Recruiting

Neurofeedback

Sponsor:

Yale University

Code:

NCT06426693

Conditions

Overweight or Obesity

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Experimental feedback

Control feedback

Study Details

Brief 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.

Conditions

Overweight or Obesity

Study ID

NCT06426693

Start date

Nov 27, 2024

Status verified date

Dec, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neurofeedback

Three imaging (fMRI) sessions of experimental feedback.

sham comparator: Control neurofeedback

Three imaging (fMRI) sessions of sham feedback.

Interventions

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).

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kathleen A Garrison, PhD

2037376232kathleen.garrison@yale.edu

Locations

Yale MRRC Anlyan Center

Recruiting

New Haven, Connecticut, United States, 06519

More Information

Sponsor

Yale University

Last update posted

Dec 3, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-12-03.