Functional MRI During Resting State in Patients with Eating Disorders

Recruiting

• Conditions: Anorexia Nervosa; Bulimia Nervosa

• Registration Number: NCT06874348
• Lead Sponsor: Meyer Children's Hospital IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-24
• Study First Submitted: 2025-02-27
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change of measure of interhemispheric connectivity between corresponding areas in fMRI (Voxelwise Homotopic Connectivity - VMHC)	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.
Change in Regional Homogeneity (ReHo) index	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	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.	Baseline - 12 months post-enrollment

Trial Locations

Locations (2)

Azienda Ospedaliero-Universitaria Careggi, Firenze; 🇮🇹 Florence, Italy

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Italy