Recruiting

Neurofeedback

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05614024

Conditions

Bulimia Nervosa

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Real fNIRS Neurofeedback

Sham-Control fNIRS Neurofeedback

Study Details

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

Study ID

NCT05614024

Start date

May 13, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Real fNIRS Neurofeedback Arm

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.

sham comparator: Sham-Control fNIRS Neurofeedback Arm

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.

Interventions

Real fNIRS Neurofeedback

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.

Sham-Control fNIRS Neurofeedback

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.

Primary outcome measure

  • Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity [ Time Frame: approximately 1 hour ]
  • Go/no-go task performance [ Time Frame: 2 weeks ]
  • Number of loss-of-control eating and purging episodes [ Time Frame: 2 weeks ]
  • Severity of loss-of-control eating scale [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Sila Sozeri, B.A.

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

Laura A Berner, Ph.D.

laura.berner@mssm.edu

Locations

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

Recruiting

New York, New York, United States, 10027

Principal Investigator:

Laura A. Berner

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-01-30.