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NCT06985303
The goal of this study is to explore a new treatment that may help repair brain damage in individuals with periventricular leukomalacia (PVL), a condition that affects white matter in the brain. Researchers are testing whether a combination of a novel cell therapy and specific molecular agents can support brain repair. The main questions the study aims to answer are: Can the treatment help regrow white matter and improve myelin repair? Does the treatment reduce scarring in the brain? Is the treatment safe and well-tolerated? The study uses several components, including: A specific type of neural progenitor cell to form the basis of the therapy. A small molecule compound to support cell function and survival. An agent designed to promote the repair of the myelin sheath. An enzyme intended to break down scar tissue in the brain. Researchers will study how these components work together to protect and repair the brain by influencing key pathways involved in damage and recovery.
NCT03672877
This is a randomized controlled trial, comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of gross motor function in young children with spastic diplegia.
NCT02221219
Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury and related disabilities later in life. Despite its prevalence, long term consequences, and enormous medical and social costs, mechanisms of IVH and optimal strategies to prevent or treat its occurrence are poorly defined, especially for extremely premature infants. Only one medical therapy, prophylactic indomethacin during the first 3 days of life, has been shown to prevent or decrease the severity of IVH in preterm infants, but its use is limited by toxic side effects and debatable effects on long-term outcomes. Several small studies and case reports suggest that delayed umbilical cord-clamping (DCC) may also decrease the incidence of IVH in premature infants, but thus far these trials have indomethacin treatment mixed within their cord clamping protocols. The investigators are conducting a randomized, blinded investigation of 4 treatment groups: 1) Control (no intervention); 2) DCC alone; 3) Prophylactic indomethacin alone; 4) Combination of DCC/indomethacin, with respect to survival, IVH or PVL incidence and severity, neurodevelopmental outcomes, and relevant mechanistic effects. With the steady rise in extreme prematurity births and clear links of IVH to long-term disabilities there is a need to improve care for these patients. This multi- disciplinary project addresses an important medical problem for an understudied patient population, where the current practice has clear limitations.
NCT02342990
Periventricular Leukomalacia (PVL) is a white matter lesion surrounding the lateral ventricles of the brain occurring in the prenatal period, associated with a disorder of movement and posture, known as bilateral cerebral palsy. Children with PVL and bilateral cerebral palsy have spared verbal abilities, as measured by verbal Intelligence Quotient (verbal IQ) tests, while non-verbal intelligence and especially visuo-perceptual and visuo-spatial abilities are impaired. In addition some studies underline the impact of PVL also on executive function, especially in terms of working memory and in the ability to inhibit distraction. Working Memory is the ability to retain and manipulate information for brief periods of time. It is important in several complex cognitive functions, such as academic learning and in planning and organizing daily life activities. School-based activities, indeed, such as math and reading depend on a student's ability to pay attention to several instructions or information and to hold and integrate them in their mind. Recent behavioural and neurofunctional studies describes the effect of an evidence-based and computer-based training on working memory, the Cogmed Working MemoryTraining. Functional MRI show increase in parietal and prefrontal activity after this training, while the behavioural data demonstrate the generalization of this effect also on cognitive functions not directly trained, as attention, inhibition, learning and non-verbal reasoning. Cogmed Working MemoryTraining (RoboMemo®, CogMed-Cognitive Medical Systems, Stockholm, Sweden) is an online treatment comprising a number of visuo-spatial and verbal exercises that vary automatically depending on the individual child's performance in any given task. The training period is intensive and includes 25 home session for five weeks, 30-45 minutes each day. A Cogmed-trained coach monitors training progress and participants' commitment daily. Only one ongoing study has used the CogMed training in children with cerebral palsy, but without investigating the correlation between behavioural findings with neurofunctional data. The aim of this study is to analyze the effect of the working memory training with CogMed on trained and not directly trained cognitive abilities and on the changes in cortical electrophysiological reorganization during the sleep after training. The sleep analysis will be focused in particular on the slow waves activity \[frequency range of 1-4.5 Hz\] and on the sleep spindle \[frequency range of 12-14Hz\], which reflect the depth of sleep and are related to memory processes, learning and brain plasticity. The results of this project will shed light on the mechanisms of neuroplasticity, by enhancing knowledge on the neuropsychological effects of a specific working memory training and on the neurophysiological underpinnings of these behavioural effects in a clinical population of children with congenital brain lesions, as PVL.