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

ConditionsNeurological Disorders Neuroscience Epilepsy Brain Injuries, Focal

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-65

SponsorImago 7 Fondazione di Ricerca onlus

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Contraindications to 7T MRI;

Neuropsychiatric comorbidities preventing adequate collaboration during functional neuroimaging;

Pregnancy;

Refusal to receive information regarding incidental findings identified during MRI examination.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

180 Participants

are divided into 1 treatment group

Group A: Deep-Learning to achieve higher spatial and temporal resolution for functional neuroimagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Spatial Resolution of Acquired Images

\- Comparison of spatial resolution (voxel size in mm) of images acquired using the different implemented techniques

Time frame

0-36 months

Temporal Resolution of Acquired Images

\- Comparison of temporal resolution (in seconds) of images acquired using the different implemented techniques

Time frame

0-36 months

Secondary outcomes

Image Signal Quality Across Imaging Techniques

\- Evaluation of signal-to-noise ratio (SNR) obtained with the implemented techniques, including comparison of images before and after the application of noise correction algorithms;

Time frame

0-36 months

Image Noise Across Imaging Techniques

\- Evaluation of contrast-to-noise ratio (CNR) in images obtained with the implemented techniques, including comparison of images before and after the application of noise correction algorithms;

Time frame

0-36 months

Artifacts Across Imaging Techniques

\- Evaluation of artifacts types in images obtained with the implemented techniques, including comparison of images before and after the application of noise correction algorithms;

Time frame

0-36 months

Other outcomes

Electrophysiological Correlates of Functional Imaging

In patients with epilepsy (with or without brain malformations or lesions), comparison between activation maps obtained using optimized 7T fMRI sequences and EEG/stereo-EEG data

Time frame

0 - 36 months

Functional Activation and Connectivity in Patients and Controls

In clinical populations, including patients with drug-resistant epilepsy, with or without structural brain abnormalities (malformations or lesions) who are candidates for surgery, and patients with brain lesions acquired in the pre- or perinatal period, to compare activation patterns in eloquent cortical areas (visual and sensorimotor), cortico-subcortical connectivity, and signal propagation between patients and controls

Time frame

12-36 months

Functional Signal Change and Reproducibility Across Imaging Techniques

\- Analysis of functional activation maps/responses and connectivity measures acquired with the different techniques in terms of percentage signal change and reproducibility.

Time frame

0-36 months