Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa

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

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07581158
Status
Not Yet Recruiting

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Conditions

  • Bulimia Nervosa
  • Feeding and Eating Disorders
  • Mental Disorders

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 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-control 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.
  • SmartPhone Intervention — OTHER
    Over the subsequent 4 weeks, at the specific times when each individual is most likely to engage in eating disorder symptoms, participants will receive personalized messages to use mental strategies from their real-time or their sham-control fNIRS neurofeedback.

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 wearable brain imaging, functional near-infrared spectroscopy (fNIRS), together with a brain-based 4-week text-messaging intervention. The investigators will examine how these interventions may influence inhibitory control and eating disorder symptoms in women with bulimia nervosa.

Key Dates

Start date
Apr 25, 2026
Status verified
May 2026
Primary completion
Dec 14, 2028
Completion
Dec 14, 2028

Study Design

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

Arms

  • Experimental: Real fNIRS Neurofeedback and SmartPhone Intervention 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. During the 4 week text-messaging intervention after neurofeedback, the active real-time neurofeedback group will be prompted to use neurofeedback strategies that increased their real PFC activation. Participants will also be directed to use these strategies in response to any unexpected urges each day.
  • Sham Comparator: Sham-Control fNIRS Neurofeedback and SmartPhone Intervention Arm
    Participants assigned to the sham-control arm will see false feedback (or a fake signal) during the neurofeedback session. During the 4 week text-messaging intervention after neurofeedback, the sham neurofeedback group will be prompted to use neurofeedback strategies they reported using when the sham feedback they saw was highest. Participants will also be directed to use these strategies in response to any unexpected urges each day.

Primary Outcome Measure

Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity [ Time Frame: Approximately 6 weeks ]

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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