Neurofeedback During Eating for Bulimia Nervosa

Mount Sinai Health System

Status: Enrolling

Conditions: Bulimia Nervosa

Treatments: Other: Sham-Control fNIRS Neurofeedback; Other: Real fNIRS Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05614024

GCO 21-2078

Details and patient eligibility

About

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.

Full description

The purpose of this study is to examine the effects of PFC neurofeedback during eating in women with bulimia nervosa (BN) using fNIRS. Specifically, the study aims 1) to demonstrate ventrolateral PFC (vlPFC) neurofeedback target engagement in women with BN using fNIRS; and 2) to link changes in PFC activation to changes in inhibitory control and eating-related symptoms.

Data will be collected from women with BN who will be randomly assigned to one of two group conditions (real or sham-control neurofeedback during eating). Participation includes a phone screening assessment, psychodiagnostic assessment, one in-person evaluation, one neurofeedback session, behavioral tasks, online questionnaires before and after the neurofeedback session, and a remote follow-up assessment.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Real fNIRS Neurofeedback Arm

Experimental group

Description:

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.

Treatment:

Other: Real fNIRS Neurofeedback

Sham-Control fNIRS Neurofeedback Arm

Sham Comparator group

Description:

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.

Treatment:

Other: Sham-Control fNIRS Neurofeedback