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Neurofeedback During Eating for Bulimia Nervosa

Primary Purpose

Bulimia Nervosa

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real fNIRS Neurofeedback
Sham-Control fNIRS Neurofeedback
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bulimia Nervosa

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria: Female Aged 18 to 35 years Meet diagnostic criteria for bulimia nervosa Currently between 85 and 130% of the expected weight for height 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

Sites / Locations

  • Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real fNIRS Neurofeedback Arm

Sham-Control fNIRS Neurofeedback Arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 4, 2022
Last Updated
October 17, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05614024
Brief Title
Neurofeedback During Eating for Bulimia Nervosa
Official Title
Neurofeedback During Eating: A Novel Mechanistic Treatment for Bulimia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to one of two conditions, either the experimental or sham neurofeedback arm.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real fNIRS Neurofeedback Arm
Arm Type
Experimental
Arm 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.
Arm Title
Sham-Control fNIRS Neurofeedback Arm
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Real fNIRS Neurofeedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham-Control fNIRS Neurofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
Description
The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.
Time Frame
approximately 1 hour
Title
Go/no-go task performance
Description
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.
Time Frame
2 weeks
Title
Number of loss-of-control eating and purging episodes
Description
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.
Time Frame
2 weeks
Title
Severity of loss-of-control eating scale
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of males and females.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Female Aged 18 to 35 years Meet diagnostic criteria for bulimia nervosa Currently between 85 and 130% of the expected weight for height 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Qiu, B.A.
Phone
212-201-2679
Email
jessica.qiu@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura A Berner, Ph.D.
Email
laura.berner@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Berner, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura A. Berner

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Immediately following publication and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to laura.berner@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years after article publication via direct request to the investigator.

Learn more about this trial

Neurofeedback During Eating for Bulimia Nervosa

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