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NCT07865546
Advanced Space-time Resolved Techniques for Functional Neuroimaging at 7 Tesla MRI
Conditions: Neurological Disorders, Neuroscience, Epilepsy, Brain Injuries, Focal
Sex: All
Ages: 6 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 180
Sponsor: Imago 7 Fondazione di Ricerca onlus
Location: Imago7 Foundation Pisa Italy
Summary
In recent years, the in vivo study of the central nervous system has undergone significant advancement through the implementation of magnetic resonance imaging (MRI)-based neuroimaging techniques. In particular, the advent of high- and ultra-high-field MRI systems has substantially contributed to a deeper understanding of the pathophysiological mechanisms underlying neurological diseases and has supported the development of personalized approaches in medicine. In the field of neuroimaging, the application of MRI techniques to investigate brain function and connectivity in vivo is increasingly expanding at ultra-high magnetic field strength (7T).
This research project aims to develop, implement, and optimize advanced techniques to improve image quality through deep learning-based approaches and real-time monitoring of magnetic field fluctuations, with the goal of achieving functional neuroimaging at very high spatial and temporal resolution on a 7T scanner.
These techniques will be applied in healthy volunteers to address fundamental questions in basic neuroscience, as well as in clinical populations with central nervous system disorders, including patients with focal epilepsy and patients with congenital brain lesions associated with persistent neurological deficits.
The basic neuroscience component will allow investigation of mechanisms of brain function and connectivity between eloquent cortical regions and subcortical structures. In the clinical setting, improved delineation of activation maps in eloquent brain areas and characterization of their reorganization under pathological conditions are expected to enhance personalized therapeutic decision-making and deepen our understanding of neuroplasticity mechanisms, with potential impact on clinical care pathways.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07865546). StuddyBuddy aggregates publicly available trial information.