Neurofeedback During Eating for Bulimia Nervosa

NCT05614024 | Recruiting

• 1 other identifier: GCO 21-2078
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bulimia Nervosa

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Other: Real fNIRS Neurofeedback

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.

Other: Sham-Control fNIRS Neurofeedback

Interventions

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.

Real fNIRS Neurofeedback Arm

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.

Sham-Control fNIRS Neurofeedback Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai

New York, New York, 10027, United States

RECRUITING

MeSH Terms

Conditions

Bulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Laura A Berner, Ph.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sila Sozeri, B.A.

CONTACT

(212) 201-2679; sila.sozeri@mssm.edu

Laura A Berner, Ph.D.

CONTACT

laura.berner@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be assigned to one of two conditions, either the experimental or sham neurofeedback arm.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: May 13, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Immediately following publication and ending 5 years following article publication.
• Access Criteria: 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.

Locations

US (1)