Craving Network Neurofeedback

Connectome-based Neurofeedback of the Craving Network to Reduce Food Cue Reactivity

This project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues using neurofeedback, to impact their craving and eating behavior.

Study Overview

• Status: Recruiting
• Conditions: Overweight or Obesity
• Intervention / Treatment: Device: Experimental feedback; Device: Control feedback

Detailed Description

Aim 1 of this study is to test whether neurofeedback from the craving network is associated with reduced craving network strength.

Aim 2 of this study is to test whether neurofeedback from the craving network is associated with reduced food craving and changes in eating behavior.

Aim 3 of this study is to test whether neurofeedback from the craving network is associated with changes in resting state functional connectivity.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen A Garrison, PhD; Phone Number: 2037376232; Email: kathleen.garrison@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale MRRC Anlyan Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ages 18 to 60 years
• Body mass index >25 kg/m2
• >2.37 Food Craving Inventory score

Exclusion Criteria:

• Current or past 6 months use of anti-obesity medications
• Weight-reduced state defined as >10% weight reduction in the past 6 months.
• Nicotine use
• Current diagnosis of neurological or psychiatric disorder
• Obesity-related diseases such as type-2 diabetes
• Contraindications to MRI
• Baseline scanning with motion >0.15mm frame to frame displacement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurofeedback; Three imaging (fMRI) sessions of experimental feedback.	Device: Experimental feedback; Participants provided with feedback of target brain activation patterns (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer).
Sham Comparator: Control neurofeedback; Three imaging (fMRI) sessions of sham feedback.	Device: Control feedback; Participants provided with control (sham, yoked to another participant) feedback (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in craving network strength during transfer runs	Craving network strength will be measured during transfer (i.e., no feedback) runs and compared across scan sessions.	Week 1 and 3
Change in Food Craving Inventory Mean Score	Food Craving Inventory has 28 items rated 1-5 and overall mean is calculated, range 1-5 with higher score indicating higher craving. FCI will be compared between baseline and 1 month follow-up.	Week 1, Week 7
Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI).	ASA-24 HEI is scored 0-100 with 100 indicating healthier diet and composite scores examined to interpret the overall score. HEI will be compared between baseline and 1 month follow-up.	Week 1, Week 7
Change in craving network strength during resting state runs	Craving network strength will be measured during resting state runs and compared across scan sessions.	Week 1 and 3
Change in Food Rating Task healthiness, tastiness, and choice scores	Food Rating Task outcomes include healthiness, tastiness, and choice. Healthiness and tastiness mean score is taken, range 1-5, with 5 indicating higher healthiness or tastiness. Choice is counted from 0-48 items choosing the food item over the neutral reference food item, with higher values indicating more frequent choice. Food Ratings will be compared between baseline and 1 month follow-up.	Week 1, Week 7
Change in Food Snack Task caloric intake	Food Snack Task will be used to measure caloric intake (out of a maximum value to calories offered) and compared across scan sessions.	Week 1 and 3

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Kathleen A Garrison, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 2000037084; 1R01DK136623-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be findable for the research community through OpenNeuro and NITRC search functions.
• IPD Sharing Time Frame: The research community will have access to data when the award ends.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No