Periodic Reporting for period 4 - BRAINTEASER (BRinging Artificial INTelligencE home for a better cAre of amyotrophic lateral sclerosis and multiple SclERosis)
Periodo di rendicontazione: 2025-01-01 al 2025-06-30
BRAINTEASER (BRinging Artificial INTelligencE home for a better cAre of amyotrophic lateral sclerosis and multiple SclERosis) addressed the challenge of improving care and quality of life for patients with Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS). These neurodegenerative diseases are progressive, highly variable, and place a considerable burden on individuals, families, and healthcare systems. Traditional clinical management relies on episodic consultations, limiting the ability to provide timely, personalised interventions.
BRAINTEASER tackled this gap by developing AI-driven tools for early risk prediction, disease monitoring, and personalised decision support. These tools integrate heterogeneous data sources—clinical, environmental, behavioural, and wearable sensor data—through a privacy-compliant infrastructure. Importantly, the project also empowered patients via digital health apps and engaged caregivers and clinicians in co-creating solutions.
The project’s core objectives were:
- To create AI models for personalised disease progression prediction and patient stratification.
- To develop digital tools for patients and clinicians to support remote monitoring and decision-making.
- To integrate environmental exposure data into clinical models.
- To provide actionable insights for healthcare professionals and policymakers.
- To support regulatory and ethical compliance and foster long-term data sharing through the European Open Science Cloud.
Concluding the project, BRAINTEASER successfully delivered multiple validated innovations reaching TRL6–7, with several tools under active exploitation. The final activities focused on preparing exploitation pathways, regulatory roadmaps (SaMD), public health recommendations, and sustainable data management plans. The project established a strong foundation for continued impact beyond its funding period.
BRAINTEASER tackled this gap by developing AI-driven tools for early risk prediction, disease monitoring, and personalised decision support. These tools integrate heterogeneous data sources—clinical, environmental, behavioural, and wearable sensor data—through a privacy-compliant infrastructure. Importantly, the project also empowered patients via digital health apps and engaged caregivers and clinicians in co-creating solutions.
The project’s core objectives were:
- To create AI models for personalised disease progression prediction and patient stratification.
- To develop digital tools for patients and clinicians to support remote monitoring and decision-making.
- To integrate environmental exposure data into clinical models.
- To provide actionable insights for healthcare professionals and policymakers.
- To support regulatory and ethical compliance and foster long-term data sharing through the European Open Science Cloud.
Concluding the project, BRAINTEASER successfully delivered multiple validated innovations reaching TRL6–7, with several tools under active exploitation. The final activities focused on preparing exploitation pathways, regulatory roadmaps (SaMD), public health recommendations, and sustainable data management plans. The project established a strong foundation for continued impact beyond its funding period.
Over the course of the BRAINTEASER project, the consortium developed and integrated a comprehensive set of tools and models aimed at transforming the care pathway for ALS and MS patients. Key achievements include:
- AI-based models for patient stratification, progression prediction, and risk assessment, capable of integrating clinical, sensor, and environmental data.
- A patient mobile app enabling self-reporting, continuous feedback, and remote symptom tracking, and a clinical dashboard for monitoring patients and supporting timely interventions.
- A data infrastructure ensuring secure, GDPR-compliant data management and interoperability, supporting long-term sharing in alignment with FAIR principles.
- An AI simulation platform integrated with InSilicoTrials to support in silico clinical research and regulatory engagement.
- An open Community of Practice (CoP) bringing together patients, caregivers, clinicians, and researchers to foster exchange, learning, and dissemination.
Throughout the project, dissemination was actively pursued through scientific publications, open challenges, policy dialogues, and public events. Over 40 open-access papers, 3 public data challenges, and multiple stakeholder engagements were conducted. Patient associations and clinicians contributed to co-design and validation activities, increasing relevance and trust.
In the final period, efforts focused on delivering key strategic outputs:
- Exploitation plans and business models for key innovations (e.g. AI tools, apps, platform services).
- Public health recommendations on digital transformation in care delivery.
- Roadmaps for certification of software as medical device (SaMD).
- The final update of the Data Management Plan and alignment with EOSC and long-term data reusability.
BRAINTEASER outcomes are currently being adopted or evaluated for real-world use and are well-positioned for continued impact in both clinical and industrial settings.
- AI-based models for patient stratification, progression prediction, and risk assessment, capable of integrating clinical, sensor, and environmental data.
- A patient mobile app enabling self-reporting, continuous feedback, and remote symptom tracking, and a clinical dashboard for monitoring patients and supporting timely interventions.
- A data infrastructure ensuring secure, GDPR-compliant data management and interoperability, supporting long-term sharing in alignment with FAIR principles.
- An AI simulation platform integrated with InSilicoTrials to support in silico clinical research and regulatory engagement.
- An open Community of Practice (CoP) bringing together patients, caregivers, clinicians, and researchers to foster exchange, learning, and dissemination.
Throughout the project, dissemination was actively pursued through scientific publications, open challenges, policy dialogues, and public events. Over 40 open-access papers, 3 public data challenges, and multiple stakeholder engagements were conducted. Patient associations and clinicians contributed to co-design and validation activities, increasing relevance and trust.
In the final period, efforts focused on delivering key strategic outputs:
- Exploitation plans and business models for key innovations (e.g. AI tools, apps, platform services).
- Public health recommendations on digital transformation in care delivery.
- Roadmaps for certification of software as medical device (SaMD).
- The final update of the Data Management Plan and alignment with EOSC and long-term data reusability.
BRAINTEASER outcomes are currently being adopted or evaluated for real-world use and are well-positioned for continued impact in both clinical and industrial settings.
BRAINTEASER advanced significantly beyond the state of the art in digital health for neurodegenerative diseases by delivering integrated, explainable AI solutions tailored to real-world settings. Unlike conventional approaches relying on static clinical data, BRAINTEASER combined multimodal, real-time patient data—wearables, app-based questionnaires, environmental exposure, and clinical indicators—into predictive models that support both patients and professionals.
The project’s models incorporate disease progression dynamics and uncertainty, allowing simulations over time, stratification of patient subgroups, and generation of in silico patients—tools valuable not only for care delivery but also for designing more efficient and ethical clinical trials. Innovations were designed with future SaMD certification in mind, ensuring compliance with regulatory requirements and enabling broader adoption in clinical settings.
The socio-economic impact of BRAINTEASER is considerable. The tools empower patients, especially those with mobility limitations, enabling safer, more autonomous care at home. For clinicians, real-time monitoring reduces reliance on episodic visits and supports more proactive, personalised care decisions. This can reduce hospital admissions, improve outcomes, and optimise healthcare resources. Public health stakeholders benefit from insights linking pollution exposure to disease patterns, contributing to policy recommendations.
Societally, BRAINTEASER supports the shift toward precision medicine and citizen-centric digital health. It fosters health literacy through its CoP and directly addresses digital inclusion by co-developing tools with patients and caregivers. The integration of environmental data into clinical models is novel and timely, contributing to better understanding the interplay between pollution and neurodegeneration.
By project end, BRAINTEASER has delivered validated tools and infrastructures ready for real-world testing and uptake, created a strong community around digital health for ALS and MS, and aligned with both EOSC and regulatory frameworks. These results lay the groundwork for continued clinical, scientific, and societal impact beyond the project's lifetime.
The project’s models incorporate disease progression dynamics and uncertainty, allowing simulations over time, stratification of patient subgroups, and generation of in silico patients—tools valuable not only for care delivery but also for designing more efficient and ethical clinical trials. Innovations were designed with future SaMD certification in mind, ensuring compliance with regulatory requirements and enabling broader adoption in clinical settings.
The socio-economic impact of BRAINTEASER is considerable. The tools empower patients, especially those with mobility limitations, enabling safer, more autonomous care at home. For clinicians, real-time monitoring reduces reliance on episodic visits and supports more proactive, personalised care decisions. This can reduce hospital admissions, improve outcomes, and optimise healthcare resources. Public health stakeholders benefit from insights linking pollution exposure to disease patterns, contributing to policy recommendations.
Societally, BRAINTEASER supports the shift toward precision medicine and citizen-centric digital health. It fosters health literacy through its CoP and directly addresses digital inclusion by co-developing tools with patients and caregivers. The integration of environmental data into clinical models is novel and timely, contributing to better understanding the interplay between pollution and neurodegeneration.
By project end, BRAINTEASER has delivered validated tools and infrastructures ready for real-world testing and uptake, created a strong community around digital health for ALS and MS, and aligned with both EOSC and regulatory frameworks. These results lay the groundwork for continued clinical, scientific, and societal impact beyond the project's lifetime.