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| Name | Class |
|---|---|
| Azienda Ospedaliero-Universitaria Careggi | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anorexia Nervosa - minors |
| ||
| Bulimia Nervosa - minors |
| ||
| Anorexia Nervosa - adults |
| ||
| Bulimia Nervosa - adults |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| structural and functional MRI | Diagnostic Test | structural and functional MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of measure of interhemispheric connectivity between corresponding areas in fMRI (Voxelwise Homotopic Connectivity - VMHC) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Anorexia Nervosa or Bulimia Nervosa patients between 12 and 40 years old
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiziana Pisano | Contact | 0039 055 5662907 | t.pisano@meyer.it | |
| Giovanni Castellini | Contact | 0039 055 794 7478 | giovanni.castellini@unifi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Careggi, Firenze | Recruiting | Florence | Italy |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D052018 | Bulimia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |
| Meyer Children's Hospital IRCCS | Recruiting | Florence | Italy |
|