Craving Network Neurofeedback

NCT ID: NCT06426693

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-27

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Overweight or Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Neurofeedback

Three imaging (fMRI) sessions of experimental feedback.

Group Type EXPERIMENTAL

Experimental feedback

Intervention Type 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 neurofeedback

Three imaging (fMRI) sessions of sham feedback.

Group Type SHAM_COMPARATOR

Control feedback

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen A Garrison, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale MRRC Anlyan Center

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen A Garrison, PhD

Role: CONTACT

2037376232

Other Identifiers

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1R01DK136623-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000037084

Identifier Type: -

Identifier Source: org_study_id

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