AURORANCT07865546

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

StatusRecruiting

PhaseNot applicable

SponsorImago 7 Fondazione di Ricerca onlus

Primary completionOct 16, 2027 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 4, 2026 Study First Submitted

Endpoints

Primary

Spatial Resolution of Acquired Images

Timeframe: 0-36 months

Temporal Resolution of Acquired Images

Timeframe: 0-36 months

Secondary (3)

Image Signal Quality Across Imaging Techniques

Image Noise Across Imaging Techniques

Artifacts Across Imaging Techniques

Arms and interventions

Deep-Learning to achieve higher spatial and temporal resolution for functional neuroimagingExperimental

The intervention consist of the execution of the 7T MRI functional study of eloquent brain areas (including at least one among visual, sensorimotor or language function). No further visit following the MRI study will be scheduled for any participant. Each MRI study requires approximately 2 hours, including preparation. For a subgroup of volunteer subjects, two MRIs will be performed approximately two hours apart, before and after a specific research procedure (monocular deprivation) which serves to quantify plasticity of the visual system. For each volunteer, a total time commitment of approximately 5 consecutive hours is expected.

Diagnostic tests: Functional neuroimaging

Sites

1 site in 1 country

Imago7 FoundationPisa, Italy, Italy

About this trial

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.

Trial details

Enrollment: 180 participants (estimated)
Started: Oct 16, 2024
Study completion: Oct 16, 2027 (estimated)
Eligibility: 6 to 65, all sexes, healthy volunteers accepted
Design: Interventional, open label, diagnostic
Oversight: No data monitoring committee
Conditions: Brain Injuries, Epilepsy, Nervous System Diseases, Neurological Disorders, Neuroscience, Brain Injuries, Focal
Collaborators: Meyer Children's Hospital IRCCS, IRCCS Fondazione Stella Maris, University of Pisa
Official title: Advanced Space-time Resolved Techniques for fUnctional neuROimaging Characterization of Structurally Abnormal Eloquent coRtical Areas
First posted: Oct 8, 2026
Registry updated: Oct 8, 2026
Last verified: Oct 2026

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