Neurofeedback During Eating for Bulimia Nervosa

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05614024
Collaborator
(none)
30
1
2
23
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Real fNIRS Neurofeedback
  • Other: Sham-Control fNIRS Neurofeedback
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be assigned to one of two conditions, either the experimental or sham neurofeedback arm.Participants will be assigned to one of two conditions, either the experimental or sham neurofeedback arm.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Neurofeedback During Eating: A Novel Mechanistic Treatment for Bulimia Nervosa
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Real fNIRS Neurofeedback Arm

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.

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.

Sham Comparator: Sham-Control fNIRS Neurofeedback Arm

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity [approximately 1 hour]

    The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.

  2. Go/no-go task performance [2 weeks]

    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.

  3. Number of loss-of-control eating and purging episodes [2 weeks]

    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.

  4. Severity of loss-of-control eating scale [2 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai New York New York United States 10027

Sponsors and Collaborators

  • Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Laura A Berner, Ph.D., Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laura Berner, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT05614024
Other Study ID Numbers:
  • GCO 21-2078
First Posted:
Nov 14, 2022
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023