Active clinical trials for "Neurodevelopmental Disorders"

This project is the first involving the two most common neurodevelopmental disorders, ASD and ADHD, as well as TDC to establish a multi-dimensional database (clinic, behavior, neurocognitive function, brain imaging, metabolomics, and microbiome) using the same methodology. Based on this integrated multi-dimensional databank, we anticipate exploring metabolic flows of the gut-brain axis during brain development and identifying the common and unique biomarkers of ASD and ADHD and high-risk materials related to their functions and the underlying mechanism. Moreover, distinguishing the characteristics of the gut microbiota, gastrointestinal disorders, and microbial flora dysbiosis also helps us, in turn, to accelerate the process of identifying biological treatments that can interfere or slow down the severity of cognitive impairments in neurodevelopmental disorders. Eventually, we anticipate finding the clinical and neurocognitive measures related to the direct or indirect influence of gut-brain signaling. Our findings are anticipated to improve the knowledge about neurodevelopmental disorders, enhance developing early detection, diagnosis, and treatment for ASD and ADHD, and contribute to precision medicine.

Anti-epileptic drugs (AEDs) are potent teratogens associated with a spectrum of physical and neurodevelopmental anomalies to the exposed fetus. Particular risks include congenital malformations, impaired motor and cognitive functioning, autism and poorer educational attainment. Fetal exposure to drugs that bind to central nervous system targets as part of their therapeutic effect (e.g. neurotransmitter receptors and neuronal channels) appear to alter brain structure and function in both animal models and humans. Fetal magnetic resonance imaging offers an approach to investigate these effects in vivo, identifying biomarkers, defining the onset of abnormalities and dose response. Fetal MRI may offer risk stratification and identify patients that may benefit from intervention early in development. The overall aim of this study is to contribute to improving developmental outcomes following the inevitable exposure during treatment of maternal epilepsy. This novel study aims to explore the central nervous system with state-of-the-art non-invasive multimodal magnetic resonance imaging consistent with the University of Nottingham Precision Imaging Beacon, so as to improve outcomes in patients at risk of long term complex neuropsychiatric conditions.

The purpose of this study is to determine the effects of Central Nervous System Stimulants, represented by Methylphenidate and Modafinil, compared to placebo control on motor performance in children with Cerebral Palsy. This study will be a triple-masked study per the American Academy of Neurology guidelines for clinical trials.

This project aims to measure repetition suppression and tactile prediction using high-resolution electroencephalography in preschoolers, in order to describe the responses as a function of age, gestational age of birth and the presence of a neurodevelopmental disorder. We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. We will perform several behavioral evaluations to analyze the results in view of the quality of development.

The purpose of this research study is to evaluate the feasibility in conducting advanced MRI sequences in a pediatric clinical setting. The study will be observational in nature, and will only evaluate the studies of pediatric patients who have already been prescribed an advanced MRI for clinical neurological purposes. The only difference for the subject in participating in this study is that the data and information about their scan can be used and disclosed for research purposes, i.e. understanding if the time of the scan, patient comfort, and quality of the data are feasible. Standard MRI's have been extremely beneficial in the diagnosis and assessment of disease, injury, and anomalies throughout the body. Adding advanced MRI sequences to the arsenal of current standard MRI sequences, as well as analyzing the clinical significance of the data, may improve the benefits of MRI in the future. Within this scope, the study will be looking at the following factors: The total time of the scan, including: Patient arrival time/lateness Patient preparation time Time scanner is being occupied Patient compliance (is the patient continually stopping the study for breaks, fear, movement, etc.) Patient dropout rate, including: Change of mind Cost of study is too much Failure to finish the scan Usability of data, including: Movement artifact Patient requiring re-scan for any reason The scan will consist of two to five advanced MRI sequences that will average between 7-15 minutes each, in addition to a routine 5 minute standard MRI sequence. The variability in the number of advanced sequences depends on the prescription and patient history. All sequences are performed using a 1.5 Tesla Siemens MRI scanner at Westwood Open MRI, a 3 Tesla GE scanner at Tower Saint John's Imaging, or a 3 Tesla Siemens MRI scanner at Resolution Imaging. All scanners are FDA-approved.

The Huizhou mother-infant cohort was set up to investigate the effect of dietary factors and environmental exposures during pregnancy on health consequences of mothers and offsprings in Huizhou, China.

This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years.

This study is aimed to carry out a systematic study to examine the effects of genetic variants (genetic modifiers) other than TSC genes on phenotypic variability in familial TSC patients (affected parent, child and unaffected siblings) and sporadic TSC.

Developmental Coordination Disorder (DCD) corresponds to a clumsiness, a slowness and an inaccuracy of motor performance. This neurodevelopmental disorder affects 6% of school-aged children, and disturbs daily life activities and academic performances. The etiology of DCD is still unknown. An understanding of this disorder is necessary to improve interventions and therefore quality of life of these people. A deficit of the so-called internal models is the most commonly described hypothesis of DCD. Indeed, children with DCD exhibit difficulties in predictive control. Internal models, useful for motor control, are closely related to the sensory system, as they are elaborated on and constantly fed by sensory feedback. Deficits in sensory performance are described in DCD, mostly in the visual system, which could in turn partly explain poor motor performance. However, visuo-perceptual deficits cannot explain the entire motor difficulties because some activities in daily life, as buttoning a shirt, are often performed without visual control. Although the integrity of proprioceptive and tactile systems is necessary for the building of internal models, and therefore for a stable motor control, these sensory systems have been very little investigated in DCD. Moreover, using a tool is often disturbed in children with DCD. In neurotypical subjects, tool use induces a plasticity of body representation, as reflected by modifications of movement kinematics after tool use. Proprioceptive abilities are necessary for this update of the body schema. Thus, potential deficits of the proprioceptive system in children with DCD could impair the plastic modification of the body schema, and hence of motor performance, when using a tool. The aim of this study is to identify the main cause of the DCD, both by evaluating the tactile and proprioceptive abilities and by assessing the body schema updating abilities in children with DCD. While some daily life activities improve with age, some motor difficulties persist in adults with DCD. To our knowledge, perceptual abilities have never been investigated in adults with DCD and it is thus unknown whether perceptual deficits are still present in adulthood. This information could allow us to understand if motor difficulties in adult DCD are caused by enduring perceptual deficits and/or impaired plasticity of body schema. The second aim of this study is to evaluate abilities of perception and of body schema plasticity in adults with DCD.

Motor impairments are prominent in individuals with autism spectrum disorder (ASD) and other neurodevelopment disorders, and these impairments often impact the individual's ability to engage in organized physical activity programs (OPA). While many studies have identified dance and creative movement to be retrospectively and anecdotally therapeutic, there remains a paucity of literature regarding outcomes associated with these programs, and specifically, their impact on (1) perceived and objective gross and fine motor skills, (2) perceived ability to succeed in related or divergent goals or tasks, (3) quality of life for affected individuals and their caregivers. (4) adaptive function and socialization, (5) social communication This study explores the impact of organized dance and creative movement classes on children with autism (ages 8-12) and their caregivers. Participants will complete a set of surveys and assessments designed to measure the above metrics (labeled 1, 2, and 3) at their first study visit. This initial assessment is expected to take place within two weeks prior to beginning the intervention (either a wait period or a series of 1-hour dance classes, which children will attend weekly for 10 weeks). The second and final study visit will consist of a similar set of surveys and assessments designed to measure the same metrics within the two weeks following completion of the dance class series. Participants who have completed the wait period at this point will then begin their set of 10 weekly dance classes. Expected duration of participation in the study is no longer than 14 weeks in total.