Bulimia Nervosa
Conditions
Brief summary
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.
Detailed description
The purpose of this study is to examine the effects of PFC neurofeedback during eating in women with bulimia nervosa (BN) using fNIRS. Specifically, the study aims 1) to demonstrate ventrolateral PFC (vlPFC) neurofeedback target engagement in women with BN using fNIRS; and 2) to link changes in PFC activation to changes in inhibitory control and eating-related symptoms. Data will be collected from women with BN who will be randomly assigned to one of two group conditions (real or sham-control neurofeedback during eating). Participation includes a phone screening assessment, psychodiagnostic assessment, one in-person evaluation, one neurofeedback session, behavioral tasks, online questionnaires before and after the neurofeedback session, and a remote follow-up assessment.
Interventions
Participants 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.
Participants 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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will be assigned to one of two conditions, either the experimental or sham neurofeedback arm.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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 * English-speaking
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity | approximately 1 hour | The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback. |
| Go/no-go task performance | 2 weeks | 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. |
| Number of loss-of-control eating and purging episodes | 2 weeks | 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. |
| Severity of loss-of-control eating scale | 2 weeks | 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. |
Countries
United States
Contacts
CONTACTSila Sozeri, B.A.
CONTACTLaura A Berner, Ph.D.
PRINCIPAL_INVESTIGATORLaura A Berner, Ph.D.
Icahn School of Medicine at Mount Sinai
Outcome results
None listed