use real-time fNIRS neurofeedback to non-invasively regulate neural activation associated with symptoms in individuals with bulimia nervosa. During the training, participants will view images on a computer screen, listen to sounds, and consume a shake.
Sham-Control fNIRS Neurofeedback
Other interventionParticipants will be instructed to use sham real-time fNIRS neurofeedback to non-invasively regulate neural activation associated with symptoms in individuals with bulimia nervosa. During the training, participants will view images on a computer screen, listen to sounds, and consume a shake.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Real fNIRS Neurofeedback ArmExperimental treatment 1 intervention
Group B: Sham-Control fNIRS Neurofeedback ArmSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.
Time frame
approximately 1 hour2
Go/no-go task performance
Participants will complete a go/no-go task 1 week before and 1 week after the neurofeedback session to measure inhibitory control. Participants behavioral performance on the go/no-go task will be determined by the percentage of incorrect responses made as they are prompted to react to different pictorial stimuli. Participants' percentages of error can range from 0% to 100%. A higher percentage indicates a lower behavioral performance on the task.
Time frame
2 weeks3
Number of loss-of-control eating and purging episodes
Frequency of loss-of-control eating and purging episodes. Participants will self-report on how often loss-of-control eating and purging episodes occur using electronic daily diaries in the week before and the week after the neurofeedback session.
Time frame
2 weeks4
Severity of loss-of-control eating scale
Severity of loss-of-control eating. Participants will rate the severity of their feelings of control over eating and purging episodes on a Likert-type scale from 0-10. Higher score indicates greater severity of loss of control.
Time frame
2 weeksSponsors and contacts
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Source ClinicalTrials.gov