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Executive Function clinical trials

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NCT ID: NCT06286943 Not yet recruiting - Executive Function Clinical Trials

The Effects of Short-Chain Fatty Acids in Psychosocial Stress-Induced Impairment on Core Executive Functions

GUTSIE
Start date: March 2024
Phase: N/A
Study type: Interventional

The aim of the present trial is to examine core executive functions (EFs) as a functional outcome of attenuating the cortisol response to acute laboratory stress through colonic delivery of an Short Chain Fatty Acids (SCFAs) mix (acetate, propionate, butyrate). A triple-blind randomized placebo-controlled parallel group trial will be conducted to compare the effects of SCFAs vs. placebo on core EFs (working memory [WM], cognitive flexibility [CF], response inhibition [RI]) under stress vs. no-stress conditions, after one week of SCFA vs. placebo treatment. First, the effects of SCFAs on stress-induced changes in core executive functions, with WM as the primary outcome, and CF and RI as secondary outcomes will be tested. Second, interindividual differences in microbiota composition (particularly abundance of SCFA-producers), saliva cortisol and serum SCFA levels will be explored to assess whether they are associated with interindividual differences in core EFs at baseline or following acute stress. Each participant will undergo 2 study visits: one will involve a stress condition and the other will involve a no-stress condition. Each study visit is preceded by a 1-week intervention or placebo period and separated by a 3-4 week washout period. To induce stress, participants will perform the Maastricht Acute Stress Task (MAST) or sham MAST as the control condition. To assess EF performance, three cognitive tasks will be performed 15 minutes after task offset: n-back task for WM; Stop Signal Task for RI; and Wisconsin Card Sorting Test for CF. Saliva samples will be collected before, during and after the (sham) MAST to assess the cortisol response. Blood samples will be collected throughout all study visits to quantify serum SCFAs, inflammatory markers and ACTH. Additionally, cardiovascular variables will be measured, and self-report questionnaires will be completed to evaluate autonomic response to the condition and subjective stress responses, respectively

NCT ID: NCT06236919 Not yet recruiting - Depression Clinical Trials

E-Emotio Project A Gamified Preventive School-based Paradigm Using Virtual Reality Technologies for Improving Emotional Regulation in Children and Adolescents.

e-Emotio
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Introduction and Significance: Preventive interventions have been shown to reduce the risk of developing anxiety and depression, making them a critical focus area in mental health promotion for children and adolescents. Enhancing emotion regulation (ER) skills in young people is one approach to preventing anxiety and depression, as ER involves cognitive processes of modifying thoughts and behaviors to manage emotional responses in different contexts. Executive functions (EF), such as cognitive flexibility, working memory, and inhibition, play a crucial role in ER development and regulation in children and adolescents. Recently, immersive virtual reality (IVR) has emerged as a novel tool for improving cognitive training interventions' accessibility and effectiveness. IVR allows users to experience immersive, three-dimensional environments, where they can interact with objects and events in a highly engaging and realistic way. Considering these developments, this study aims to explore the potential benefits of Enhance VR, a gamified IVR program designed to improve ER skills and reduce anxiety and depressive symptoms among children and adolescents. Methodology: The study will be a longitudinal, parallel, single-blind, randomized controlled pilot trial involving 80 Spanish - or English-speaking participants aged 10 to 16 years old. Participants will be excluded if they have severe psychiatric or neurodevelopmental disorders, physical, motor, or sensory impairments, or a risk of experiencing high cybersickness symptomatology during the VR experience. Participants will be randomly allocated into two groups: an experimental group receiving E-Emotio VR and a control group receiving a placebo-based VR relaxation experience. Both VR interventions will last five weeks, two times a week, for 30 minutes. The experimental group will engage in six games targeting cognitive flexibility, planning, reappraisal strategies, working memory, divided and sustained attention, and processing speed. The control group will be immersed in ten different nature-based VR environments and perform relaxation exercises. Baseline and post-intervention assessments will be conducted using age-adapted validated measures of depressive and anxiety symptoms, ER, executive function (working memory, cognitive flexibility, inhibition, and planning), and attention. Following the intervention, the assessment battery will be re-administered by a blinded assessor, and statistical analyses will be conducted for all the primary and secondary measures assessed before and after the intervention in both groups. Conclusion: In summary, this study aims to contribute to the development of effective preventive interventions for emotion regulation and mental health symptoms in children and adolescents by promoting ER through gamified VR cognitive training. The study's findings could have significant implications for mental health research, educational and clinical practice. By exploring the potential benefits of VR cognitive training, this research has the potential to inform future studies and clinical interventions aimed at improving young people's mental health and well-being. The gamification of cognitive training interventions could be a powerful tool for increasing engagement and motivation among young people, making them more likely to participate in such interventions.

NCT ID: NCT06205264 Not yet recruiting - Child Clinical Trials

Impact of Functional Strength Training Speeds on Executive Functions in 6-12-Year-Old Children.

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The cognitive development in children involves fundamental changes in their thinking and understanding of the environment, enhancing skills such as attention, memory, and problem-solving. This development is linked to intelligence and mental processes, positively affecting academic performance. The prefrontal cortex, the seat of executive functions, undergoes maturation, crucial for planning and behavior regulation. Factors such as rest, language learning, and physical activity influence these functions. The study highlights the interconnection between executive functions and cognitive development in children, emphasizing the importance of early stimulation. Physical activity, especially strength training, emerges as a determinant in improving cognition and executive functions, with intensity playing a crucial role. Therefore, the aim is to investigate the effect of strength training, focusing on increased intentional execution speed compared to a constant low-speed approach.

NCT ID: NCT06192745 Not yet recruiting - Sleep Clinical Trials

SCREENS: Sleep, Circadian Rhythms, and Electronics in the EveNing Study

SCREENS
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The proposed project aims to disentangle the impact of evening light exposure emitted from tablet devices from the impact of arousing media content on children's sleep regulation, circadian physiology and next-day emotion regulation and executive functioning.

NCT ID: NCT05665907 Not yet recruiting - Hearing Loss Clinical Trials

Evaluation of Executive Functions in Children With Cochleovestibular Deficit

Vestibulex
Start date: January 1, 2023
Phase:
Study type: Observational

Vestibular system activity supports many functions ranging from gaze stabilization and postural control to high-level cortical functions involving spatial cognition, body perception, verticality perception, orientation, navigation, and spatial memory. Few studies have assessed the impact of a vestibular deficit on executive functions taking into account the simultaneous existence of sensorineural deafness in a child population. The BRIEF questionnaire (Behavioral Rating Inventory of Executive Function) allows a parental assessment of executive functions and is validated from the age of 5. Children were recruited from a pediatric population followed in the Ear Nose and Throat (ENT) department for audio-vestibular assessment and BRIEF questionnaire was completed by the accompanying parent.

NCT ID: NCT05513339 Not yet recruiting - Sleep Deprivation Clinical Trials

Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows

Start date: September 15, 2022
Phase:
Study type: Observational

A reliable method for monitoring sleep, stress, and burnout among cardiology fellows is critically needed. To address this gap, our team aims to utilize the cost-effective WHOOP strap 4.0 wearable device to continuously capture stress-relevant physiologic data (i.e., sleep hours, heart rate variability, respiration rate, resting heart rate) among up to 21 Cardiology Fellows Thomas Jefferson University Hospital for 6 months.

NCT ID: NCT05468216 Not yet recruiting - Physical Activity Clinical Trials

Movement Integration in Primary Schools' Lessons

MovIn-Lessons
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The study assesses the effects of long-term movement integration intervention in academic lessons of primary education (6th grade) on physical activity levels and sedentary behaviour, executive functions, academic achievement and on-task behaviour. To achieve it, a cluster randomized controlled trial design will be adopted, where schools will be the clusters.

NCT ID: NCT04103463 Not yet recruiting - Cognitive Function Clinical Trials

Interactive Stepping Exercise on Memory

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

This is a randomized controlled trail. A total of 28 individuals with aMCI will be randomly assigned to either the ISE group or control group. The ISE intervention conducts three times a week for 16 weeks. Outcomes are measured at baseline and after intervention. The primary outcomes are the Chinese version verbal learning test (CVVLT), selective reminding test (SRT), and logic memory test (Wechsler Memory Scale). The secondary outcomes are Montreal Cognitive Assessment (MoCA) for cognitive function, and trail making test Part A & B (TMT-A & B), Stroop test, and 25-item Executive Interview (C-EXIT 25) for executive function.

NCT ID: NCT03946254 Not yet recruiting - Executive Function Clinical Trials

Effect of Strength Training on Executive Functions in Elderly People With Mild Cognitive Impairment

Executive-19
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Cognitive impairment or dementia is their last degree in one of the main concerns at a social level in these ages. To this day, there are different pharmacological and non-pharmacological therapies that can help prevent deterioration, as in this case, physical exercise. In the existing scientific literature, you can find a lot of information about the effect of aerobic exercise on cognition, but little is known about the effect of force exercise and its effect on general cognition and executive functions. Therefore, in this research the investigators will investigate the effect of strength training in people over 60 with a diagnosis of mild cognitive impairment in executive functions. For this, a controlled and randomized clinical trial will be developed in the city of Seville

NCT ID: NCT03491488 Not yet recruiting - Executive Function Clinical Trials

Brain Games to Improve Executive Function in São Paulo, Brazil

Start date: April 16, 2018
Phase: N/A
Study type: Interventional

A growing body of research has highlighted the critical importance of children's self-regulation and executive function skills for their school performance as well as for their later life outcomes. Starting around age three, children have a unique potential to improve these skills and establish positive behaviors that will support them in school and life. This project will adapt, implement and evaluate the effectiveness of the Brain Games intervention package as a tool to improve children's self-regulation and executive function skills. Brain Games were developed as part of larger behavioral intervention package in the US, and are designed to build the fundamental self-regulation skills that children need to be successful in school as well as later in life. The Brain Games curriculum will be adapted to Brazil, and evaluated through a 12 month randomized controlled trial with 60 crèches in São Paulo to assess its impact on children's self-regulation and executive functioning skills.