Craving Network Neurofeedback

Overweight or Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06426693
• Other study ID #: 2000037084
• Secondary ID: 1R01DK136623-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Kathleen A Garrison, PhD
• Phone: 2037376232
• Email: kathleen.garrison[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Ages 18 to 60 years

• Body mass index >25 kg/m2

• >2.37 Food Craving Inventory score

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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