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37 active trials for Neurodevelopmental Disorders

RCT of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes

Randomized controlled trial of PR-ESSENCE treatment for youth with challenging behavior in two youth treatment homes, including 60-70 youth. Inclusion criteria: Youth aged 12-17 years, staying at least 3 months at the home, with intellectual function in the normal range according to WISC-test and clinical judgment, and exhibiting significant problem behaviors as measured by Broset Violence Checklist (BVC). Subjects are randomized to 10 weeks of PR-ESSENCE treatment or to the control condition "treatment as usual". After the control period, the control group will receive 10 weeks of PR-ESSENCE treatment. Outcome is assessed at baseline, post-treatment/control period, and 3-6 months post-treatment (at the time when the youth is planned to move from the home) with global assessments of problem severity and improvement by blinded rater (CGI-I, CGI-S), ratings of SNAP-IV (ADHD and oppositional symptoms), ECBI (behavior problems) and RPQ (relation problems) by the youth's contact person, and self-ratings of psychiatric symptoms and self-concept with Becks Youth Inventories. BVC ratings are also made daily by contact persons and teachers during the whole study.

Start: January 2021

BALANCED GROWTH: The Involvement of the Vestibular System in a Child's Cognitive and Motor Development

When a vestibular dysfunction occurs at birth or in early stages of life, one might expect that this may have an enormous impact on a child's development. It is known that a severe congenital or early acquired vestibular deficit in children results in delayed psychomotor milestones. Later in life, children with a vestibular dysfunction may have difficulties with several balance tasks and additional cognitive, motor and/or psychosocial performances. While a few authors have suggested that there is indeed an influence of a vestibular dysfunction upon these different developmental domains (cognitive, motor, educational and psychosocial development), which can be supported by findings in clinical practice as well, literature concerning this topic remains fairly limited. On the other hand, several studies have shown that children with known difficulties in motor and/or cognitive functions have more difficulties in vestibular performances in comparison with their unaffected peers. Although more frequently discussed, the literature on this population is rather scarce too. Therefore, the current project aims to investigate the relationship with and the involvement of the vestibular system in the motor and cognitive development of school-aged children.

Start: July 2019

PANDA Gym: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability

Early childhood detection of motor delays or impairments provides the opportunity for early treatment which improves health outcomes. This study will use state of the art sensors combined with machine learning algorithms to develop objective, accurate, easy-to-use tools for the early scoring of deficits and lays the foundation for the early prediction of physical disability.

Start: November 2020

Nutrition and Pregnancy Intervention Study

A randomized double-blind placebo controlled intervention study with pregnant obese women (n=440) will be conducted. The intervention will involve consumption of fish oil and/or probiotic capsules from early pregnancy until 6 months after delivery. The aim of the study is firstly to investigate the effects of the supplements on the risk of gestational diabetes mellitus and obesity in the women and secondly to modify the risk markers of allergy and obesity in children of the women. Also the underlying metabolic mechanisms will be investigated. Follow up visits at child's age of 5 to 6 years will be conducted to evalute long-term effects on maternal and child health. The aim is to investigate the impact of dietary intervention, diet, maternal overweight/obesity and gestational diabetes status as well as gut microbiota and metabolism during pregnancy on maternal and child's health, allergy and child neuropsychological development.

Start: October 2013

Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

Organizational, time management and planning (OTMP) skills deficits are impairing features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD), which compromise school performance and family relations. The manualized Organizational Skills Training program (OST) was designed to target children's specific OTMP deficits. However, the brain mechanisms of treatment-induced changes remain unknown. The current study combines a training intervention (OST) with non-invasive MRI imaging in a pre-/post-design in a randomized two-arm (treatment vs. waitlist) trial to address this question.

Start: October 2019

Translating Peer-to-Peer Support Into a Clinical Setting

There is not a lot of research focusing on Black and African American families raising young children with developmental delays. While the investigators know that early intervention helps children and their families, Black children with developmental delays are less likely to access such services. The causes for these racial disparities are largely unknown. Researchers have recommended caregiver support programming while on waitlists to improve caregiver-provider interactions and caregiver knowledge of the diagnostic process and developmental delays. Once a child is referred to a clinic for developmental concerns, long appointment waitlists contribute to further delays in timely diagnosis and treatment, as well as parental distress. Support programs for waitlisted families can begin to address these challenges. In this study, the investigators will examine a program called Parents Taking Action with families on a waitlist for a specialty developmental evaluation. The investigators will study if the program is feasible in this setting, if participants like the program, and if child and parent outcomes improve after participants have completed the program.

Start: September 2020

Prenatal Iodine Supplementation and Early Childhood Neurodevelopment

A randomized controlled trial to determine the effect of reducing iodine from vitamin and mineral supplements for pregnant women who have adequate iodine intakes (>185 ?g/d from food alone) on cognitive development of children at 24 months of age.

Start: November 2020

The Biomarkers of Neurological Disease in Utero Study

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.

Start: June 2019

A Natural History Study of hnRNP-related Disorders

The purpose of this study is to analyze patterns in individuals with hnRNP genetic variants, including their neurological comorbidities, other medical problems and any treatment. The investigators will maintain an ongoing database of medical data that is otherwise being collected for routine medical care. The investigators will also collect data prospectively in the form of questionnaires, neuropsychological assessments, motor assessments, and electroencephalography to examine the landscape of deleterious variants in these genes.

Start: June 2018

Developmental Origins of Mental Health Disorders

Common mental disorders (CMD) such as Depression, contributes significantly to the global burden of disease. Fetal exposure to adverse intrauterine environment mediated by life course factors can enhance risk of non-communicable disease in later life. Maternal micronutrients such as Vitamin B12 and folate play an important role in early fetal development through their effect on one carbon metabolism. Vitamin B12 deficiency is common in Indian women; however guidelines recommend only iron, folic acid supplementation during pregnancy. This study aims to investigate effects of maternal B12, folate during pregnancy on mental health and neurocognitive outcomes in offspring during adulthood. The Pune Maternal Nutrition Study(PMNS) birth-cohort(n=762) was established in 1993 at the Diabetes Unit of KEM Hospital Pune with well characterized serial data and archived biological samples. The subjects of the cohort are now in age range of 20-22 years and this provides an opportunity to examine the proposed objectives. Key objectives: To examine the specific association between maternal vitaminB12, folate, homocysteine levels at 18 & 28 weeks of gestation and risk for CMD, neurocognitive outcomes. Examine the causality of this association by Mendelian randomisation using genetic determinants of vitamin B12 and homocysteine. Design and analysis: Consenting members of the birth cohort of PMNS (n=690) will be recruited after ethics approval. Following cross-sectional outcome measures will be measured Neurocognitive functions: using standardized neuropsychological battery Brain imaging for Structural and functional magnetic resonance imaging (MRI). Temperament-character dimensions (TCI):140 item short TCI-R. Structured clinical interview for CMD, Diet, physical activity, High-risk behaviors, Early life stress. Serum Brain Derived Neurotrophic factor (BDNF), Insulin like growth factor (IGF-1) from serum archived at 6,12 & 18 years. Longitudinal methods and multivariate regression analysis would be used to investigate the hypothesized associations. Path analysis will be used to generate pathways of evolution of the abnormalities. Causality of the associations will be assessed by Mendelian randomization analysis (triangulation and instrumental variable analysis) using maternal genetic determinants of vitamin B12 and homocysteine

Start: May 2018

Wearable Sensors and Video Recordings to Monitor Motor Development

The objective of this study is to develop an automated, precise, quantitative assay for detecting atypical motor behavior and development in infants using data from wearable sensors and video recordings.

Start: March 2019

Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development

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.

Start: February 2020

Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach)

Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. Service use and the cost vs. benefits of the ENGAGE approach compared to usual practice will also be examined. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites in Alberta, Canada will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. This study will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. After the study, children, parents and therapists will be asked to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve efficiency of paediatric rehabilitation services.

Start: September 2020

Childhood Outcomes of Preterm Brain Abnormalities

Prematurely born children are at higher risk of cognitive impairments and behavioral disorders than full-term children. There is growing evidence of significant volumetric and shape abnormalities in subcortical structures of premature neonates, which may be associated to negative long-term neurodevelopmental outcomes. The general objective is to look directly at the long-term neurodevelopmental implications of these neonatal subcortical structures abnormalities. Investigators propose to develop biomarkers of prematurity by comparing the morphological and diffusion properties of subcortical structures between preterm, with and without associated brain injuries, and full-term neonates using brain MRI. By combining subcortical morphological and diffusion properties, investigators hypothesize to be able to: (1) delineate specific correlative relationships between structures regionally and differentially affected by normal maturation and different patterns of white matter injury, and (2) improve the specificity of neuroimaging to predict neurodevelopmental outcomes earlier. The specific aims and general methodology are: 1) Build a new toolbox for neonatal subcortical structures analyses that combine a group lasso-based analysis of significant regions of shape changes, a structural correlation network analysis, a neonatal tractography, and tensor-based analysis on tracts; 2) Ascertain biomarkers of prematurity in neonates with different patterns of abnormalities using correlational and connectivity analysis within and between structures features; 3) Assess the predictive potential of subcortical imaging on neurodevelopmental outcomes by correlating neonatal imaging results with long-term neurodevelopmental scores at 9 and 18 months, and 6-8 years, follow-up. In each of these aims, investigators will use advanced neuroimaging analysis developed by their group and collaborator, including multivariate tensor-based morphometry and multivariate tract-based analysis. This application will provide the first complete subcortical network analysis in both term and preterm neonates. In the first study of its kind for prematurity, investigators will use sparse and multi-task learning to determine which of the biomarkers of prematurity at birth are the best predictors of long-term outcome. Once implemented, these methods will be available to compare subcortical structures for other pathologies in newborns and children.

Start: March 2018

Altered Cerebral Growth and Development in Infants With Congenital Heart Disease

Background: Congenital heart disease (CHD) is the most frequent inborn defect with an incidence of 1 in 100 newborns per year, i.e. 800 children born in Switzerland per year. 10% to 15% of cases are born with single ventricle (SV), the most complex type of CHF requiring immediate surgical intervention after birth. Infants with SV CHD are treated in three surgical staged procedures over the first three years of life. However, cerebral injuries occur in around 40% of those children and impact neurocognitive abilities. As more than 90% of all infants with CHD survive to adulthood, scientific concern is focussed on patient-individual course brain growth and development within the relative contribution of fetal, perinatal, cardiac and surgical risk factors. Therefore, serial cerebral MRI examinations are needed, starting (1) at the third trimester during fetal life proceeding to (2) pre- and postoperative time points at the stage I surgery after birth and (3) before stage II surgery at 4 months of age. We will compare the cerebral MRI findings with a healthy control population, recruited at the same time points, and correlate brain growth and development with the neurodevelopmental outcome assessed at one year of age. Three Pediatric Heart Centers in Switzerland and Germany will participate. The overall aims are: To analyse the patient-individual cerebral developmental trajectories, brain growth and determine the time course of brain abnormalities in infants with single ventricle CHD by serial cerebral MRI during fetal life, after birth and at an age of 4 months (primary endpoints). To determine the neurodevelopmental outcome at one year of age using the Bayley III and will be correlated with the brain growth and brain development in the third trimester of fetal life and at the age of 4 months (secondary endpoints). To analyse fetal, neonatal, surgery-related and intensive care associated factors determining the patient-individual course for altered cerebral growth and impaired neurodevelopmental outcome at one year of age. Methodology: We will prospectively enroll fetuses and neonates with single ventricle CHD at the three Pediatric Heart Centers in Switzerland (Zurich, Bern) and Germany (Giessen). Advanced MR imaging will assess cerebral volumes, microstructural and hemodynamic changes at repeated time points during the third trimester of fetal life (32. week of gestation), the perioperative neonatal period before and after stage I surgery and before stage II surgery at 4 months of age. Biomechanical analysis of longitudinal changes of brain morphology will be applied to longitudinal fetal and neonatal MRI data. Outcome is determined with the Bayley-III at one year of age. Significance: Using a population-based sample of children with single ventricle CHD, we will be able to determine cerebral growth from the third fetal trimester until the first 4 months after birth, when the brain is most rapidly growing. By performing serial brain imaging, the knowledge of etiological pattern affecting cerebral growth, development and brain injury will increase. Morphometric and biomechanical analysis of brain growth patterns will be performed that may capture fine-grained changes associated with CHD. By correlating these data with the neurodevelopmental outcome at one year of age it will be possible to identify specific risk constellations leading to impaired brain development and categories of brain injuries that confer a higher risk of adverse outcome. The better understanding of the pathophysiological mechanisms will serve as the basis for neuroprotective studies and pharmacological trials aiming to improve outcomes in children with CHD in the future.

Start: January 2020

Shenzhen Birth Cohort Study

The Shenzhen Birth Cohort Study was set up to investigate the effect of early life environmental exposures on short- and long-term health consequences in Shenzhen, China.

Start: March 2018

SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism

Locomotor, transport and information functions in human body systems are carried out by active media in autowave regimes! Any living organism is a (micro-macro-mega) hierarchy of autowave subsystems-an ensemble of loosely coupled subsystems of a simpler structure. From the highest levels of the hierarchy, Autowave Codes-Signals arrive, which determine the transitions of subsystems from one autowave regime to another Autowave interaction (of Complex Coherent Action). Autowave interaction is a process associated with the evolution and interaction of spatial and wave structures in the active media of the organism. Chaos in organism functioning tells about health. Periodicity - Autowave reverberator may presage a disease - Autism Spectrum Disorder; Chaotic nature of oscillations in active media of physiological systems is more optimal for their vital functions than periodic one. Firstly, systems that function in chaotic regimes, can re-arrange themselves faster and easier in case of change of environmental conditions, i.e. the so called adaptive control is more easily implemented in them. Secondly, "spreading" of oscillations strength along comparatively wide frequency band takes place in chaotic regime. When an organism is young and healthy, physiological systems show the elements of chaotic behavior, i.e. irregularity and chaotic dynamics are the extremely important characteristics of health. Decrease in changeability and appearance of stable periodicity of Autowave reverberator are often connected with Autism. The main purpose is to study brain plasticity (the changes that occur in the brain through Autowave reverberator) in children with autism. Research suggests that during development, the brains of children may change in response to their Autowave reverberator differently than the brains of typically developing individuals. Investigators want to understand why and how this difference may contribute to the symptoms of autism spectrum disorder (ASD). In this study, the investigators will be examining the effects of non-invasive neuromodulation SQUED™ series 28.1 home-use for Treatment of Autowave reverberator of Autism. Integrative Team World Organization of Medical Synergetics (WOMS) - collaborations between physicians and researchers with expertise in biostatistics, physics, mathematics, engineering, and computer science.

Start: September 2017