Clinical trial NCT06874348: Functional MRI During Resting State in Patients with Eating Disorders
Official title: Functional MRI During Resting State in Patients with Eating Disorders: a Longitudinal Prospective Study on Neuropsychopathological Correlates
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Bulimia Nervosa
Keywords: resting state fMRI
longitudinal evaluation
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria Careggi
First posted: 2025-03-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anorexia Nervosa or Bulimia Nervosa patients between 12 and 40 years old

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.


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

Primary outcomes:
measure: Change in cortical thickness
timeFrame: baseline, 12 months post-enrollment
measure: Weight restoration
timeFrame: baseline - 12 months post-enrollment
measure: Child Behavior Checklist (CBCL) score
timeFrame: Baseline - 12 months post enrollment
measure: Children's Depression Inventory (CDI) score
timeFrame: baseline, 12 months post-enrollment
measure: Multidimensional Anxiety Scale for Children (MASC)
timeFrame: Baseline - 12 months post-enrollment
measure: Eating Disorder Inventory (EDI) psychometric score
timeFrame: Baseline - 12 months post-enrollment
Secondary outcomes:
measure: Change of measure of interhemispheric connectivity between corresponding areas in fMRI (Voxelwise Homotopic Connectivity - VMHC)
timeFrame: baseline, 12 months post-enrollment
measure: Change in Regional Homogeneity (ReHo) index
timeFrame: baseline, 12 months post-enrollment
measure: 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
timeFrame: baseline, 12 months post-enrollment
measure: Change in connection degree between each node and other nodes (Degree of Centrality - DC) in the network in the brain.
timeFrame: Baseline - 12 months post-enrollment
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi, Firenze
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
Study officials:
References: