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Behavioural Intervention
Neurofeedback for Bulimia
N/A
Recruiting
Led By Laura A Berner, Ph.D.
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Study Summary
This trial studies how a brain imaging device can help reduce bulimia symptoms by training the brain to better control eating behavior.
Who is the study for?
This trial is for women aged 18 to 35 who have been diagnosed with bulimia nervosa and are within a certain weight range for their height. They must speak English but cannot be pregnant, planning pregnancy, or breastfeeding during the study. Those with allergies to meal ingredients, in specific psychotherapy, or with major medical conditions that could affect the study can't participate.Check my eligibility
What is being tested?
The trial is testing neurofeedback using a brain imaging device called fNIRS while participants eat. It aims to see if this can help improve self-control over eating and reduce bulimia symptoms. Participants will receive either real neurofeedback or sham (fake) feedback as a comparison.See study design
What are the potential side effects?
Since the intervention involves noninvasive brain imaging and feedback without medications, significant side effects are not expected. However, some may experience discomfort from wearing the fNIRS device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
Go/no-go task performance
Number of loss-of-control eating and purging episodes
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Real fNIRS Neurofeedback ArmExperimental Treatment1 Intervention
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.
Group II: Sham-Control fNIRS Neurofeedback ArmPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,446 Total Patients Enrolled
4 Trials studying Bulimia
501 Patients Enrolled for Bulimia
Laura A Berner, Ph.D.Principal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Bulimia
150 Patients Enrolled for Bulimia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am female.I am between 18 and 35 years old.I have been diagnosed with bulimia nervosa.I am currently in psychotherapy for an eating disorder.I don't have any health or mental conditions that could affect my study participation.
Research Study Groups:
This trial has the following groups:- Group 1: Real fNIRS Neurofeedback Arm
- Group 2: Sham-Control fNIRS Neurofeedback Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research encompass participants over the age of 18?
"This clinical trial is specifically designed for individuals aged 18 to 35. However, there are 11 other trials available for minors and 23 alternatives accessible to the elderly demographic."
Answered by AI
Has recruitment for this research trial commenced?
"According to the latest information posted on clinicaltrials.gov, this medical trial is no longer looking for additional patients. While it was originally shared with the public on November 1st 2022 and last updated a few days later, 45 other trials are still recruiting right now."
Answered by AI
Who meets the criteria for participation in this research endeavor?
"Eligibility for this trial necessitates that an individual has bulimia nervosa and is between 18 to 35 years old. In total, 30 patients will be enrolled in the study."
Answered by AI
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