Functional MRI During Resting State in Patients with Eating Disorders

March 11, 2025 updated by: Meyer Children's Hospital IRCCS

Functional MRI During Resting State in Patients with Eating Disorders: a Longitudinal Prospective Study on Neuropsychopathological Correlates

The goal of this observational study is to learn if clinical and neurophysiological characteristics dynamics may follow similar trends in a longitudinal characterization of patients with a diagnosis of an eating disorder.

The primary hypothesis is that the reversal of Functional Magnetic Resonance Imaging (fMRI) baseline alternations is positively associated with symptomatic amelioration.

The secondary hypothesis is that the degree of (f)MRI baseline alternations is positively associated with symptoms.

Participants will be asked to complete psychometric questionnaires, perform a fMRI and be recalled at 12 months for a follow-up.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Florence, Italy
        • Recruiting
        • Meyer Children's Hospital IRCCS
        • Contact:
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Careggi, Firenze
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Anorexia Nervosa or Bulimia Nervosa patients between 12 and 40 years old

Description

Inclusion Criteria:

  • Female sex
  • Age between 12 and 40 years old
  • Current diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR.

Exclusion Criteria:

  • Previous or current diagnosis of schizophrenia or bipolar disorder,
  • Acute psychosis
  • Substance abuse
  • Severe medical comorbidities (hypercapnia, severe hypertension, cardiac arrhythmia, organ failure)
  • incapacity to grant written or verbal consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anorexia Nervosa - minors
Diagnostic test: structural and functional MRI
structural and functional MRI
Bulimia Nervosa - minors
Diagnostic test: structural and functional MRI
structural and functional MRI
Anorexia Nervosa - adults
Diagnostic test: structural and functional MRI
structural and functional MRI
Bulimia Nervosa - adults
Diagnostic test: structural and functional MRI
structural and functional MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cortical thickness
Time Frame: baseline, 12 months post-enrollment
baseline, 12 months post-enrollment
Weight restoration
Time Frame: baseline - 12 months post-enrollment
baseline - 12 months post-enrollment
Child Behavior Checklist (CBCL) score
Time Frame: Baseline - 12 months post enrollment
Baseline - 12 months post enrollment
Children's Depression Inventory (CDI) score
Time Frame: baseline, 12 months post-enrollment
baseline, 12 months post-enrollment
Multidimensional Anxiety Scale for Children (MASC)
Time Frame: Baseline - 12 months post-enrollment
Baseline - 12 months post-enrollment
Eating Disorder Inventory (EDI) psychometric score
Time Frame: Baseline - 12 months post-enrollment
Baseline - 12 months post-enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of measure of interhemispheric connectivity between corresponding areas in fMRI (Voxelwise Homotopic Connectivity - VMHC)
Time Frame: baseline, 12 months post-enrollment
VMHC is a measure of interhemispheric connectivity between corresponding areas in fMRI. VMHC measures the level of symmetry, or correlation, between left/right pairs of voxels or brain areas.
baseline, 12 months post-enrollment
Change in Regional Homogeneity (ReHo) index
Time Frame: baseline, 12 months post-enrollment
baseline, 12 months post-enrollment
Chiange in amplitude of low-frequency fluctuations (ALFF) and fractional amplitude of low-frequency fluctuations (fALFF) of the blood oxygen-level dependent (BOLD) signal in fMRI data
Time Frame: baseline, 12 months post-enrollment
baseline, 12 months post-enrollment
Change in connection degree between each node and other nodes (Degree of Centrality - DC) in the network in the brain.
Time Frame: Baseline - 12 months post-enrollment
Baseline - 12 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Collaborators

Azienda Ospedaliero-Universitaria Careggi, Firenze

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS-FMRI-ED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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