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RECRUITING Not applicable ClinicalTrials.gov

Advanced Space-time Resolved Techniques for Functional Neuroimaging at 7 Tesla MRI

Sponsor: Imago 7 Fondazione di Ricerca onlus • ClinicalTrials.gov ID: NCT07865546

Registry updated: 2026-10-08
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Description

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.

Interventions

  • Functional neuroimaging (Diagnostic test)
    Novel advanced method based on Ultra High Field-MRI for personalised functional neuroimaging by depicting tiny neuronal MR signal fluctuations at high spatial and temporal resolution. Two approaches will be investigated: 1. Enhanced image quality for both structural and functional MRI through: a) DL-based denoising and sharpening reconstruction (arXiv:2008.06559) developed, tested and optimized for functional and connectivity studies; b) anti-aliasing DL reconstruction techniques (PMID: 31247254) implemented to achieve higher spatial and temporal resolution with respect to the current state of the art; c) field monitoring using the field camera developed and implemented to correct several dynamic field disturbances that result in image distortions and artifacts (PMID: 28077303). 2. Development of a novel, non-invasive, 3D whole-brain, direct functional neuroimaging method, with unprecedented sensitivity in order to resolve tiny neuronal MR signal fluctuations

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.

Conditions

Neurological Disorders Neuroscience Epilepsy Brain Injuries, Focal

Locations

  • Imago7 Foundation — Pisa, Italy, Italy
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record