Advanced 7T fMRI for brain function in epilepsy and brain injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project aims to develop and optimize advanced 7T MRI and fMRI techniques to improve image quality and temporal resolution using deep learning and real-time field monitoring. It includes functional neuroimaging to study brain function and networks, potentially aiding personalized diagnostics. The study will involve healthy volunteers and patients with drug-resistant epilepsy or brain lesions who may be candidates for surgical treatment, using strict Italian-language informed consent and assent as appropriate. This work builds on prior evidence that 7T MRI can reveal epileptogenic areas and subcortical functional specializations with greater detail than lower-field systems.

Why it matters

Who can join: the full rules

Inclusion criteria Healthy Volunteers

* Age ≥ 18 years;
* No history of diagnosed psychiatric disorders;
* Sufficient understanding of the Italian language (required both for informed consent and for comprehension of fMRI task instructions);
* Provision of written informed consent.

Patients

* Age 6-65 years;
* Diagnosis of drug-resistant epilepsy (PMID: 19889013), with or without structural brain abnormalities, and candidate for surgical treatment (PMID: 21145290, 24497269, 31876960), or presence of pre-, peri-, or post-natal brain lesions documented by prior brain MRI;
* Normal intellectual functioning or mild cognitive impairment sufficient to ensure adequate collaboration during the 7T functional neuroimaging study;
* Sufficient understanding of the Italian language (required both for informed consent and comprehension of fMRI task instructions);
* Provision of written informed consent (and assent when applicable, according to age and regulations).

Exclusion Criteria (All Participants)

* Contraindications to 7T MRI;
* Neuropsychiatric comorbidities preventing adequate collaboration during functional neuroimaging;
* Pregnancy;
* Refusal to receive information regarding incidental findings identified during MRI examination.

Where it's running

• Imago7 Foundation
  Pisa, Italy, Italy Recruiting

Study contacts

• Study coordinator: gilda gallucci
• Email: gilda.gallucci@fsm.unipi.it
• Phone: 0039 050886233

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.