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NCT ID: NCT04119492 Recruiting - Clinical trials for Autism Spectrum Disorder

DCD & ASD Imaging Intervention Study

Start date: February 20, 2019
Phase: N/A
Study type: Interventional

Developmental Coordination Disorder (DCD) is a neurodevelopmental disorder that affects a child's ability to learn motor skills, such as tying shoelaces, learning to print, or riding a bicycle (APA 2013). It often co-occurs with other conditions, such as Attention Deficit Hyperactivity Disorder (ADHD). Its high co-occurrence with Autism Spectrum Disorder (ASD) has only been permitted since 2013 so it is less well known. Recent neuroimaging studies have begun to unravel the neural underpinnings of each disorder; however, few brain imaging studies have included children with co-occurring DCD and ASD. The first aim of the proposed project is to understand brain structure and function in children with DCD+/-ASD. Despite high co-occurrence of DCD and ASD (Green 2009), motor impairment and functional problems are rarely the focus of therapy for children with ASD. Current best-practice for improving motor function is an approach called Cognitive Orientation to Occupational Performance (CO-OP). The second aim of this study is to examine effectiveness of this treatment approach for children with DCD+ASD and determine if there are brain changes and improvements in motor skills as a result of intervention. This novel project is the first to integrate brain imaging and motor-based rehabilitation in this population and builds on a current study examining brain changes in children with DCD (with and without co-occurring ADHD). Examining the neural basis of these motor difficulties in the presence or absence of co-occurring conditions will help to determine the neural correlates specific to DCD and whether the response to treatment differs in children with co-occurring conditions.

NCT ID: NCT04118647 Recruiting - Clinical trials for Gastroesophageal Reflux Disorder

Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder

Start date: October 2019
Phase: Phase 4
Study type: Interventional

Gastroesophageal reflux disorder (GERD) is due to gastric content reflux to esophagus cause symptom and complication including intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. Because the changes of dietary habit, and improvement of examination skill and data analysis, the prevalence of GERD increased 2.5 multiple from 1995 to 2002, and suggesting the prevalence is 25% in Taiwan community. The etiology of GERD is multi-effect, such as transient lower esophageal sphincter relaxation and abnormal pressure of lower esophageal sphincter, which may induced the esophageal mucosal injury by gastric acid, bile or pancreases enzyme. Wu-Chu-Yu tang consists of Evodia fargesii Dode (Evodia Fruit), Panax ginseng C. (Ginseng), Ziziphus jujube Mill (Chinses Date), Zingiber officinale Rosee (Fresh Ginger).According to "I-Fang-Chi-Chieh" and "Shanghonzobinglun" recordings that Wu-Chu-Yu tang can treat vomiting, and also can relax gastric tonicity and can enhance peristalsis of stomach. According to Randomized, double blind, placebo control trial to evaluate the efficacy of Wu-Chu-Yu Tang on gastroesophageal reflux disease, we know the Wu-Chu-Yu tang have the equivalent effect proton pump inhibitor omeprazole. But, the mechanism of Wu-Chu-Yu tang is still unknown.

NCT ID: NCT04100863 Recruiting - Clinical trials for Autism Spectrum Disorder

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism

Start date: March 2, 2020
Phase:
Study type: Observational [Patient Registry]

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.

NCT ID: NCT04093518 Recruiting - Schizophrenia Clinical Trials

Estradiol as add-on to Antipsychotics

EST-S-02
Start date: December 2, 2019
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the efficacy of Estradiol patch compared to placebo, as add-on to anti-psychotics in the treatment of women 38 and older with schizophrenia, schizoaffective or schizophreniform disorder.

NCT ID: NCT04080258 Recruiting - Headache Disorders Clinical Trials

Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.

Start date: June 18, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effectiveness of osteopathic manipulative therapy, in supporting prophylactic medications in paediatric patients, with high frequency headache.

NCT ID: NCT04072510 Recruiting - Eating Disorders Clinical Trials

Evaluation of Self-esteem Group Therapy for Eating Disorders

Start date: October 22, 2018
Phase: N/A
Study type: Interventional

Self-esteem group is a novel, manualised group programme designed for adolescent inpatients with eating disorders. Research questions: Does the self-esteem group improve self-esteem in adolescent inpatients with eating disorders? Are any changes in self-esteem maintained at 4 week follow-up after the group? Does eating disorder psychopathology improve more during admission for those who complete the self-esteem group compared to those who do not complete the group? Background: Low self-esteem has been established as a strong predictor of onset, maintenance and relapse in eating disorders. For patients with low self-esteem, change can be particularly difficult to achieve. The intensity of their low self-esteem leads them to strive to control their eating, weight and shape to gain a sense of self-worth and the pervasive negative view of themselves results in them seeing little or no prospect of recovery. This suggests treatment of low self-esteem is clinically and financially important. Studies have shown cognitive behavioural based group therapies improve self esteem in adults with eating disorders; however research including adolescents is limited. This research will contribute to the evidence base for self-esteem interventions in adolescents and inform the effectiveness of a new treatment. The research will be funded by Newbridge House, an inpatient unit for children and adolescents with eating disorders. Design: Inpatients at Newbridge House aged 11 - 18, fulfilling DSM-V criteria for an eating disorder will be recruited.Participants will be randomly allocated to a case or control group. Cases will receive the 6 week self-esteem group in addition to treatment as usual (TAU) and will be compared with controls who receive TAU. Both groups will complete a questionnaire pre-group, post-group and 4 weeks post-group. Admission and discharge questionnaires routinely collected will be examined to assess change in eating disorder psychopathology.

NCT ID: NCT04071899 Recruiting - Clinical trials for REM Sleep Behavior Disorder

French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)

SEV-TCSP
Start date: May 24, 2019
Phase:
Study type: Observational

REM (Rapid Eye Movements) Sleep Behavior Disorder (RBD) is a parasomnia characterized by episodes of elaborate or violent motor activity during dreams, which can lead to injury and sleep disruption in patient and / or his/her spouse. This is due to the loss of the normal muscle atonia during REM Sleep. RBD is often associated to neurodegenerative diseases, and may even precede them for several years as an early marker. Currently, there is no scale or tool for assessing the severity of RBD. Nevertheless, it is crucial to have a tool of severity when one wants to study the natural evolution of this disorder, as well as the possible effect of a drug in the context of a clinical trial. A Severity Scale of RBD has recently been proposed within the International RBD Study Group and an international validation study in several languages is being considered. The main objective of this study is to validate a new scale of severity of the REM sleep behavior disorder (RBD Severity Scale or RBDSS) and to characterize its metrological properties, in particular its concurrent validity, internal consistency and reproducibility

NCT ID: NCT04066985 Recruiting - Depression Clinical Trials

Targeting Adolescent Depressive Symptoms Via Brief, Web-Based Interventions

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality. The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, <50% of youth with MD access treatment. Thus, a need exists for interventions that are feasible for youths and parents to access and complete—and that may strengthen parents' likelihood of pursuing longer-term services. Single-session interventions (SSIs) may help forward these goals. SSIs include elements of comprehensive treatments, but their brevity makes them easier to disseminate at scale. Meta-analytic evidence suggests SSIs can reduce youth psychopathology, including self-administered (e.g., online) SSIs. One computer-based SSI, teaching growth mindset (GM; viewing personal traits as malleable), has reduced adolescent depressive symptoms in multiple RCTs. A second computer-based SSI was recently developed to reduce youth depressive symptoms via targeting reductions in self-hate—a symptom identified as important for the maintenance of other depressive symptoms in teenagers. This study will test whether either the growth mindset SSI (GM-SSI), the self-kindness SSI (SK-SSI), or both SSIs reduce symptoms of depression in adolescents, relative to an active "supportive therapy" SSI, which teaches adolescents to share their emotions with trusted others. Youths participating in existing research through the Healthy Brain Network (N=501) will receive either the growth mindset SSI (GM-SSI), the self-kindness SSI (SK-SSI), or the supportive therapy SSI (ST-SSI). The investigators will examine whether the GM-SSI and/or the SK-SSI, versus the ST-SSI will reduce youth depressive symptoms across three months. Results may identify two novel, potent, and brief interventions for adolescent depressive symptoms.

NCT ID: NCT04065906 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder (ADHD)

Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

To observe the clinical efficacy and mechanism of functional near-infrared spectroscopy imaging neurofeedback therapy for attention deficit and hyperactivity disorder.

NCT ID: NCT04065386 Recruiting - Clinical trials for Minimally Conscious State

Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Consciousness

Start date: February 9, 2022
Phase: N/A
Study type: Interventional

Non-invasive brain stimulations techniques have recently shown promising results in patients with disorders of consciousness. Notably, a case reported improvement of level of consciousness using transcutaneous auricular vagal nerve stimulation in a patient in unresponsive wakefulness syndrome. Here we aim to assess the effects of transcutaneous auricular vagal nerve stimulation on post-coma patients with disorders of consciousness in a first randomized controlled trial. To measure these effects, behavioral (Coma recovery scale revised - CRS-R -primary outcome) and neuro-electrophysiological (electroencephalography - EEG - secondary outcome) data will be recorded in severely brain-injured patients with DOC.