Trials / Recruiting
RecruitingNCT05614024
Neurofeedback During Eating for Bulimia Nervosa
Neurofeedback During Eating: A Novel Mechanistic Treatment for Bulimia Nervosa
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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). The investigators will examine how this training may influence inhibitory control and BN symptoms.
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
| OTHER | Sham-Control fNIRS Neurofeedback | 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. |
Timeline
- Start date
- 2024-05-13
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2022-11-14
- Last updated
- 2026-01-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05614024. Inclusion in this directory is not an endorsement.