Teleneurorehabilitation (phase II)

Project Title:

Application of Artificial Intelligence methods to TELENEURORABILITATION: validation of procedures, features extraction for outcome prediction, users’ compliance and engagement evaluation.

Leader:

IRCCS San Raffaele, Rome

Project Manager:

Prof. Paolo Maria Rossini

This project has been funded by Italian Ministry of Health (RICERCA CORRENTE – RETE IRCCS 2022-FONDO PROGETTI) and aims to complement the previous RIN research programme through:

a) Validation of the harmonisation procedures for data acquisition and TELENEURORABILITATION (TNR) medical devices used in major adult and paediatric neurological disorders, particularly with regard to the protection of ‘sensitive data’;

b) Completion of recruitment, where necessary, to achieve a statistically valid sample size;

c) Data analysis for the prediction of outcomes and compliance through artificial intelligence methods.

Project start:

01/01/2022

Participating IRCCS:

IRCCS San Raffaele, IRCCS Fondazione Santa Lucia, IRCCS Centro Neurolesi Bonino Pulejo, IRCCS Ospedale San Raffaele, IRCCS Fondazione Don Carlo Gnocchi, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, IRCCS Fondazione Stella Maris, IRCCS ICS Maugeri, IRCCS Istituto delle Scienze Neurologiche, IRCCS Fondazione Istituto Neurologico Casimiro Mondino, San Camillo IRCCS, IRCCS Istituto Clinico Humanitas, IRCCS Associazione Oasi Maria SS, IRCCS Istituto Nazionale Tumori Regina Elena, IRCCS Ospedale Pediatrico Istituto Giannina Gaslini, IRCCS Ospedale Pediatrico Bambino Gesù, IRCCS Istituto Neurologico Carlo Besta, IRCCS Eugenio Medea.

Technology partners involved:

CBIM, Khymeia

Clinical Research The Clinical Research project is divided into several phases:
  • Implementation of procedures for sharing and accessing protected data

  • Completion of Patient Recruitment

  • Uploading data onto the platform

  • Data analysis

  • Selection and application of the most appropriate artificial intelligence softwares

The platform, developed by the technology partners, contains clinical and instrumental data collected with harmonised procedures and tools. In the current project, these data – once their ‘sensitive’ content has been protected in accordance with the Law and Regulations – will be integrated and analysed to assess whether patients with major acute/chronic-progressive neurological diseases can benefit from remote TNR.

State of the art and time schedule:

The coordinating IRCCS (San Raffaele-Roma) has been the promoter of an intensive campaign to adapt its procedures for the protection of ‘sensitive data’ with the development of documents and protocols that follow the directives of the law.

The CBIM Consortium set up the RedCap platform and uploaded the eCRFs provided by the IRCCSs responsible for the individual WPs. It sent the links for uploading data and is supporting the IRCCSs in entering the collected clinical data. The Khymeia Group is supporting the project IRCCSs in the input of instrumental data from the tablets to the common platform.

Protocols initiated
  • TeleICTUS protocol: responsible centre: IRCCS Centro Neurolesi Bonino Pulejo. Standardisation of clinical protocols useful for telerehabilitation intervention, optimisation of remote data transmission procedures and creation of a computer network for data sharing. In addition, the evaluation of the network infrastructure definition phase, the protocol definition phase in specific clinical scenarios and the home equipment set-up were completed.

  • Protoollo TeleSM: responsible centre: IRCCS Fondazione Don Carlo Gnocchi. To evaluate, in the population with MS so far enrolled in the CBIM web-based cloud platform, the efficacy of Virtual Reality Rehabilitation System (VRRS) treatment combined with active (anodal) transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex versus placebo tDCS stimulation combined with VRRS, versus VRRS treatment alone, versus Usual Care (UC) treatment; to characterise the best candidate for effective TNR and NM intervention in patients with MS.

  • TeleParkinson protocol: responsible centre: IRCCS Istituti Clinici Scientifici Maugeri. Aimed at demonstrating the feasibility, in PD patients, of a home-based TNR programme and the VRRS system; evaluating the effects of this programme on QoL and functional outcomes through the analysis of standardised data, assessment scales for motor and non-motor symptoms; evaluating the compliance of PD patients Assessment of treatment enjoyment by patients and their caregivers.

  • COGNITIVE TELENEURHYDRATION (MCI) protocol: responsible centre: IRCCS Istituto San Giovanni di Dio Fatebenefratelli. To evaluate the efficacy of VRRS treatment combined with active (anodal) transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex compared to: – tDCS placebo stimulation combined with VRRS on some cognitive functions; – VRRS treatment alone; – UC treatment. In addition, the possibility of prolonging the beneficial effects of treatment with an innovative TR system will be evaluated.

  • Sensorimotor and cognitive tele-rehabilitation protocol in children with rare and cerebrovascular diseases: responsible centre: IRCCS Stella Maris Foundation. To identify, by means of AI methods, in the population of children with cognitive and/or motor disabilities, so far enrolled in the previous RIN-TABLET project of the RIN 2020, specific digital biomarkers of their cognitive and motor performance; to analyse the acceptability and usability of technologies in clinical and home settings for their assessment and TR; conduct a small pilot study to evaluate the effectiveness of TR using the VRRS home environment in a homogeneous group of children with motor and cognitive disorders due to rare or cerebrovascular diseases; analyse and interpret the results in children together with AI methods developed for adults to investigate age-related characteristics.

  • Neuromotor/dementia telerehabilitation protocol: responsible centre: IRCCS Fondazione Santa Lucia. To retrospectively explore the potential impact of patient compliance and adherence on primary and secondary outcomes of already performed TNR studies on cognitive and language functions in patients with cognitive disorders.

RIN Annual Meeting December 2023

This year, following the delegation of the Governing Council of the Neuroscience IRCCS Network, the IRCCS San Raffaele is organising the 3rd Annual Meeting IRCCS Neuroscience and Neurorehabilitation Network to be held in Rome, during which the results of the Teleneurisation network project will be presented.