Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
New York, 10027, United States
Location status: Recruiting
Location contact
Laura A. Berner
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT05614024
Neurofeedback During Eating for Bulimia Nervosa
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Real fNIRS Neurofeedback
OtherParticipants 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
OtherParticipants 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.
Primary outcomes
-
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
Time frame: approximately 1 hour
The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.
-
Go/no-go task performance
Time frame: 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
Time frame: 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
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Laura A Berner, Ph.D.
CONTACT
Sila Sozeri, B.A.
CONTACT
Sponsors and collaborators
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Registry information
Official study title
Neurofeedback During Eating: A Novel Mechanistic Treatment for Bulimia Nervosa
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Nov 14, 2022
- Registry last updated
- Jan 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
Eating Disorder Dynamic Intervention
NCT07600671
Anorexia Nervosa, Binge Eating Disorder
Lebanon, New Hampshire, United States
View Trial Details
Recruiting
Eating Disorders Genetics Initiative 2
NCT06594913
Anorexia Nervosa, Avoidant Restrictive Food Intake Disorder
Chapel Hill, North Carolina, United States
View Trial Details
Recruiting
MDMA Assisted Therapy for BN
NCT07542145
Bulimia, Bulimia Nervosa
New York, United States
View Trial Details
Recruiting
Targeting Social Function in Anxiety and Eating Disorders
NCT06198023
Anorexia Nervosa, Anxiety Disorders
Dallas, Texas, United States
View Trial Details