Functional MRI During Resting State in Patients with Eating Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age12-40
SponsorMeyer Children's Hospital IRCCS
About this trial
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
This trial does not accept healthy volunteersQualifiers
Female sex
Age between 12 and 40 years old
Current diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR.
Disqualifiers
Previous or current diagnosis of schizophrenia or bipolar disorder,
Acute psychosis
Substance abuse
Severe medical comorbidities (hypercapnia, severe hypertension, cardiac arrhythmia, organ failure)
Trial population
Anorexia Nervosa or Bulimia Nervosa patients between 12 and 40 years old
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
structural and functional MRI
Diagnostic teststructural and functional MRI
Treatment groups
50 Participants
are divided into 4 treatment groupsGroup A: Anorexia Nervosa - minors1 intervention
Group B: Bulimia Nervosa - minors1 intervention
Group C: Anorexia Nervosa - adults1 intervention
Group D: Bulimia Nervosa - adults1 intervention
Trial outcomes
Primary outcomes
1
Change in cortical thickness
Time frame
baseline, 12 months post-enrollment2
Weight restoration
Time frame
baseline - 12 months post-enrollment3
Child Behavior Checklist (CBCL) score
Time frame
Baseline - 12 months post enrollment4
Children's Depression Inventory (CDI) score
Time frame
baseline, 12 months post-enrollmentSecondary outcomes
1
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.
Time frame
baseline, 12 months post-enrollment2
Change in Regional Homogeneity (ReHo) index
Time frame
baseline, 12 months post-enrollment3
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-enrollment4
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-enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Meyer Children's Hospital IRCCS
Lead sponsor
Azienda Ospedaliero-Universitaria Careggi
Collaborator
Source ClinicalTrials.gov