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Found 31 Actively Recruiting clinical trials

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Researchers are studying the brain-to-brain connection between mothers and their infants born very preterm (VPT) compared to full-term (FT) infants. This study focuses on how early sensory stress and separation during Neonatal Intensive Care Unit (NICU) stays may affect neurodevelopment and parent-infant interaction. It aims to compare brain co-regulation patterns between FT and VPT mother-infant pairs and examine how an early parenting video-feedback (VF) intervention after hospital discharge might improve brain-to-brain synchrony in VPT dyads. The trial is a randomized controlled study with three groups: FT dyads, VPT dyads receiving the VF intervention, and VPT dyads receiving usual care. The VF intervention includes 8 weekly remote sessions over about two months after NICU discharge. These sessions help mothers understand and respond to their infants' behaviors through shared video feedback and guided play. The intervention focuses on sensory, behavioral, cognitive, and emotional aspects of parenting to support infant development and parent-infant closeness. Participants will complete questionnaires on maternal well-being, parenting stress, bonding, and infant development at 3, 6, and 9 months corrected age. At 9 months corrected age, mother-infant pairs will participate in a 5-minute EEG hyperscanning task to measure brain-to-brain co-regulation using Phase-Locking Value, Amplitude-Amplitude Coupling, and Imaginary Coherence. Researchers will analyze these brain synchrony indexes to understand their role in the effects of the VF intervention and to predict developmental outcomes.

Age: 0 - 3MonthsAll GendersPhase Not Applicable
2 locations
A

Actively Recruiting

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.

Age: 7Years - 16YearsAll GendersPhase Not Applicable
3 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating how physiological signals and movement data can help understand and predict engagement with rehabilitation in children with neuromotor impairments. The study involves 40 children aged 5 to 17 years, including both neurotypical children and those with neuromotor impairments. The goal is to learn how engagement with therapy can be measured and improved to provide more personalized care. Participants will be divided into two groups: a control group of neurotypical children who will attend one rehabilitation session, and a group of children with neuromotor impairments who will take part in two to three rehabilitation sessions as part of their ongoing treatment plans. During these sessions, children will use either the Lokomat, a robotic exoskeleton that supports walking, or the GRAIL system, a treadmill with motion tracking and extended reality. Throughout each session, researchers will collect various data including heart activity (ECG), heart rate variability, electrodermal activity, movement data, exergame scores, motor performance, and therapist questionnaires assessing engagement. This information will help therapists adjust rehabilitation in real time, aiming to improve therapy effectiveness. The primary outcome measure is the Pediatric Rehabilitation Intervention Measure of Engagement observed at baseline.

Age: 5Years - 17YearsAll Genders
1 location
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Actively Recruiting

Antipsychotic drugs can cause changes in gene activity in blood cells before blood chemistry changes appear. This pilot study explores the gene activity profiles in children and adolescents aged 5 to 17 who are treated with antipsychotics and have metabolic disorders. It compares these profiles with those of similar patients who either use antipsychotics without metabolic disorders or have metabolic disorders but do not use antipsychotics. The goal is to identify transcript patterns that might serve as early markers to predict metabolic risks from antipsychotic treatment, helping to personalize therapy and reduce side effects. Participants are grouped into three categories: those using antipsychotics with metabolic disorders, those using antipsychotics without metabolic disorders, and those with metabolic disorders who do not use antipsychotics. The study involves a transcriptomic investigation, which analyzes gene activity in blood cells and classifies the findings based on biological function. Antipsychotic use is defined as daily use for at least three months before joining the study. Metabolic disorders are identified by criteria such as elevated body mass index, waist circumference, blood pressure, blood glucose, triglycerides, or low cholesterol. During the study, participants will have their gene activity measured once at recruitment alongside body mass index adjusted for age, sex, and height (BMI-Z). Researchers will collect blood samples to perform the transcriptomic analysis and assess metabolic status. This information will help evaluate differences between the groups and investigate potential early biomarkers for metabolic side effects related to antipsychotic use. The study aims to improve treatment management for children and adolescents with neurodevelopmental disorders and irritability.

Age: 5Years - 17YearsAll Genders
1 location
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Actively Recruiting

Researchers are investigating how pharmacological and psychotherapeutic group treatments affect children and adolescents aged 8 to 15 years with symptoms of ADHD, emotional-behavioral dysregulation, and externalizing disorders. The study aims to determine the effectiveness of these treatments on clinical symptoms and emotional-behavioral regulation, and to explore associations between individual characteristics and treatment responses using behavioral and neural data. This research is conducted through a multicenter, non-profit, prospective and retrospective interventional study design without randomization or blinding. Participants will receive either pharmacological treatment with methylphenidate or group psychological treatment based on clinical practice and national guidelines. The psychological group treatment involves 16 weekly sessions of 1.5 hours each over four months, with groups formed by age and skills (8-11 and 12-15 years). Pharmacological treatment includes a test dose followed by a dose adjusted from 5 to 20 mg per day, tailored by a child neuropsychiatrist according to treatment response and tolerability. A control group on the treatment waiting list will undergo the same assessments without receiving treatment. Participants will undergo multimodal assessments before treatment, including clinical and socio-demographic questionnaires, standardized computerized neuropsychological tests, and neurophysiological measures such as near-infrared spectroscopy (NIRS), electroencephalogram (EEG), and physiological data collected via a Samsung Galaxy Watch5 smartwatch during attention tasks. Follow-ups occur at treatment start, end of treatment or titration phase, and six months later to evaluate changes. Researchers will measure clinical severity using the Clinical Global Impressions - Severity Scale and track behavioral, neuropsychological, and neurophysiological changes over time.

Age: 8Years - 15YearsAll Genders
1 location
A

Actively Recruiting

Healthy Volunteer

Spatial navigation skills are crucial for daily life and quality of life, yet they are not commonly assessed or rehabilitated in patients. Children with cerebral palsy often have difficulties with visuo-spatial skills. This research aims to evaluate and compare the spatial navigation abilities of typically developing children and children with cerebral palsy using a virtual reality application called "StarMaze" delivered through a Head Mounted Display (HMD). Additionally, the study will explore participants' user experience during the session. Previous similar applications required large, costly setups, but this study uses affordable and accessible HMD technology to open new possibilities for assessing and potentially training navigation skills. Participants undergo a baseline assessment including cognitive testing and pen-and-paper tests for visuo-spatial abilities. Then, they perform a spatial navigation task using the Oculus Quest viewer with the StarMaze application, which involves navigating a 5-way star-shaped maze to find a hidden treasure. The application measures how well participants learn spatial information and the navigation strategy they use, such as egocentric or allocentric. After completing the session, participants fill out questionnaires about their experience, including any cyber-sickness symptoms and the usability of the application. During the study, researchers assess navigation skills and strategies over one day using the virtual reality task. Participants are monitored for cognitive ability and visual function to ensure suitability. The study focuses on understanding spatial navigation differences between children with cerebral palsy and typically developing peers, as well as gathering feedback on the virtual reality experience. This approach offers a shorter, accessible method for evaluating navigation that could inform future rehabilitation efforts.

Age: 13Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers aim to understand whether sensorimotor skills serve as specific biomarkers linking biological factors and behavioral traits in autism. This study addresses how early motor and sensory differences develop, how family relationships influence these abilities, and how these differences can help reveal the biological mechanisms of autism. The research includes infant siblings of autistic children, autistic children and their parents, and comparisons with typically developing individuals and their families. Participants undergo several evaluations including clinical assessments using the Autism Diagnostic Observation Schedule and Social Responsiveness Scale. Motor skills are measured through tools like the Movement Assessment Battery for Children 3, Developmental Coordination Disorder Questionnaire, Adult Developmental Coordination Disorder/Dyspraxia Checklist, and kinematic analysis of upper-limb movements during two motor tasks involving ball manipulation. Neurophysiological evaluation includes structural MRI and spectroscopy, and genetic evaluation involves DNA collection from blood or saliva to analyze genetic variants. During the study, researchers assess sensorimotor abilities, social characteristics, and biological data through these clinical, neuropsychological, neurophysiological, and genetic tests. Motor task performance and questionnaire results are measured immediately after interventions. The study includes children aged 2 to 12 years, parents of enrolled children, and infants under 24 months with a first-degree relative diagnosed with autism. The study is designed to explore multiple dimensions across behavioral, neural, and molecular levels for a comprehensive understanding.

Age: 1Year +All GendersPhase Not Applicable
1 location
C

Actively Recruiting

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.

Age: 5Years - 17YearsAll GendersPhase Not Applicable
6 locations
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Actively Recruiting

Healthy Volunteer

Researchers are studying the brain mechanisms involved in spatial navigation skills in children and adolescents aged 8 to 17 years. These skills help people orient themselves, find objects, interact with them, and remember their locations. The study compares typically developing children with those who have cerebral palsy (CP) to better understand differences in navigation abilities and how CP affects these skills. The goal is to improve knowledge of CP and support the development of better rehabilitation methods in the future. Participants will undergo a preliminary assessment that includes cognitive testing using the Raven test and evaluation of spatial navigation skills with the Corsi test and the maze sub-test of the WISC-III. They will also complete a navigation task in an immersive virtual reality environment while wearing an EEG cap to record brain activity. During this task, participants navigate a five-way maze to find a treasure, completing up to 30 trials lasting a maximum of 120 seconds each. Throughout the study, participants will be evaluated using EEG to measure brain activity and tests to assess navigation performance. The researchers will analyze power spectral density and navigation outcomes from the virtual reality task. The study involves a single assessment period where data on brain function and navigation skills are collected to better understand spatial navigation in both typically developing children and those with CP.

Age: 8Years - 17YearsAll GendersPhase Not Applicable
2 locations
C

Actively Recruiting

Healthy Volunteer

This research aims to explore how infants process spoken language early in life by studying brain activity related to speech tracking. It focuses on infants around 8 months old and compares those with and without a family history of language and learning difficulties. The goal is to see if early brain responses can predict language skills at 18 months, including both understanding and speaking abilities. At about 8 months, infants will undergo non-invasive brain recordings using EEG while listening to recorded speech and matched non-speech sounds. They will also have behavioral assessments using standardized developmental scales. Later, around 18 months of age, follow-up tests will measure their language comprehension and production. Additional background information about family history and demographics will be collected to understand influences on language development. Participants will be involved in two main assessments: the first at 8 months including brain recordings and developmental testing, and the second around 18 months focusing on language abilities. Researchers will track early neural markers and later language outcomes. The study uses safe, non-invasive methods and does not require active responses from the infants during brain recordings.

Age: 30Weeks - 34WeeksAll Genders
1 location

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Clinical trial studies in Bosisio Parini | DecenTrialz