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NCT Number: NCT06874348

Functional MRI During Resting State in Patients with Eating Disorders

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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Key information

Conditions

Anorexia Nervosa Bulimia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

12 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria Careggi, Firenze, Florence, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

structural and functional MRI

Diagnostic Test

structural and functional MRI

Primary outcomes

  1. Change in cortical thickness

    Time frame: baseline, 12 months post-enrollment

  2. Weight restoration

    Time frame: baseline - 12 months post-enrollment

  3. Child Behavior Checklist (CBCL) score

    Time frame: Baseline - 12 months post enrollment

  4. Children's Depression Inventory (CDI) score

    Time frame: baseline, 12 months post-enrollment

  5. Multidimensional Anxiety Scale for Children (MASC)

    Time frame: Baseline - 12 months post-enrollment

  6. Eating Disorder Inventory (EDI) psychometric score

    Time frame: Baseline - 12 months post-enrollment

Secondary outcomes

  1. Change of measure of interhemispheric connectivity between corresponding areas in fMRI (Voxelwise Homotopic Connectivity - VMHC)

    Time frame: baseline, 12 months post-enrollment

    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.

  2. Change in Regional Homogeneity (ReHo) index

    Time frame: baseline, 12 months post-enrollment

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Castellini

CONTACT

[email protected]

0039 055 794 7478

Tiziana Pisano

CONTACT

[email protected]

0039 055 5662907

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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