Craving Network Neurofeedback
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental feedback, Control feedback.
- Who it may be relevant to
- Registry conditions: Overweight or Obesity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Connectome-based Neurofeedback of the Craving Network to Reduce Food Cue Reactivity
Overview
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.
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.
Interventions
- 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). - 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).
Primary outcome measures
- Change in craving network strength during transfer runs [Time frame: Week 1 and 3]
- Change in Food Craving Inventory Mean Score [Time frame: Week 1, Week 7]
- Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI). [Time frame: Week 1, Week 7]
- Change in craving network strength during resting state runs [Time frame: Week 1 and 3]
- Change in Food Rating Task healthiness, tastiness, and choice scores [Time frame: Week 1, Week 7]
- Change in Food Snack Task caloric intake [Time frame: Week 1 and 3]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Yale MRRC Anlyan Center — New Haven
Identifiers
NCT: NCT06426693 · 2000037084 · 1R01DK136623-01A1