Neurofeedback During Eating for Bulimia Nervosa

Bulimia Nervosa Clinical Trial

Official title:

Neurofeedback During Eating: A Novel Mechanistic Treatment for Bulimia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614024
• Other study ID #: GCO 21-2078
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Jessica Qiu, B.A.
• Phone: 212-201-2679
• Email: jessica.qiu[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). The investigators will examine how this training may influence inhibitory control and BN symptoms.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

• 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

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

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa

Intervention

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-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.

Locations

Country	Name	City	State
United States	Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 1 hour
Primary	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.	2 weeks
Primary	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.	2 weeks
Primary	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.	2 weeks