Functional MRI During Resting State in Patients with Eating Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: structural and functional MRI.
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa, Bulimia Nervosa. Basic parameters: 12 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Functional MRI During Resting State in Patients with Eating Disorders: a Longitudinal Prospective Study on Neuropsychopathological Correlates
Overview
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
- Diagnostic test structural and functional MRI
structural and functional MRI
Primary outcome measures
- Change in cortical thickness [Time frame: baseline, 12 months post-enrollment]
- Weight restoration [Time frame: baseline - 12 months post-enrollment]
- Child Behavior Checklist (CBCL) score [Time frame: Baseline - 12 months post enrollment]
- Children's Depression Inventory (CDI) score [Time frame: baseline, 12 months post-enrollment]
- Multidimensional Anxiety Scale for Children (MASC) [Time frame: Baseline - 12 months post-enrollment]
- Eating Disorder Inventory (EDI) psychometric score [Time frame: Baseline - 12 months post-enrollment]
Secondary outcome measures (4)
- Change of measure of interhemispheric connectivity between corresponding areas in fMRI (Voxelwise Homotopic Connectivity - VMHC) [Time frame: baseline, 12 months post-enrollment]
- Change in Regional Homogeneity (ReHo) index [Time frame: 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 2 centers
- Azienda Ospedaliero-Universitaria Careggi, Firenze — Florence
- Meyer Children's Hospital IRCCS — Florence
Identifiers
NCT: NCT06874348 · RS-FMRI-ED