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NCT Number: NCT06426693

Craving Network Neurofeedback

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.

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Key information

Conditions

Overweight or Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale MRRC Anlyan Center

New Haven, Connecticut, 06519, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental feedback

Device

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).

Control feedback

Device

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).

Primary outcomes

  1. Change in craving network strength during transfer runs

    Time frame: Week 1 and 3

    Craving network strength will be measured during transfer (i.e., no feedback) runs and compared across scan sessions.

  2. Change in Food Craving Inventory Mean Score

    Time frame: Week 1, Week 7

    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.

  3. Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI).

    Time frame: Week 1, Week 7

    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.

  4. Change in craving network strength during resting state runs

    Time frame: Week 1 and 3

    Craving network strength will be measured during resting state runs and compared across scan sessions.

  5. Change in Food Rating Task healthiness, tastiness, and choice scores

    Time frame: Week 1, Week 7

    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.

  6. Change in Food Snack Task caloric intake

    Time frame: Week 1 and 3

    Food Snack Task will be used to measure caloric intake (out of a maximum value to calories offered) and compared across scan sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen A Garrison, PhD

CONTACT

[email protected]

2037376232

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 23, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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