Anorexia NervosaNCT06874348
Functional MRI During Resting State in Patients with Eating Disorders
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by Meyer Children's Hospital IRCCS at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 40 years, women only
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- structural and functional MRI
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 24 Oct 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Anorexia Nervosa or Bulimia Nervosa patients between 12 and 40 years old
Who may be able to join
- Female sex
- Age between 12 and 40 years old
- Current diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Careggi, Firenze
Florence
Giovanni Castellini, 0039 055 794 7478, giovanni.castellini@unifi.it
- Recruiting
Meyer Children's Hospital IRCCS
Florence
Tiziana Pisano, 0039 055 5662907, t.pisano@meyer.it
About this study
Official title: Functional MRI During Resting State in Patients with Eating Disorders: a Longitudinal Prospective Study on Neuropsychopathological Correlates
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.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Being tested
- structural and functional MRI
- Keywords
- resting state fMRI, longitudinal evaluation
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
structural and functional MRIDiagnostic test
structural and functional MRI
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa - minors | Not described Receives: Diagnostic Test: structural and functional MRI | |
| Bulimia Nervosa - minors | Not described Receives: Diagnostic Test: structural and functional MRI | |
| Anorexia Nervosa - adults | Not described Receives: Diagnostic Test: structural and functional MRI | |
| Bulimia Nervosa - adults | Not described Receives: Diagnostic Test: structural and functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cortical thickness
Measured: baseline, 12 months post-enrollment
Weight restoration
Measured: baseline - 12 months post-enrollment
Child Behavior Checklist (CBCL) score
Measured: Baseline - 12 months post enrollment
Children's Depression Inventory (CDI) score
Measured: baseline, 12 months post-enrollment
Multidimensional Anxiety Scale for Children (MASC)
Measured: Baseline - 12 months post-enrollment
Eating Disorder Inventory (EDI) psychometric score
Measured: Baseline - 12 months post-enrollment
Secondary outcomes (4)
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.
Measured: baseline, 12 months post-enrollment
Change in Regional Homogeneity (ReHo) index
Measured: 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
Measured: 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.
Measured: Baseline - 12 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start24 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874348
- Sponsor's protocol ID
- RS-FMRI-ED
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI During Resting State in Patients with Eating Disorders: a Longitudinal Prospective Study on Neuropsychopathological Correlates
- ClinicalTrials.gov ID
- NCT06874348
- Acronym / sponsor ID
- RS-FMRI-ED
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Keywords
- resting state fMRI, longitudinal evaluation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa - minors | – | Diagnostic Test: structural and functional MRI |
| Bulimia Nervosa - minors | – | Diagnostic Test: structural and functional MRI |
| Anorexia Nervosa - adults | – | Diagnostic Test: structural and functional MRI |
| Bulimia Nervosa - adults | – | Diagnostic Test: structural and functional MRI |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Anorexia Nervosa or Bulimia Nervosa patients between 12 and 40 years old
Key inclusion criteria (3 listed)
- Female sex
- Age between 12 and 40 years old
- Current diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| structural and functional MRIstructural and functional MRI | Diagnostic test | Anorexia Nervosa - adults, Anorexia Nervosa - minors, Bulimia Nervosa - adults, Bulimia Nervosa - minors |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by Meyer Children's Hospital IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiziana Pisano (0039 055 5662907, t.pisano@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cortical thickness (time frame: baseline, 12 months post-enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.