Recruiting

Neurofeedback with fNIRS

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07581158

Conditions

Bulimia Nervosa

Feeding and Eating Disorders

Mental Disorders

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Real fNIRS Neurofeedback

Sham-Control fNIRS Neurofeedback

SmartPhone Intervention

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 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.

Conditions

Bulimia Nervosa

Feeding and Eating Disorders

Mental Disorders

Study ID

NCT07581158

Start date

Jun 17, 2026

Status verified date

Nov, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Female
  • Aged 18 to 55 years
  • Meet diagnostic criteria for bulimia nervosa (BN) or BN of low frequency and/or limited duration
  • Current body mass index greater than or equal to 18.5kg/m2 but under 40kg/m2
  • English-speaking

Exclusion criteria:

  • Ongoing medical treatment or planned/recent change in 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 shake

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

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-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

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.

Primary outcome measure

  • Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity [ Time Frame: Approximately 6 weeks ]
  • Go/no-go task performance [ Time Frame: Baseline through study completion, including 1-month follow-up (around 20 weeks) ]
  • Loss-of-control eating and compensatory behavior frequencies [ Time Frame: Baseline through study completion, including 1-month follow-up (around 20 weeks) ]
  • Eating Loss of Control Severity Subscale Score [ Time Frame: Baseline through study completion, including 1-month follow-up (around 20 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

Nov 5, 2026

Last verified

Nov, 2026

Keywords

  • fNIRS
  • fNIRS neurofeedback
  • smartphone intervention
  • eating disorders
  • bulimia nervosa
  • bulimia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.