Province Of Pisa

Researchers are investigating the brain's action observation network (AON), focusing on its detailed anatomical and functional characteristics, particularly in subcortical areas and the cerebellum. The study aims to understand how these brain regions interact in healthy individuals and in patients with Cerebral Palsy (CP), a condition caused by early brain injury. They want to see if patterns of brain activation differ in CP patients and how these relate to their clinical symptoms. Participants will undergo a 7 Tesla MRI scan using advanced imaging protocols that provide very high spatial resolution to capture detailed brain structures and functions. The study includes both healthy subjects and CP patients. The MRI protocol involves anatomical and functional scans, including visual tasks where participants watch videos of hand actions. CP patients also receive a thorough clinical assessment before the MRI. The imaging sequences are designed to explore the entire AON circuit, including the cerebellum and subcortical nuclei. During the study, participants will be monitored for their ability to remain still during long imaging sessions to reduce motion artifacts. Researchers will collect detailed brain activation maps and connectivity maps using ultra-high field MRI. They will also record clinical and functional data from CP patients. The primary outcomes include analyzing brain activation patterns and connectivity to better understand AON organization and its reorganization after early brain damage. The study involves a single MRI visit with comprehensive assessments.

Researchers are studying children and adolescents with neuromotor impairments to improve cognitive skills often affected in this group. The study focuses on enhancing abilities like visual-perceptual analysis, selective attention, working memory, narrative organization, logical reasoning, and motor planning. It also aims to assess children's behavioral, cognitive, and emotional engagement when interacting with a social robot, as well as to explore if the benefits of the intervention extend to other cognitive functions such as inhibition and planning. Participants will be divided into two groups: an Experimental Group receiving training with a social robot using a Learning by Teaching approach and a Control Group continuing standard care initially. The training involves helping the robot reorder sequences of pictures from figurative stories to create coherent narratives or motor actions, delivered biweekly over about four months. After this period, the Control Group will begin the training, and all children will be reassessed. This approach is designed to increase engagement and develop executive functions through active teaching roles. Children will undergo initial neuropsychological, motor, and school learning assessments before training begins. Throughout the study, researchers will use sensors, eye-tracking, and video recordings to monitor engagement levels. Primary outcomes include scores on the Picture Arrangement subtest of the WISC-III and a Motor Planning test measured over 1 to 16 months. Follow-up assessments will occur after the training phase to evaluate cognitive improvements and the generalization of effects to other executive functions.

Researchers are studying children with Cerebral Palsy who have crouch gait to see if using the Agilik powered orthosis at home for two months can improve knee extension during walking and increase endurance. The study also aims to understand the safety of the Agilik device. Participants will be compared between those using the Agilik powered exoskeleton and those receiving standard therapy. Participants will either use the Agilik device at home for 2 months, walking with it for 30 minutes a day, 5 days a week, or undergo standard therapy. The study includes visits to the clinic at the start, after 3 months, and again after 4 months to monitor progress and outcomes. During the study, researchers will measure endurance and knee extension during walking at the start, 3 months, and 4 months. Assessments include physical evaluations and monitoring for any medical issues related to the device. The total participation lasts about 4 months, with follow-up visits to check on safety and improvements.

Researchers are investigating whether a multisensory version of Action Observation Treatment (AOT), which combines visual, auditory, and tactile stimuli, can activate the Mirror Neuron System (MNS) more effectively than traditional visual-only AOT. This pilot study focuses on children and adolescents with Cerebral Palsy (CP), a common childhood motor disorder, and compares them with typically developing peers aged 7 to 25 years. The aim is to understand how immersive multisensory stimulation affects neural activation related to motor functions and motor imagery abilities. Participants will take part in two separate EEG sessions in random order. In the immersive session, they will watch first-person videos with matching sounds and tactile feedback using specialized haptic gloves adapted for children. The traditional session involves watching the same videos without sound or tactile stimuli. After observation in both sessions, participants will perform or imagine the actions shown. Eye tracking will monitor attention during the videos, and brain activity will be recorded using a 128-channel high-density EEG net. Sessions are video-recorded to assess motor behavior and protocol adherence. Following each EEG session, participants will complete motor imagery questionnaires suited to their age and perform a task involving imagining interrupted actions based on previously viewed videos. The study will analyze differences in neural responses between the two types of sessions and explore relationships between brain data, attention, questionnaire responses, motor imagery performance, and clinical assessments. Each EEG session lasts about one hour, and the study includes 20 children or adolescents with CP and 20 matched typically developing controls.

Researchers are evaluating the effectiveness of multi-domain robotic and technological rehabilitation compared to standard single-domain rehabilitation in children and young adults aged 5 to 21 years with neuromotor impairments. The study aims to see if a holistic rehabilitation approach that addresses motor, cognitive, and speech therapy needs can lead to greater improvements in everyday life performance, motivation, active participation, and satisfaction using the Canadian Occupational Performance Measure (COPM) as a primary outcome. Participants are assigned to either a multi-domain intervention group, which combines multiple technological or robotic devices tailored to each child's needs along with conventional multi-level rehabilitation, or a single-domain intervention group, which uses only one technological or robotic device plus the conventional program. Treatments consist of at least 20 sessions lasting 2 hours each, organized in two schedules: 4 weeks with 5 sessions per week or 7 weeks with 3 sessions per week. During the study, children will be evaluated three times using clinical outcome measures including the COPM at baseline, up to 7 weeks, and 2 months after treatment ends. Researchers will collect demographic, clinical, and technological data while monitoring adherence through treatment diaries and independent clinical reviewers. Data will be securely stored and analyzed to compare outcomes between groups and assess functional improvements and satisfaction over time.

Cerebral Palsy (CP) is a leading cause of childhood disability, affecting motor development and involving sensory, communication, cognitive, and emotional challenges. This research aims to create a national digital platform in Italy that collects standardized clinical, instrumental, and genetic data from children and adolescents with CP. The goal is to better understand the prevalence of different types of CP and the severity of functional impairments and related health issues. This study is observational, involving patients from multiple centers across Italy and includes both retrospective and prospective data collection. The study involves enrolling at least 300 children and adolescents aged 4 to 18 years with CP, from three clinical centers in northern, central, and southern Italy. Participants' clinical data will be collected using a hospital-based registry, including comprehensive diagnostic and monitoring information such as neuroradiological and electrophysiological data. Data are recorded in an anonymized format using a secure platform. Enrollment will be ongoing, with progress monitored quarterly to track the number of participants and study adherence. Participants will provide demographic information, CP classification, medical history, functional ability levels, and comorbidities. No new medical treatments or biological samples will be collected. The study follows patients according to their routine clinical visits, with no additional evaluations required. Recruitment will last 12 months, and the overall study period is 36 months. Researchers will analyze the collected data to understand CP epidemiology better, without using a control group.

Researchers are studying the use of a new portable robotic system called PhiCube to help improve upper limb function in children aged 4 to 18 years who have congenital or acquired neuromotor disorders, as well as those with Developmental Coordination Disorder (DCD). This pilot phase multicenter clinical study aims to assess the feasibility and effectiveness of PhiCube in enhancing movement planning and control. The study uses standardized tests to measure movement quality and daily hand function before and after treatment. The treatment involves robotic bilateral upper limb rehabilitation using PhiCube, a modular device with two motorized axes that assist or resist movements. Participants undergo 30 sessions over about 3 months, with 3 sessions per week lasting 45 minutes each. The program combines motor training with gaming elements designed for children, focusing on improving range of motion, accuracy, dexterity, and smoothness of movement through controlled, repetitive exercises tailored to individual needs. Participants are assessed at four time points: two before treatment starts and two after treatment ends. Evaluations include the Melbourne Assessment-2 to measure upper limb movement quality and the Abilhand-Kids questionnaire completed by parents or caregivers to assess daily bimanual activities. Additional tests evaluate neuropsychological processing and auditory feedback effects. Data will be analyzed to compare outcomes across different diagnostic groups, with ongoing monitoring throughout the study period.

Electrocardiogram (ECG) Q-T prolongation is a heart rhythm disorder linked to potentially dangerous arrhythmias. Certain psychotropic drugs can increase the risk of QT prolongation, so doctors usually perform a baseline ECG before prescribing these medications. However, there is no established guideline on when to repeat ECG tests during ongoing treatment or which clinical signs should prompt additional monitoring. This research studies how often QTc prolongation occurs as a side effect in children and adolescents taking psychotropic drugs long term. ECGs will be recorded at the start of treatment and then again at 3, 6, and 12 months to analyze changes and factors that could affect QT intervals. Participants will have ECGs recorded over the course of their treatment, with assessments at several points to track heart rhythm changes. The main measure is how the QT interval changes from baseline through 18 months after enrollment. This monitoring aims to better understand the timing and risk of QT prolongation with psychotropic medications in young patients.

Researchers are evaluating the effectiveness of BHV-7000 in treating adults with refractory focal onset epilepsy, a condition where seizures originate in specific areas of the brain and have not responded to previous treatments. This Phase 2/3 trial aims to assess the safety, tolerability, and ability of BHV-7000 to reduce seizure frequency in participants who continue to have seizures despite using anti-seizure medications. The study follows classification criteria set by the International League Against Epilepsy and includes participants aged 18 to 75 years. Participants will be randomly assigned to receive either BHV-7000 at doses of 50 mg or 75 mg once daily, or a matching placebo, in a double-blind setup where neither participants nor researchers know which treatment is given. The treatment period focuses on monitoring changes in seizure frequency over 28-day averages from baseline through weeks 8 to 16. The study design includes careful control and comparison to evaluate the investigational drug's impact. During the study, participants will keep accurate seizure diaries to track their seizures. Researchers will measure changes in the average number of seizures over 28-day periods as the primary outcome. Safety and tolerability will also be monitored closely. The study requires participants to be currently treated with one to three anti-seizure medications and to meet specific epilepsy criteria. Overall participation includes screening, treatment, and follow-up to assess the drug's effects and participant safety.