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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real fNIRS Neurofeedback Arm | Experimental | 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. |
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| Sham-Control fNIRS Neurofeedback Arm | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real fNIRS Neurofeedback | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | approximately 1 hour |
| 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. | 2 weeks |
| 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. | 2 weeks |
| 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. | 2 weeks |
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Inclusion criteria:
Exclusion criteria:
The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of males and females.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sila Sozeri, B.A. | Contact | (212) 201-2679 | sila.sozeri@mssm.edu | |
| Laura A Berner, Ph.D. | Contact | laura.berner@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Laura A Berner, Ph.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10027 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Immediately following publication and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to laura.berner@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years after article publication via direct request to the investigator.
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| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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Participants will be assigned to one of two conditions, either the experimental or sham neurofeedback arm.
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| Sham-Control fNIRS Neurofeedback | Other | 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. |
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