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Functional MRI During Resting State in Patients with Eating Disorders

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06874348
Enrollment
50
Registered
2025-03-13
Start date
2024-10-24
Completion date
2026-10-31
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Bulimia Nervosa

Keywords

resting state fMRI, longitudinal evaluation

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.

Interventions

structural and functional MRI

Sponsors

Azienda Ospedaliero-Universitaria Careggi
CollaboratorOTHER
Meyer Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Eating Disorder Inventory (EDI) psychometric scoreBaseline - 12 months post-enrollment
Weight restorationbaseline - 12 months post-enrollment
Child Behavior Checklist (CBCL) scoreBaseline - 12 months post enrollment
Children's Depression Inventory (CDI) scorebaseline, 12 months post-enrollment
Multidimensional Anxiety Scale for Children (MASC)Baseline - 12 months post-enrollment
Change in cortical thicknessbaseline, 12 months post-enrollment

Secondary

MeasureTime frameDescription
Change in Regional Homogeneity (ReHo) indexbaseline, 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 databaseline, 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
Change of measure of interhemispheric connectivity between corresponding areas in fMRI (Voxelwise Homotopic Connectivity - VMHC)baseline, 12 months post-enrollmentVMHC 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.

Countries

Italy

Contacts

Primary ContactTiziana Pisano
t.pisano@meyer.it0039 055 5662907
Backup ContactGiovanni Castellini
giovanni.castellini@unifi.it0039 055 794 7478

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026