The application of modern quantitative (structural and functional) MRI techniques to the study of MS patients is improving the understanding of the mechanisms responsible for the accumulation of irreversible clinical deficits in this disease. The identification of clinical, neuropsychological, and imaging biomarkers characteristic of the entire spectrum of MS, and the definition of standardized methods for their collection and analysis are central not only to improve the understanding of disease pathophysiology and evolution, but also to generate research hypotheses, monitor treatment, and increase cost-effectiveness and power of clinical trials.
The Italian Neuroimaging Network Initiative (INNI) involves centres and investigators with an International recognized expertise, with the major goal to determine and validate novel MRI biomarkers to be utilized as predictors and/or outcomes in future MS studies.
The first two goals of this initiative are:
- 1) The creation of a centralized repository of the available structural/functional MRI, clinical and neuropsychological data at the participating centers;
- 2) The use of such data to define the role of clinical, neuropsychological and imaging biomarkers (including diffusion tensor tractography and resting state fMRI) in understanding MS pathophysiology.
Subsequently, the INNI will aim at:
- 1) Developing a standardized acquisition protocol of advanced structural and functional MRI techniques to be applied for the study of MS patients;
- 2) Helping peripheral centers in the set up of this protocol, in order to homogenize the approach to MS patients at a national level;
- 3) Instructing neurologists involved in the cure of MS patients in the use, evaluation and interpretation of information derived from advanced MRI techniques;
- 4) Designing standardized and centralized procedures for daily-life implementation of advanced MRI measures.
This project will allow to identify novel clinical, neuropsychological and MRI biomarkers to be used to monitor disease evolution in patients with MS. Some of these biomarkers are likely to be applied in the context of clinical trials, to reduce costs, and also to investigate specific effects of treatments, not only pharmacologic, but also rehabilitative.
In addition, the definition of standardized MRI and clinical protocols for the evaluation of patients with MS in Italy will eventually allow integrating a large amount of data obtained from different centers, in order to test specific research hypotheses on disease pathophysiology and treatment effects.
To this aim, a web-based system of clinical, neuropsychological and MRI data will be implemented to allow data sharing.
In order to access to the data, a research proposal detailing the main objectives and advance in knowledge should be submitted to the Steering Committee (SC) for an approval.
Upon registration, users will have full access to the datasets, and the right to usage of the datasets for non-commercial purposes.