Neurofeedback During Eating for Bulimia Nervosa

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05614024
Status
Recruiting
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Conditions

  • Bulimia Nervosa

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 13, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity [ Time Frame: approximately 1 hour ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Computational Psychiatry at the Icahn School of Medicine at Mount SinaiNew YorkNew York10027
Laura A. Berner (PRINCIPAL_INVESTIGATOR)

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By research site
Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai· New York, NY

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