Clinical trials

GLIOMAID is a scientific research project focused on improving how brain tumors, specifically gliomas, are diagnosed and managed. It uses Artificial Intelligence (AI) to analyze MRI brain scans and patient data. The project collects existing clinical information and imaging from glioma patients to build AI models that support doctors in making better and faster treatment decisions.Gliomas, especially high-grade ones, are among the most common and challenging brain tumors. Many patients have poor survival chances, and diagnosis often requires invasive procedures like biopsies. Despite medical advances, current treatments have limited effectiveness. Better non-invasive diagnostic tools are urgently needed to: * Detect tumors earlier. * Predict how aggressive they are. * Help doctors plan the most effective treatments. The GLIOMAID study aims to reduce the need for invasive diagnostics by creating AI tools that interpret brain scans with high accuracy. Primary Objectives * Create Italy's First Glioma Imaging Database This database will store anonymized MRI scans and clinical records from around 700 patients. * Improve Early Detection Develop AI systems to identify brain tumors earlier from MRI scans. * Automate Tumor Mapping Use AI to outline tumors on MRI images to assist with surgical planning and treatment follow-up. * Non-Invasive Tumor Characterization Train AI models to predict tumor type and severity without needing a biopsy. Secondary Objectives * Study how well AI tools fit into research and future clinical workflows. * Test how well AI can predict changes in tumors over time. Lead Institution: University of Trento and Santa Chiara Hospital, Trento (Prof. Silvio Sarubbo, Principal Investigator). Partner Hospitals: 7 neurosurgery and neuro-oncology centers across Italy. Inclusion Criteria * Adults aged 18-60 with a confirmed glioma diagnosis (from 2019 to 2024). * Patients who had surgical tumor removal, with or without further treatment (e.g., chemotherapy, radiotherapy). * MRI scans and basic clinical data must be available. Exclusion Criteria * Poor quality or incomplete MRI scans. * Missing essential clinical information. * If consent is explicitly refused (when it can be obtained). Clinical Data * Age, sex, diagnosis date. * Tumor type and genetic information. * Treatments received (surgery, chemo, radiation). * Patient outcomes (e.g., survival, tumor progression). Imaging Data * Pre- and post-operative MRI scans (T1, T2, FLAIR). * Segmented images highlighting tumor areas and post-surgery cavities. * Time points: before surgery, up to 6 months post-op, and during follow-up. All data is pseudonymized (no personal identifiers) and securely stored. Expected Results * Faster, more accurate diagnosis. * More personalized treatment planning. * Reduced need for invasive biopsies. Benefits for Patients and Doctors Patients: Earlier diagnosis, less invasive procedures, better treatment outcomes. Doctors: Improved decision-making tools, automated image analysis, consistent data for treatment planning.

Visual impairment (VI) has significant implications not only for visual functioning, but also for the motor development, psychological well-being, and social participation of children and adolescents. Despite the fundamental role of physical activity in promoting health, autonomy, and quality of life, young people with VI still participate to a limited extent in structured physical activity programmes, owing to the lack of adapted interventions supported by robust scientific evidence. The European VIPPSTAR project (Horizon Europe 2024), conducted at the University of Trento, aims to address this gap through the development and validation of an integrated system of educational and rehabilitation interventions designed to promote the motor, physiological, and psychosocial competences of children and adolescents with VI. This study marks the transition from the validation of the exercise battery in a controlled setting, carried out during the first phase of the VIPPSTAR project, to its implementation in participants' everyday environments. The aim is to assess its effectiveness, sustainability, and impact on psychophysical and relational well-being. The study has a longitudinal, non-profit experimental design and will involve 20 children and adolescents with VI aged 10-17 years (50% female and 50% male), recruited through lower- and upper-secondary schools in the Autonomous Province of Trento participating in the project. The intervention programme lasts 12 weeks and is divided into two blocks. During Block 1 (8 weeks), participants will complete the motor exercise battery twice weekly in the school setting, under the supervision of Abilnova educators. Sessions will take place twice a week, last approximately 45-60 minutes, and will be accompanied by fortnightly group meetings with classmates aimed at promoting social inclusion. During Block 2 (4 weeks), participants will perform the exercises at home, with the aim of consolidating the skills acquired and promoting autonomy in carrying out physical activity exercises, while continuing the fortnightly peer sessions at school. The effectiveness of the programme will be evaluated using a pre-post design (T0-T1), with an intermediate assessment at the end of Block 1 (T0.5). An integrated assessment system will be used, including ComfTech® wearable devices for continuous monitoring of physiological parameters, such as heart rate, respiratory rate, body temperature, SpO₂, and ECG; video systems for the assessment of motor and postural performance; standardised questionnaires assessing quality of life and social participation; and structured observation grids during peer sessions. Data will be transmitted to the AVATAR system, a conversational system developed within the project, which processes physiological and kinematic information in real time. AVATAR does not operate autonomously and does not make medical decisions. The results will contribute to validating an adapted, sustainable, and transferable exercise battery, laying the foundations for large-scale applications in clinical, educational, and rehabilitation settings, with potentially significant benefits for the quality of life and autonomy of young people with VI.

The study, entitled "PotenziaMente: Cognitive Training in Aging," is a clinical trial designed to evaluate the effectiveness of an individualized tablet-based cognitive training program targeting executive functions (e.g., planning, cognitive flexibility, and problem solving) in healthy older adults. Executive functions are higher-order cognitive processes that support adaptive functioning in daily life and influence other cognitive domains, such as memory. The primary aim of the study is to enhance cognitive performance, specifically executive functioning, in neurologically healthy adults aged 65 to 75 years. A secondary aim is to compare the effects of two different delivery modalities of the same cognitive training program: home-based self-administration via tablet versus supervised tablet-based training in the presence of a trained researcher. Participants will undergo cognitive assessments at baseline (pre-training), immediately after the intervention (post-training), and at a 3-month follow-up. This is a randomized parallel-group interventional clinical trial without masking. Participants are randomly assigned to one of two groups: a home-based cognitive training condition, in which they perform an individualized tablet-based cognitive training program targeting executive functions independently at home via a tablet application without direct supervision, or a supervised cognitive training condition, in which they perform the same individualized tablet-based cognitive training under the supervision of a trained researcher in a controlled environment. The intervention consists of two sessions per week, 1 hour per session, for 4 consecutive weeks, delivered via tablet-based exercises. The study uses a parallel assignment model with a prospective design and a primary purpose of treatment (cognitive enhancement and prevention of cognitive decline). The primary outcome is the change in executive functioning from baseline to post-intervention, assessed using standardized neuropsychological tests. Secondary outcomes include between-group differences (home-based vs. supervised) in executive functioning, changes in global cognitive functioning from baseline to post-intervention, and maintenance of cognitive effects at the 3-month follow-up.