Revolutionising multiple sclerosis monitoring and rehabilitation through “gamification”

LIH to take part in innovative R-MMS clinical trial

• Clinical Research
• Research Projects & Clinical Trials
• Translational Medicine Operations Hub (TMOH)
• Clinical and Epidemiological Investigation Center (CIEC)
• Clinical Project Management Office (CPMO)
• Competence Centre for Methodology and Statistics
• Donation
• Department of Medical Informatics

The Luxembourg Institute of Health (LIH), together with the Luxembourg Institute of Science and Technology (LIST), will be participating in an international multi-site clinical trial aiming to test and validate a novel neurotechnology developed by company Myelin-H for the remote monitoring and neurorehabilitation of Multiple Sclerosis. This ambitious venture will gather clinical centres from the UK, the US, Australia, Luxembourg, Belgium, the Netherlands and Italy, in order to test Myelin-H’s proprietary software on over 150 patients.

More than 2.8 million individuals worldwide live with multiple sclerosis (MS). Unlike many other neurological disorders, MS often emerges in one’s 20s or 30s and stands as the primary cause of disability among younger adults. Recent data reveals that over 42% of patients do not receive adequate treatment during the initial phase of the disease, termed relapsing-remitting MS (RRMS). Furthermore, more than 50% of MS sufferers experience silent disability progression. Although MS remains incurable, appropriate treatment can effectively manage symptoms, address relapses, and slow RRMS progression. However, there is a growing need to remotely monitor medication efficacy and, crucially, track silent disease progression and cognitive decline in RRMS patients. Currently, magnetic resonance imaging (MRI) stands as the sole method available for monitoring MS progression, but its inherent limitations, such as high costs, logistical challenges, and the necessity for hospitalisation, call for the development of new innovative remote-monitoring solutions.

In this context, Myelin-H has developed a novel “software-as-medical-device” (SaMD) for the remote home-based monitoring and neurorehabilitation of MS patients. The SaMD is a non-invasive software platform that combines mobile neuroscience-based cognitive games, a wearable visor-like brain-computer interface sensor, a machine learning engine for real-time data interpretation, and a real-time clinical dashboard. While patients play Myelin-H’s cognitive games on their phones for a few minutes, various biosignals from the patient’s brain and body are captured and translated into digital biomarkers and clinical scores, which are then shared via an online medical report along with clinical recommendations. This can help health professionals detect early and rapid disease worsening and prescribe appropriate treatment.

Specifically, the R-MMS clinical trial will aim to test whether the SaMD technology can accurately monitor disease progression and patient response to treatment, particularly when compared to the current gold standard. In addition, the study will ascertain whether the technology can predict the occurrence of relapses and enhance cognitive abilities.

The LIH will participate in the study as a consultant through the Clinical and Epidemiological Investigation Center (CIEC), the Clinical Project Management office (CPMO) and the Competence Center for Methodology and Statistics (CCMS), which will assist Myelin-H with the development of the protocol, regulatory submissions to receive clinical investigation approvals, as well as with the methodology and study design.

“By gamifying the neurological assessment and rehabilitation process, our solution helps ensure patients’ compliance and willingness to perform such sessions at home, thereby improving the monitoring of the disease, slowing its progression and reducing its burden on daily life and on healthcare systems”, says Dr Zied Tayeb, founder and CEO of Myelin-H.

We are thrilled to be lending our expertise in all phases of clinical trial management to such an innovative project, which has the potential to tangibly improve the lives of many patients worldwide. We look forward to contributing to confirming the effectiveness of this novel technology, a crucial step which will subsequently allow the device to become CE-marked and ready to be integrated into clinical practice,

concludes Dr Manon Gantenbein, Head the CIEC & CPMO.

Funding and collaborations

The R-MMS clinical trial is a collaborative effort between Myelin-H, the Luxembourg Institute of Science and Technology (LIST), the Luxembourg Institute of Health, and various clinical experts and partner institutions across the world. The project has been funded through the HealthTech call organised jointly by the Luxembourg National Research Fund (FNR) and the Ministry of Economy.