View clinical trials related to Autistic Disorder.
Filter by:Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by social impairment, repetitive behaviors, and narrow interests. With advancements in diagnostic techniques, the prevalence of ASD has been increasing annually. However, due to its complex and diverse etiology, there is no definitive consensus on the pathogenic mechanism of ASD. Numerous studies indicate that genetics, environment, and other factors play crucial roles in the onset of ASD. Vitamin A (VA) exerts its effects in the body through its active metabolite, retinoic acid (RA), which regulates the transcriptional activity and expression of downstream genes by binding to retinoic acid receptors (RARs/RXRs). Triggering Receptor Expressed on Myeloid Cells 2 (TREM2) is an immunoglobulin-like receptor present on microglial cells, with functions including inhibiting the production of inflammatory factors and engulfing apoptotic neurons. Recent foreign studies show a significant decrease in TREM2 levels in the brain tissue of ASD patients. However, there is limited research on the relationship between TREM2 and ASD. In our previous animal experiments, we observed a reduction in TREM2 in the prefrontal cortex of the brain in ASD model rats. Administering overexpressed TREM2 improved autism-like behavior in ASD model rats, and supplementing RA upregulated the expression of RA-RARα and TREM2, modulated microglial cell activation, and improved autism-like behavior in rats. Therefore, we believe that the RA/RARα pathway regulates the TREM-2 signaling pathway, mediating changes in microglial cells, and TREM2 may be involved in the pathogenesis of ASD. Soluble TREM2 (sTREM2) is formed by the extracellular domain shedding of TREM2 under the action of ADAM protease. Research indicates that the expression of sTREM2 can be detected in cerebrospinal fluid and plasma. However, the connection between VA, sTREM2 levels, and the behavioral and developmental levels of children with ASD remains unclear and requires further clinical research to validate. This will help deepen our understanding of TREM2 expression in ASD, its potential biological functions, and the role of RA.
In addition to the "core" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is estimated that up to 70% of autistic people present at least one comorbid psychiatric disorder, leading to a deterioration in quality of life, a greater demand for support and worse prognosis and outcome. Anxiety and depressive symptoms would seem to be more present in individuals with Level 1 ASD, requiring their prioritisation against core symptoms. To date, the first-line treatment for autistic patients with comorbid depressive and/or anxiety symptoms is still debated and it is not always clear whether they may or may not benefit from psychotherapeutic and conventional psychopharmacological approaches. As such, growing evidence strengthens the therapeutic potential of the endocannabinoid (eCB) system modulation and of eCB-like compounds. The aim of this study is to provide a response to an unmet clinical need in this framework of psychic vulnerability by initiating oral therapy with palmitoylethanolamide (PEA), a nutraceutical/food supplement with proven anti-inflammatory and neuroprotective properties. Indeed, many conditions of psychological distress are thought to be underpinned by systemic inflammatory and/or neuroinflammatory processes, on which PEA has shown remarkable efficacy, including through modulation of the immune response and the interaction between the endocannabinoid system and the gut-microbiota-brain axis. The trial we are proposing is a 12-week open-label phase 2 study involving the daily intake of PEA 600 mg, at a dosage of 1 tablet/day. This study will be conducted at the Unit of Psychiatry of Santa Maria della Misericordia Udine University Hospital. Through this study, we wish to evaluate: the ability of PEA to alleviate symptoms of psychic distress (i.e., anxiety and/or depression) in Level 1 autistic adults; the safety and tolerability of sustained intake of PEA in Level 1 autistic adults; and the biological basis of PEA functioning. The study involves taking PEA orally once daily (600 mg daily) at the same time as a meal during the initial 12-week phase. Upon completion of the initial phase, subjects will be offered to enter an extension phase of the trial of an additional 24 weeks to assess treatment stability, with the possibility of titration of PEA to 1200 mg daily based on observed clinical compensation. Each participant will be on PEA treatment for up to 36 weeks. During the course of the study, periodic clinical re-evaluations will be conducted at our Day-Hospital setting. The trial will unfold through one screening visit, one baseline visit, and two follow-up visits (FUP, 4 weeks and 12 weeks apart). The patient will be administered standardized interviews by a qualified investigating physician; clinical objective examination, collection of blood and urine samples for standard hematochemical investigations, collection of blood and stool samples for analysis of some biological markers of interest, monitoring of adherence to therapy intake, side effects, and adverse effects will also be performed during the follow-up visits. The nutraceutical PEA will be dispensed by the clinical investigators at each follow-up visit.
Autism spectrum disorder (ASD) is a complex neurological development with onset in infancy or early childhood. Atypical sensory processing has been widely reported in ASD, and recent literature suggest that this abnormality extends across the life span, with consequent important implications in every-day life of autistic individuals and their families. Multisensory environments have been used in children with ASD precisely as a function of this particular difference in sensory processing and some studies have highlighted potential benefits. Therefore, the aim of our study is to verify feasibility and efficacy of an integrated treatment program with the multisensory room compared to as usual treatment in patients with ASD.
The objective of the study is to learn about and manage emotions such as anxiety and anger. The activities are aimed at identifying and managing emotions such as anxiety and anger, through the recognition of the changes that occur at a physiological, cognitive, behavioral and communicative level. In the first sessions, children will be exposed to the emotion of happiness through pleasant activities and involved in relaxation exercises. In subsequent sessions, anger and then anxiety will be addressed first. Social tools will be introduced and ways of thinking and perspective useful to children will be addressed. Furthermore, they will learn to use all the tools and strategies necessary to face and overcome the various emotions and situations in a functional manner. In the final sessions, children will work to design a cognitive-behavioral intervention program for themselves and other group members to improve the management of anxiety and anger. The expected results concern the acquisition of adequate emotional regulation; the construction of functional thoughts, social tools, thinking and perspective tools, adequate strategies for managing emotions; the design of a cognitive-behavioral intervention program in daily life and the strengthening of relational, social, empathic and resilient skills within the peer group and families.
Food selectivity is a common challenge among children with Autism Spectrum Disorder (ASD), with significant impacts on their nutrition and well-being. The main purpose of this study is to promote children's active participation in mealtime routines and encourage experimentation with new foods through an approach that emphasizes joy and serenity during mealtimes. The study will involve children with ASD between the ages of 4 and 10 years, of both sexes. Food selectivity will be assessed through interviews with parents and the use of specially created cards. The protocol will include 45-minute sessions, twice a week, for a total of 48 sessions. During these sessions, two plates, a list of foods previously agreed upon with the parents, and the foods needed for each session will be used. The sessions will take place in an environment called "Home Lab"a specially set up as if it were a kitchen to reproduce a home atmosphere.
The project involves the participation of 40 children with Autism Spectrum Disorder of both sexes, aged between 6 and 10 years. The subjects will undergo a pre-intervention evaluation phase, which will consist of administering the Theory of Mind (ToM) test present in the NEuroPSYcology second edition (NEPSY) battery, part A. The same test will be administered again at the end of the intervention. Once the inclusion criteria have been met and following the randomization of the sample, divided into Experimental Group (EG n=20) and Control Group (CG n=20), the administration of the search task will proceed. The study involves 12 sessions, one per week, lasting 45 minutes. The EG will view twelve social scenes created through a tablet. In the scenario, the depictions will be presented in color. Guided by the narrating voice of QT Robot, they will have to choose between two or three alternatives the one that represents the appropriate mental state by selecting it on the tablet. Consequently, an audio-visual feedback will be provided, through the robot, to give the subject information about the accuracy of their response. In both groups, a simple instruction will be given to the child, telling them to pay attention to the story that will be narrated and then answer simple questions. In the EG, QT robot will speak, while in the CG it will be the operator. The prompts will be related to the accuracy of the response or they will rather be aimed at encouraging the child to give the correct answer.
Evaluation and follow-up of children diagnosed with an autism spectrum disorder in French-speaking Belgium in order to optimize diagnostic protocols, the quality of care required and its accessibility, and to determine the impact of an autism spectrum disorder on schooling, family and society.
The goal of this interventional study was to examine the effectiveness and mechanism of online peer companion intervention (OPCI) on the social abilities and mental health of ASD children. The main questions it aims to answer are: 1. Whether OPCI is effective on the social abilities and mental health of ASD children; 2. What impact does OPCI have on the social abilities and mental health of ordinary children; 3. What impact does OPCI have on the mental health of both children's parents; 4. What are the mechanisms of OPCI on ASD children.
Autism Spectrum Condition (ASC) is a behavioral syndrome characterized by a severe organizational disorder of thinking and major functions that regulate human adaptation. It is to be considered as a functional disorder, or of executive functions, whose dysfunction is expressed in the difficulty of making voluntary movements, sequentially coordinated with each other according to a purpose, and of initiating an action, planning and monitoring it by inhibiting inappropriate responses such as gesture perseveration. Literature studies suggest that, compared to children with typical development (TD) and regardless of cognitive status, children with ASC have pervasive motor dysfunction that results in universal difficulties in several aspects of motor function, including - (1) fine motricity, (2) some aspects of praxis while performing tasks based on imitation of sequences, (3) simultaneous coordination of both sides of the body during rhythmic tasks of the upper limbs, and́ (4) interpersonal coordination and synchrony. The hypothesis of the study is that by comparing these aspects in 2 groups of children with ASC and children with TD using A.I. systems, it will be possible to extract objective markers of motor deficits found in autism, facilitating the validation of measurements acquired with clinical scales. The objective of the study is to investigate the characteristics of manual motor planning and performance difficulties in children with ASC using kinematic measurements. 30 ASC children with medium-high functioning and 30 TD children, aged 7 to 13 years, IQ > 80, in the absence of motor deficits due to another clinical condition, will be recruited. The protocol will take place in a single session during which children will be video-recorded performing simple and complex rhythmic upper limb actions with a social partner. The presence of characteristic fine motor behaviors, practice errors, perseverations, movement variability, and interpersonal synchrony will be observed. The study will involve the use of 3 tasks contained in NEPSY-II: Finger tapping, Visual-motor precision, and Imitation of manual motor sequences. The videos will be recorded simultaneously and the different angles will allow hand kinematics to be extracted and analyzed with A.I. algorithms to measure displacement, velocity, acceleration, frequency and any other kinematic parameters highlighted. Thus, it is expected to identify objective markers of motor deficits found in children with ASC.
This study will assess clinical and behavioral measures along with electroencephalogram (EEG), event-related potentials (ERPS), and eye-tracking (ET) prior to and following a single intermittent Theta Burst Stimulation (iTBS) session to provide preliminary insight into the potential of TMS as an intervention for depression in individuals with Autism Spectrum Disorder (ASD).