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37 active trials for Neurodevelopmental Disorders

Etiology and Early Diagnosis of Neurodevelopmental Disorders

The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.

Start: May 2012

Experience With a Pediatric Summer Intensive Therapy Program

The purpose of this study is to explore the lived experiences of children with neurodevelopmental diagnoses and their caregivers with an intensive model of therapy. Children will receive usual care during the summer intensive program and the investigators will access medical records to assess effectiveness. Children and caregivers will also be asked to participate in semi-structured interviews upon the completion of the episode of care.

Start: May 2021

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants

This study will evaulate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD and MAD) and food effect (FE) of RO6953958 following oral administration in healthy male participants.

Start: July 2020

Swaddling to Improve Neurodevelopment for Preterm Babies

The investigators will test a new medical grade swaddling system for optimal and more appropriate positioning for preterm infants. This is a trial focused on sleep state, state regulation and long-term neurodevelopment. The central hypothesis is that this novel swaddling method will promote sleep and an optimal sleep-wake cycle, while also improving the neurodevelopment of preterm infants. It is proposed that adequate positioning and secondary feedback of natural movement of arms and legs stimulates and fosters normal brain development.

Start: July 2021

Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties,

Double blind, placebo-controlled, randomised trial, multicentre in France with open-label tolerability phase. The double-blind placebo-controlled study duration will be scheduled for 3 months with the final visit of the double-blind period at D84. After the D84 assessment, patients will be invited to continue into a 6-month openlabel study extension (OLSE) with ex-Sialanar® patients continuing the treatment and ex-placebo patients starting Sialanar®

Start: May 2021

Neurodevelopment of Hypoglycemic Neonates

The investigators propose to prospectively conduct a neurodevelopmental evaluation of SGA and late preterm neonates who underwent risk-based screening for hypoglycemia at newborn nursery during the first 24 hours of life based on AAP (American Academy of Pediatrics) hypoglycemia guidelines at 18 to 24 months of age. As per internal neonatal unit protocol (reflecting AAP guidelines), all neonates at risk of hypoglycemia (all preterm infants, term infants who are SGA or LGA and IDM) are routinely screened for hypoglycemia during the first 24 hours of life via bedside point of care glucose devices (see attached Weiler NICU hypoglycemia screening protocol) . The investigators will compare neurodevelopmental outcomes of those who were and were not hypoglycemic in the newborn nursery based on electronic health record data.

Start: June 2021

"Let's Get Organized" in Adult Psychiatric/Habilitation Care

This project aims to evaluate and establish evidence for a novel, group-based intervention that can help people with cognitive limitations due to mental or neurodevelopmental disorders to improve their ability to manage time and organize activities. This might provide an important step towards establishing healthy life habits, getting or maintaining employment, and managing family life. Time management is a necessary skill for maintaining healthy life habits and daily occupations in modern society. People with limited cognitive function due to, for example, mental or neurodevelopmental disorders, have documented difficulties in time management, which is also related to issues with self-efficacy. Common interventions for persons with poor time management are time-assistive devices and products, but studies show that these devices alone are not enough to cover these people's needs. Structured training is needed, but there is a lack of structured interventions to enhance time management skills. The intervention program "Let's get organized" (LGO) is a manual-based group intervention aiming to enhance time management, targeted to persons with mental or neurodevelopmental disorders. In a recent feasibility study the LGO showed promising results. This project aims to evaluate to what extent the LGO intervention is effective in improving time management, and satisfaction with daily occupations. The proposed project is a randomized-controlled trial carried out in ten psychiatric units in Sweden. Participants (n=104) will be randomly assigned to either LGO group intervention or individual Occupational Therapy intervention for ten weeks .The primary outcome of the study is self-reported time management measured by the Assessment of Time Management Skills. Secondary outcomes are occupational balance, self-efficacy, parental competence and cost-effectiveness.

Start: August 2018

3D-Transition: Challenges and Resources of Children and Their Families During the Transition From Preschool to School

The 3D-Transition study is a follow-up of the 3D Cohort pregnancy study (NCT03113331, which covered from the 1st trimester of pregnancy to age 2 years) as the children transition into kindergarten and first grade. It aims at clarifying prenatal and preschool predictors of challenging and successful transitions to school as measured by mental health and academic outcomes.

Start: May 2017

Enhancing Behavior and Brain Response to Visual Targets Using a Computer Game

Participants will play a computer game that is controlled by their gaze patterns and designed to direct attention their attention to specific on-screen targets. Visual attention to targets will be rewarded. Both visual behavior and brain response will be recorded during game play. It is hypothesized that that, over the course of the game, relative to baseline, participants will show (a) increased looking to targets, (b) decreased response time to targets, and (c) enhanced, more efficient neural response to visual cues. It is hypothesized that clinical variability will associate with visual attention and brain response.

Start: April 2014

Neural Correlates of Tactile Prediction

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.

Start: April 2021

Analyzing Retinal Microanatomy in ROP

Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that may impact vision in vulnerable preterm neonates for a lifetime. This study utilizes new technology to determine visual and neurological development of very preterm infants in the intensive care nursery, during a period of rapid growth of the retina, optic nerve and brain. The long-term goal of this study is to help improve preterm infant health care via objective bedside imaging and analysis that characterizes early critical indicators of poor vision, neurological development and ROP, which will rapidly translate to better early intervention and improved future vision care.

Start: March 2016

Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)

Infants with Neurodevelopmental Disabilities (ND) show emotional, cognitive and socio-interactive dysregulation dramatically impacting on caregiving behavior. Early family-centered rehabilitation interventions are effective in promoting better infant outcomes and in optimizing healthcare systems economic return in the long-term. The Video Feedback intervention (VFI) is effective in promoting sensitive parenting and supporting infants' development. In the light of limited resources of the healthcare systems, technological advance in telemedicine may facilitate the delivery of VFI to a greater number of families of infants with ND. Consistently, the Supporting Parenting at Home: Empowering Rehabilitation through Engagement (SPHERE) project is a randomized controlled trial (RCT) aiming at assessing effectiveness and efficacy of an early family centered VFI parenting support delivered through videoconferencing on dyads with infants with ND.

Start: January 2021

Combined Gut-brain Therapy for Children With Autism

CLINICAL ISSUE: Children with Autism Spectrum Disorder (ASD) are four times more likely to suffer with functional gastrointestinal disorders (FGIDs) than their neurotypical peers. The presence of FGIDs are linked to increased undesirable behaviour and ASD severity. Current behavioural approaches for ASD therapy do not alleviate the high comorbidity of FGIDs within this population. BACKGROUND: Dysfunction of the microbiome-gut-brain (MGB) axis has been implicated in pathogenesis of both ASD and FGIDs. Probiotics and prebiotics can modulate the gut microbiome and research has shown efficacy at improving gastrointestinal (GI) symptoms in children with ASD and neurotypical (NT) children with FGIDs. Gut-directed hypnotherapy (GDH) has shown utility in treating FGIDs in NT children and adults but has not yet been trialed in children with ASD. Targeting therapies to address the dysfunction of the bidirectional MGB axis will likely be more effective than either brain/behavioural or gut-based therapy alone. HYPOTHESIS: A synbiotic (prebiotic + probiotic mixture) with combined GDH will be more effective than a synbiotic alone at reducing GI symptoms in children with ASD aged 5.00 to 10.99 years over a 12-week period.

Start: December 2020

Neurodevelopmental Disorders in Children With Systemic Inflammatory Disease

Systemic inflammatory diseases in children include autoinflammatory diseases (deregulation of the innate immune system with production of pro-inflammatory cytokines) and autoimmune diseases (deregulation of the adaptive immune system with production of pathogenic autoantibodies). Neurological damage has been reported in both cases, but the neurodevelopmental psychiatric manifestations are poorly known, especially in children. Neurodevelopmental disorders are a broad spectrum of pathologies that are underpinned by common symptomatic dimensions. They have a common physiopathology combining genetic predisposing factors as well as environmental risk factors, making it possible to study them from a global point of view. Among the environmental risk factors, the immune system seems to play an important role in the appearance of these pathologies. In recent years, fundamental and animal studies have pointed to an important role of the immune system at the cerebral level. Indeed, far from the old notion of ""immune privilege"", the innate or adaptive immune balance seems to have a fundamental role in the proper development and functioning of the brain. Consequently, any modification of the immune balance could then disrupt neurodevelopment. Indeed, in recent years epidemiological studies seem to indicate the role of immune-mediated events during pregnancy (maternal autoimmune/inflammatory pathology or infection during pregnancy) or the first years of life (autoimmune/inflammatory pathology) as risk factors for neurodevelopmental disorders. Neurodevelopmental manifestations are very poorly known in systemic inflammatory pathologies. They can have a significant impact and justify adapted care in order to limit the functional impact. The main objective of our study will be to define the prevalence of neurodevelopmental disorders in children with systemic inflammatory diseases.

Start: April 2021

No-worry Baby Project

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.

Start: November 2018

Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age

This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the PICU of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016. A link to a questionnaire including the Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment as well as question on current impairments and health, will be sent to parents. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided.

Start: September 2020

Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Pediatric Clinical Practice

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.

Start: July 2016

Strongest FamiliesTM Neurodevelopmental

Children and adolescents with neurodevelopmental conditions are 3 to 5 times more likely than their peers to have other mental disorders such as anxiety, depression and disruptive behaviour. Furthermore, these conditions are less likely to be recognized, diagnosed and treated than for typically developing children. Parent training is a well-established approach to help parents change their behaviour and communication with their children with the goal of improving child behaviours. Parent-focused programs that are designed for typically developing children have shown mixed results for children with neurodevelopmental conditions and parents have reported significant challenges in accessing traditional health services due to barriers to care. There is an urgent need to explore how effective distance-delivered parenting programs can be implemented in real-world settings and how they should be adapted to meet the needs of families with children with neurodevelopmental conditions. The goal of this research project is to develop and test the effectiveness of two versions (group coaching & self-managed) of an online parenting program for managing challenging behaviours in children with neurodevelopmental disabilities. The Strongest Families Neurodevelopmental program is based on the well-established Strongest Families Parenting program for typically developing children with challenging behaviours, adapted with substantial involvement from a pan-Canadian Parent Advisory Committee. The program consists of 11 skill-based sessions with demonstration videos, audio clips, exercises, a resource webpage and a Parent-to-Parent online group (a closed Facebook group).

Start: April 2019

Dance for Children With Neurodevelopmental Disorders

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, (5) social communication This study explores the impact of organized dance and creative movement classes on children with neurodevelopmental disorders (ages 4-17) 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.

Start: January 2021

Effect of Parental Peri-conceptional Vitamin B12 Supplementation on Infant Neurocognitive Development in Offspring

Maternal nutrition is an important factor which determines fetal growth and development. Micronutrients vitamin B12 and folic acid are essential determinants of one carbon metabolism and play an important role in DNA synthesis, methylation and epigenetic regulation of gene expression. Diabetes unit of KEMHRC, Pune has been conducting the Pune Rural Intervention in Young Adolescents since last 3 years. Subjects of the PMNS cohort have been randomized as part of a controlled trial of nutritional intervention with vitamin B12 vs multiple micronutrient and milk protein vs placebo. This study aims to understand the intergenerational effects of vitamin B12 supplementation. 74 infants have been born in this trial since 2013. This study would assess neurocognitive development of offspring born to mothers who are part of the nutritional intervention trial; on the Bayley scales of infant and toddler development - III. The study aims to test the hypothesis that infants born to mothers who received vitamin B12 would have favorable infant neurocognitive development scores as compared to placebo. And this effect would be enhanced in the group whose mothers received MMN with milk protein.

Start: May 2017