Bulimia NervosaNCT05614024
Neurofeedback During Eating for Bulimia Nervosa
A study testing Real fNIRS Neurofeedback in people with Bulimia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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 a wearable brain imaging device, functional near-infrared spectroscopy (fNIRS). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- Real fNIRS Neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2024to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Laura A Berner, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
New York, New York, 10027
Laura A. Berner
About this study
Official title: Neurofeedback During Eating: A Novel Mechanistic Treatment for Bulimia Nervosa
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.
Read the detailed 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.
- Conditions
- Bulimia Nervosa
- Being tested
- Real fNIRS Neurofeedback, Sham-Control fNIRS Neurofeedback
- Medical subject headings
- Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real fNIRS NeurofeedbackOther
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 NeurofeedbackOther
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 group | Role | What they receive |
|---|---|---|
| Real fNIRS Neurofeedback Arm | Experimental | 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. Receives: Other: Real fNIRS Neurofeedback |
| Sham-Control fNIRS Neurofeedback Arm | Sham comparator | 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. Receives: Other: Sham-Control fNIRS Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.
Measured: approximately 1 hour
Go/no-go task performance
Participants will complete a go/no-go task 1 week before and 1 week after the neurofeedback session to measure inhibitory control.
Participants behavioral performance on the go/no-go task will be determined by the percentage of incorrect responses made as they are prompted to react to different pictorial stimuli. Participants' percentages of error can range from 0% to 100%. A higher percentage indicates a lower behavioral performance on the task.
Measured: 2 weeks
Number of loss-of-control eating and purging episodes
Frequency of loss-of-control eating and purging episodes. Participants will self-report on how often loss-of-control eating and purging episodes occur using electronic daily diaries in the week before and the week after the neurofeedback session.
Measured: 2 weeks
Severity of loss-of-control eating scale
Severity of loss-of-control eating. Participants will rate the severity of their feelings of control over eating and purging episodes on a Likert-type scale from 0-10. Higher score indicates greater severity of loss of control.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start13 May 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two conditions, either the experimental or sham neurofeedback arm.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Berner, Icahn School of Medicine at Mount Sinai
- Investigators
- Laura A Berner, Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614024
- Sponsor's protocol ID
- GCO 21-2078
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2022
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).