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Autistic Disorder clinical trials

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NCT ID: NCT02586935 Completed - Clinical trials for Autism Spectrum Disorders

Tideglusib vs. Placebo in the Treatment of Adolescents With Autism Spectrum Disorders

TIDE
Start date: February 10, 2016
Phase: Phase 2
Study type: Interventional

This study will examine the safety and efficacy of tideglusib vs. placebo for the treatment of core symptom domains in adolescents with Autism Spectrum Disorders

NCT ID: NCT02584972 Completed - Clinical trials for Autism Spectrum Disorder

Postural Control During Walking and Standing Among Children With Autism Spectrum Disorder

PCASD
Start date: November 2015
Phase:
Study type: Observational

Lately, many researchers have found that Children with autism spectrum disorder (ASD) are most likely to have gross motor deficiencies such as lack of coordination in gait and balance. Much has been researched on etiology and motor learning, but only very few researches have examined and analyzed quantitatively gait and balance in ASD. The aim of this research is to analyze quantitatively balance, gait and balance during perturbation in children with ASD and to compare with typically developed children (TD). A group of 20 children diagnosed with ASD and a control group of 20 TD children will be recruited and tested in the laboratory with well-established measures of gait and balance function. They will be instructed to stand as still as possible on a force plate with different task conditions : (1) standing with the eyes open (EO) - standing upright viewing an "X" displayed on a screen 3 meters in front of them; (2) eyes closed (EC) - same as (1) with the eyes closed and covered by blindfolds (i.e. no visual information). (3) Same as 1 standing on foam (i.e., conflicting proprioceptive information). Gait will be measured using the narrow base walk test, modified for clinical use. Participants will be asked to walk within a narrow path 6 meters long . The statistical analysis will include Independent T-tests to compare the ASD and controls with respect to different characteristics. General Linear Model (GLM) will be used by applying a separate model where the dependent variables will be the average values of the postural stability or gait stability parameters (continuous) and the independent variables were categorical by the group and task condition.

NCT ID: NCT02579109 Completed - Autism Clinical Trials

Multisensorial Information's Treatment in Autism Spectrum Disorder

Start date: February 2014
Phase: N/A
Study type: Interventional

Introduction: Autism spectrum disorder is characterized by deficits in three functional domains: language and communication, social reciprocity, and the presence of restricted interests/repetitive behaviors. There's also deficits in social cognition. When having a face-to-face conversation, a listener not only hears what a speaker is saying, but also sees the articulatory gestures that accompany those sounds. Speech signals needs then a multisensory processing. Impairments in multisensory perceptual binding may be particularly relevant in ASD, given that hallmark features of the disorder include difficulties in speech, communication, and social interactions. Objectives: The investigator suggest that atypical multisensory processing in ASD may have an impact on speech perception and social processing. Aims: Methods: This pilot study measures free recall scores in 3 lists of words presentation after 30 minutes. In the first condition (CI) words are only listening. In the second condition (CII) words are associated with a picture of a mans face. In the third condition (CIII) words are associated with a video of a man speaking. Three lists are homogeneous form words characteristics (lexical frequency, emotional valence norm, imageability). Participants were 7- to 13-year-olds typically developing children (TD) (N = 19) and ASD children (N = 19). The investigator would create some new tools for exploring the treatment of a social information. These tools should be the closest of a ecological social interaction.

NCT ID: NCT02574273 Completed - Anxiety Clinical Trials

Pilot Trial of a Social Skills Group Treatment (Secret Agent Society Program)

Start date: October 2015
Phase: N/A
Study type: Interventional

Several independent evaluations have supported the effectiveness of the Secret Agent Society (SAS) Program in improving the social-emotional functioning of children with Autism Spectrum Disorders (ASD) in clinic- (Beaumont & Sofronoff, 2008; Tan, Mazzucchelli & Beaumont, submitted), school-(Beaumont, Rotolone & Sofronoff, in press; Einfeld et al., submitted) and remote Skype/telephone-assisted delivery contexts (Sofronoff, Silva & Beaumont, in press).The present study aims to extend on the above literature by conducting a 6-month randomized controlled trial evaluating the effectiveness, utility and acceptability (including cultural acceptability) of the Secret Agent Society (SAS) social-emotional skills training program. Specifically, the study aims to evaluate the effectiveness of the SAS Program for 8-12 year-old children with social difficulties in the context of a range of diagnosed mental health conditions and/or developmental disorders, including anxiety disorders, ADHD, and Autism Spectrum Disorder.

NCT ID: NCT02573428 Completed - Clinical trials for Autism Spectrum Disorders

Evaluating the Validity of an Eye Gaze Paradigm in Predicting Autism Spectrum Disorder

EYE
Start date: June 2015
Phase: N/A
Study type: Observational

The primary purpose of the present study is to evaluate the diagnostic validity of eye tracking measurements acquired during viewing of socially-relevant stimuli in predicting ASD diagnosis. The secondary purpose was to explore the potential prognostic value of eye tracking measures through cross-sectional associations with non-verbal cognitive ability. Deficits in eye gaze are a hallmark sign of autism. A large and growing body of research supports the ability of eye-tracking based measurements to sensitively discriminate individuals with ASD and healthy participants. These investigations have identified that the core deficit in autism as disruption of social attention, reflecting an inability to appropriately engage and track socially- and emotionally-relevant aspects of the visual world. Thus, eye gaze tracking, acquired during viewing of socially-relevant stimuli, may be a useful approach to identifying objective markers of ASD. Eye tracking also carries the advantages of being less intrusive and expensive than MRI and genetic testing and specifically focuses on the core neurobehavioral characteristics of ASD - abnormalities in social attention. After diagnosis of ASD, key clinical tasks in young children involve determining an accurate prognosis and tracking the progress of early interventions. Currently, the only prognostic indicators are clinical observations (subjective and expensive) and non-verbal cognitive ability testing (difficult to acquire, time-consuming, unavailable in many settings). Recently, eye gaze tracking was found to predict functional outcomes. Thus, in addition to being an objective marker for ASD, eye tracking measurements have potential to be useful for predicting cognitive and functional outcomes. Similarly, the only available methods for tracking treatment progress are parental reports (highly subjective), clinical observations (subjective and expensive), and cognitive measurements (expensive and unavailable in many settings. This study will evaluate, using cross-section data, the potential for eye tracking data to serve as a proxy for non-verbal cognitive ability scores in determining prognosis for ASD-affected children. Additionally, this study will evaluate the test re-test reliability of eye tracking parameters that can potentially be used to track treatment progress.

NCT ID: NCT02568631 Completed - Autistic Disorder Clinical Trials

Improving Social Cognition for Adults With ASD by the Serious Game JeStiMulE Versus Controls

Start date: September 22, 2015
Phase: N/A
Study type: Interventional

The serious game "JeStiMulE" (Educational Game for Multisensory Stimulation of Children with developmental disorders), developed by the Autism Resources Center of Nice, was created to teach social cognition including emotion recognition in context, for children and adolescents with autism. In a previous study, JeStiMulE has demonstrated efficacy in a population of young people aged 6-17 years old with high and low levels of autism. According to the recommendations of the 2011 HAS, disorders of social interactions are the most persistent troubles of the autistic triad in life. It seems essential to us to be able to offer young adults with autism, rehabilitation methods adapted to their trouble, and to observe whether JeStiMulE could be one of them. This study researches the effectiveness of the serious game JeStiMulE in the improvement social cognition for adults with autism versus controls. The main goal is: - Comparing the improvement in social cognition among adults with autism using the serious game JeStiMulE or not. Two groups will be formed: a first one of fifteen adults with a diagnosis of autism objectified, this group will use JeStiMulE and will be compared to a control group of adults with autism, using another video game, not aimed to improve social cognition. The objective of JeStiMulE players will be ending the game after a learning period and two playing periods (with emotional words and idioms, including three modules each). The groups will be matched with their nonverbal IQ through Raven matrices and visual memory tasks (WAIS). The control group will also be stimulated through a video game, not specialized in improving social cognition. The primary outcome will be assessed by the emotion recognition at the FEEST of Ekman test: by the number of emotions recognized on faces, compared to the number of emotion presented through this test. The secondary outcomes will be: - The rest of social cognition improvement by several tests (the theory of mind with the score of the Tom-15, the intention with the score Sarfati cartoons, empathy with a self-administered questionnaire: EQ / AQ). - The impact on the quality of life, verbal fluency of emotional words, and the feedback from JeStiMulE players will also be seen as a secondary outcome.

NCT ID: NCT02561481 Completed - Clinical trials for Autism Spectrum Disorder

Sulforaphane Treatment of Children With Autism Spectrum Disorder (ASD)

Start date: December 2015
Phase: Phase 1/Phase 2
Study type: Interventional

ASD is a diverse disorder starting in early childhood and characterized by social communication impairment as well as restricted interests and repetitive behaviors. It affects 1:68 children and is an enormous medical and economic problem for which there is no established, mechanism-based treatment. Sulforaphane is an isothiocyanate derived from broccoli, and has potent activity in transcriptionally up-regulating genes that control mechanisms whereby aerobic cells protect themselves against oxidative stress, mitochondrial dysfunction, and inflammation. This study is a clinical trial of oral sulforaphane (as broccoli seed powder) in 50 boys and girls (3-12 years) with ASD in 3 phases over 36 weeks. In Phase 1, 25 children will receive active drug and 25 will receive placebo for 15 weeks; in Phase 2, all children will receive sulforaphane from 15-30 weeks; in Phase 3, children will receive no treatment for 6 weeks. Study visits will take place at screening, 7, 15, 22, 30 and 36 weeks, when the Ohio Autism Clinical Clinical Impressions Scale - Severity and Improvement (OACIS-S and OACIS-I), Aberrant Behavior Checklist (ABC) and Social Responsiveness Scale (SRS) will be recorded. Children will be monitored with physical examinations and for toxicity with clinical laboratory studies and examine possible biomarkers: Nuclear factor-erythroid factor 2 (Nrf2), oxidative stress and mitochondrial function, the mechanistic target of rapamycin (mTOR) pathway and cytokine expression. In addition, prior to the main clinical trial, a pilot study will be carried out in 10 children with ASD, 6-12 years of age, who will receive sulforaphane, 2.2 micromoles/kg daily for 14 days. Blood and urine samples before and at the end of treatment will be collected, in order to measure several parameters that are likely to demonstrate expected effects of sulforaphane, to standardize the assays and procedures, and to determine the most effective measures.

NCT ID: NCT02560415 Completed - Clinical trials for Autism Spectrum Disorder

Gaming Open Library for Intervention in Autism at Home (GOLIAH /MICHELANGELO)

MICHELANGELO
Start date: September 2014
Phase: N/A
Study type: Interventional

To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH). The major objective of the study is to test GOLIAH during a 6-month matched controlled exploratory study were to assess (1) the usefulness and acceptability of the gaming platform; (2) how experimental children performed using the different Imitation and JA games; and (3) whether children from the experimental group improved significantly more than children treated as usual (control group).

NCT ID: NCT02552147 Completed - Clinical trials for Autism Spectrum Disorder

Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism

Start date: September 2015
Phase: Phase 1
Study type: Interventional

Some individuals with autism spectrum disorders (ASD) also demonstrate irritability or aggression, which can interfere with functioning. The purpose of this pilot study is to test whether transdermal nicotine is effective for irritability and/or aggression in adults with ASD using a double-blind, placebo-controlled clinical trial. Subjects will participate in three visits. At the first visit, subjects are screened for eligibility and enrolled. Baseline measures include rating scales and a frustrative computerized task. They will then wear seven days of transdermal nicotine or placebo. Visit two is on day seven and the study measures are repeated, vital signs and side effects monitored. Subjects will return for a third and final visit on day 21 to repeat the study measures performed during visit two.

NCT ID: NCT02536365 Completed - Autism Clinical Trials

Sensory Integration Therapy in Autism: Mechanisms and Effectiveness

Start date: September 2015
Phase: N/A
Study type: Interventional

A common feature of ASD is over or under sensitivity to the environment and difficulty putting sensory information together in an orderly way, referred to here as sensory issues. Building on previous work, this study will test the efficacy of Sensory Integration Therapy (SIT), a non-invasive intervention to improve functional skills in children with ASD, in comparison to commonly applied ABA behavioral treatments, in the treatment of ASD symptoms. A total of 180 children with ASD and sensory issues in the greater New York City Metropolitan area will complete this study.