Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
Key facts
- Who runs it
- Icahn School of Medicine at Mount Sinai
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 17 Jun 2026
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Real fNIRS Neurofeedback
- Sham-Control fNIRS Neurofeedback
- SmartPhone Intervention
- Record updated
- 5 November 2026
Who can take part
- Age
- 18 years to 55 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Allergy to ingredients in the shake
- Pregnancy or planned pregnancy, or lactation during the study period
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Where in United States
- Center for Computational Psychiatry at the Icahn School of Medicine at Mount SinaiNew York, United StatesContact: Laura A. Berner (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Real fNIRS Neurofeedback and SmartPhone Intervention ArmTreatment being tested
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.
Treatment: Real fNIRS Neurofeedback and SmartPhone Intervention
- Sham-Control fNIRS Neurofeedback and SmartPhone Intervention ArmSham treatment, for comparison
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.
Treatment: Sham-Control fNIRS Neurofeedback and SmartPhone Intervention
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa Via a Combined Real-Time Neurofeedback and Smartphone Intervention
- Fit questions
- Built from NCT07581158, who can take part
- Record updated
- 5 November 2026