overview

Sites who are willing to join the INNI network as participant sites should send to the Steering Committee a scientific project proposal. This proposal should be aimed, using neuroimaging tools, to a better diagnosis, a better understanding of the natural evolution, or a better monitoring of treatment efficacy in MS.

There are different modalities of participation to the INNI network, according to the characteristics of the requiring Institution (e.g., profit or no-profit) and to the willingness of sharing own data on the centralized database.

In particular, the following 4 modalities are foreseen:

No profit data contributors = no profit Institutions asking for access to the INNI database, that are willing to share a relevant number of own data in the online database. The quality of data to be uploaded will be evaluated by the Steering Committee. No profit data contributors will receive a login allowing the upload of clinical and neuroimaging data in the online database, and allowing to read basic information of the content uploaded by the other participating sites.

After receiving the project approval from the Steering Committee, no profit data contributors will have to sign the "Data User Agreement",upload their own data on the centralized database, to acknowledge "The INNI Group" and to include in the Author's list all INNI data contributors in any publication.
No profit data users = no profit Institutions asking for access to the INNI database, that are not willing to share any (or a limited number of) own data in the online database. According to the project proposal presented by the Users, the Steering Committee will decide whether: a) the Users can access to restricted data of the database, or b) results of the requested analysis will be sent to the User, without any access from the User to the database information. No profit data users will receive a login allowing to read only limited information of the content uploaded by the other participating sites.

After receiving the project approval from the Steering Committee, no profit data users will have to sign the "Data User Agreement", to acknowledge "The INNI Group" and to include in the Author's list all INNI data contributors in any publication.
Profit data contributors = profit Institutions/Companies asking for access to the INNI database, that are willing to share a relevant number of own data in the online database. The quality of data to be uploaded will be evaluated by the Steering Committee. The results of the requested analysis will be provided to the Institution/Company, without any access from the profit contributor to the complete dataset.

Profit data contributors will receive a login allowing the upload of clinical and neuroimaging data in the online database, and allowing to read only limited information of the content uploaded by the other participating sites.

After receiving the project approval from the Steering Committee, profit data contributors will have to sign the "Data User Agreement", upload their own data on the centralized database, acknowledge "The INNI Group" and to include in the Author's list all INNI data contributors in any publication.
Profit data users = profit Institutions/Companies asking for access to the INNI database, that are not willing to share a relevant number of own data in the online database. The results of the requested analysis will be provided to the Institution/Company upon payment, without any access from the profit user to the data in the online database.

After receiving the project approval from the Steering Committee, profit data users will have to sign the "Data User Agreement", to acknowledge "The INNI Group" and to include in the Author's list all INNI data contributors in any publication.

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Multiple sclerosis (MS) is the most common chronic inflammatory demyelinating disease affecting the central nervous system (CNS) of young adults in Western countries leading, in the majority of cases, to severe and irreversible clinical disability. From the earliest days of magnetic resonance imaging (MRI), it was evident that, because of its sensitivity in revealing focal white matter (WM) abnormalities, it would have become a valuable tool for the assessment of patients with MS. This has been the case in the diagnostic work-up of patients with a suspicious of this condition, as well as in those with confirmed MS, to elucidate the mechanisms underlying disease progression and to monitor the accumulation of pathology underpinning disability. A considerable effort has also been devoted to develop imaging strategies capable of providing an accurate estimate of the extent of disease-related damage. There are established guidelines for integrating MRI findings into the diagnosis of patients who present with clinically isolated syndromes (CIS) suggestive of MS, and specific acquisition protocols have been suggested for monitoring longitudinal changes in patients with an established disease. However, in MS research, conventional MRI has been substantially overcome by quantitative MRI techniques, which have shown greater sensitivity and specificity for assessing the heterogeneous pathological substrates of the disease not only in focal T2-visible lesions, but also in the normal-appearing white matter (NAWM) and gray matter (GM). In addition, the advent of functional imaging techniques, complementing structural/anatomical assessment, is providing novel markers to gather important in vivo pieces of information on brain functions.

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FISM, Fondazione Italiana Sclerosi Multipla, funding the project "The Italian Neuroimaging Network Initiative (INNI) to optimize the use of advanced MRI techniques in patients with MS" and owner of the database.

Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, San Raffaele Scientific Institute, Fondazione Centro San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Principal Investigator: Prof. Massimo Filippi.
Department of Neurology and Psychiatry, "La Sapienza" University, Rome, Italy.
Co-investigator: Prof. Patrizia Pantano.
Department of Neurological Sciences, University of campania "Luigi Vanvitelli" and Care ''Hermitage Capodimonte", Naples, Italy.
Co-investigator: Prof. Gioacchino Tedeschi.
Department of Neurological and Behavioural Sciences, University of Siena, Siena, Italy.
Co-investigator: Prof. Nicola De Stefano.

The INNI network is leaded by a Steering Committee. Members of the Steering Committee are the Principal Investigator (Prof. M. Filippi), the leaders of the other sites proposing INNI (Prof. P. Pantano, Prof. N. De Stefano, Prof. G. Tedeschi and Dr. M.A. Rocca), and representatives of the Fondazione Italiana Sclerosi Multipla (FISM), who is the owner of the database, according to the italian law on copyright. The Steering Committee ensures that the INNI project adheres to the study design and methodology laid out in the grant submission.

In particular, the Steering Committee is responsible to:

Deciding on admission of additional participants to the INNI network
Deciding on the composition of the Steering Committee
Reviewing the requests of project proposals requiring a download of data from the centralized database, and decision about their approval or rejection
Monitoring and updating the web site www.inni-ms.org
Identifying and approving external funding

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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.

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The Italian Neuroimaging Network Initiative (INNI)

The INNI project aims at establishing an italian network, involving 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 studies of multiple sclerosis.

FISM, Fondazione Italiana Sclerosi Multipla, funding the project "The Italian Neuroimaging Network Initiative (INNI) to optimize the use of advanced MRI techniques in patients with MS" and owner of the database.

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