Clinical Research Directory

Trial of Pistachio Consumption in Older Adults

The goal of this study is to evaluate whether a pistachio-enriched diet leads to changes in cognitive function, cardiometabolic risk factors, and life satisfaction in older adults over a 6-month period.

Effects of Cannabidiol on Memory and Attention in Adults Aged 60-70: A Pilot Study

This pilot study aims to investigate the effects of a single oral dose of cannabidiol (CBD) on memory and attention in healthy adults aged 60 to 70 years. CBD is a naturally occurring compound found in cannabis that does not produce the intoxicating effects associated with THC. The main research question is whether CBD can improve episodic memory (the ability to remember previously learned information), working memory (the ability to temporarily hold and use information), and attention compared with placebo. The researchers hypothesize that participants will perform better on memory and attention tasks after receiving CBD than after receiving placebo. The study will involve approximately 50 healthy adults aged 60 to 70 years. Each participant will attend two study sessions, scheduled 14 to 30 days apart. During one session, participants will receive a single oral dose of 25 mg CBD, while during the other session, they will receive a placebo capsule containing no CBD. The order of administration will be randomly assigned, and neither the participants nor the researchers assessing their performance will know which capsule was administered during each session. Memory and attention will be evaluated using standardized memory tests and computer-based cognitive tasks. The findings will provide preliminary evidence on the potential effects of CBD on cognitive functioning in older adults.

Targeted Assessment of Cognition and Tactical-performance With Ingested Ketones

The goal of this study is to determine whether consuming a commercially available exogenous ketone supplement (KetoneIQ®) affects cognition, specifically marksmanship, under physical stress (i.e., exhaustive exercise). The main questions we seek to answer are: * Does the supplement save cognitive performance under stress compared to a placebo? * Does the supplement improve marksmanship under stress compared to a placebo?

A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers

The goal of this clinical trial is to evaluate whether a home-based mHealth intervention can improve adherence to the 24-Hour Movement Guidelines in preschool-aged children (3-4 years old) who currently meet 0 or 1 of the guidelines for physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Can the intervention increase the proportion of children meeting all three 24-Hour Movement Guidelines (physical activity, screen-time, and sleep)? * Is the intervention feasible for parents to implement, as measured by a parent feedback survey? Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence. Parents and Participants: * Children will wear an accelerometer to track physical activity and sleep patterns. * Parents will use a mobile app that delivers weekly lessons and behavior-related goals to encourage healthy movement behaviors in their children. * Parents will complete questionnaires on their child's movement behaviors and development at baseline, 6 weeks, and 12 weeks. * Additionally, children will undergo motor skills assessments, and parents will provide feedback on cognitive development and behavioral changes.

Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Cognition, Dual-Task Performance, and Interoceptive Accuracy

This study aims to determine the simultaneous effects of transcutaneous auricular vagus nerve stimulation (taVNS) at two frequencies (30 Hz and 100 Hz) compared to sham stimulation on cognitive functions, dual-task performance, and interoceptive accuracy in healthy adults. taVNS non-invasively activates vagal afferent fibers through electrical stimulation of the outer ear (cymba conchae and tragus), which are exclusively innervated by the auricular branch of the vagus nerve. Its proposed mechanism involves activation of the locus coeruleus-norepinephrine system and insular/prefrontal projections, providing a putative neurobiological basis for cognitive modulation. Ninety healthy volunteers (18-45 years) will be randomly assigned to one of three parallel groups: sham taVNS (n=30), active 30 Hz taVNS (n=30), or active 100 Hz taVNS (n=30). Each participant completes two sessions separated by one week: Session 1 (baseline, no stimulation) and Session 2 (experimental, stimulation active). Assessments include dual-task cost (3-Meter Tandem Walk Test with serial subtraction), executive function (Stroop Test), processing speed (Deary-Liewald Reaction Time Task), interoceptive accuracy (Heartbeat Counting Task), and heart rate variability (Polar H10). Sleep quality (PSQI), depression (BDI), physical activity (IPAQ-SF), and fatigue (Chalder Fatigue Scale) are measured at baseline as potential moderators. This is the first double-blind, sham-controlled study to simultaneously evaluate the effects of taVNS on these three constructs within a single experimental design, and the comparative frequency analysis (30 Hz vs 100 Hz) will contribute to parameter optimization for taVNS applications.

Newenkantun: a Play-based Program to Promote Socioemotional Learning in Early Childhood Education in Chile.

What is this study about? This study will test a program called "Newenkantun" (which refers to a hand-strength game in Mapuche culture) designed to help young children develop important social and emotional skills through play and physical activity. The program focuses on helping children learn how to understand and manage their emotions, get along with others, and make good decisions - skills that are important for success in school and life. Why is this study being done? The early years of childhood are a critical time for developing social, emotional, and physical skills. Many children, especially those from low-income families, face challenges that make it harder to develop these skills. This study will test whether a program that combines active play, social-emotional learning, and family involvement can help young children in the Araucanía region of Chile develop these important abilities. The program also aims to help children be more physically active, spend less time on screens, and get better sleep - all of which are important for healthy development. Who can participate? Children ages 4-6 years old (attending transition levels 1 and 2 in early childhood education) in the cities of Temuco and Padre Las Casas in the Araucanía region of Chile. Both their teachers and parents/guardians will also participate in the program. What will participants do? Children will participate in play-based activities at their schools over 16 weeks. These activities use storytelling and imaginative play (like pretending to be different characters) to help them practice social and emotional skills. The activities respect and incorporate the cultural background of the Araucanía region, including Mapuche cultural elements. Teachers will receive training and support (both in-person and online) to learn how to teach social-emotional skills and promote healthy movement behaviors in their classrooms. They will receive materials and kits to help them run play activities. Parents and guardians will receive support through an online platform, app, social media, and printed materials. They will learn about the importance of social-emotional development and healthy movement habits, and get practical tips for supporting these at home. The program includes 8 topics delivered over 4 months, with each topic taking about 30 minutes to complete. What will be measured? Researchers will measure: Children's social and emotional skills (like managing emotions, getting along with others, and making responsible decisions) Physical activity levels, screen time, and sleep patterns Motor skills and thinking abilities Teachers' confidence and practices in teaching social-emotional skills Parents' support practices at home The school environment and how well it supports these skills These measurements will happen at the beginning of the program, at the end, and at follow-up visits 3, 6, and 12 months after the program ends. How is the study designed? The study uses a "stepped-wedge" design, which means that 10 schools will start the program at different times, chosen randomly. This design allows all schools to eventually receive the program while still allowing researchers to compare results. Each school will participate for 16 weeks, and researchers will follow what happens afterwards to see if the benefits last over time. What are the potential benefits? If successful, this program could provide a practical, culturally appropriate way to help young children develop important social, emotional, and physical skills during a critical time in their development. The program is designed to be sustainable and could potentially be used in other schools and communities in the future.

Feasibility of High-intensity Functional Exercise With Simultaneous Cognitive Challenge for Older People With Falls Risk

This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims: 1. To investigate the acceptability and safety of the HIFE+cog program in older people at risk of falls, and the methods used in the study by evaluating recruitment, compliance with the intervention, severity of adverse events reported, and participant experiences. 2. To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences. The study is designed as a randomized controlled pilot trial. Eligible participants will be randomized to either the intervention group (HIFE+cog) or the active control group (HIFE) to partake in individually tailored exercise, supervised and progressed by a physiotherapist, two times per week for 3 months.

The Effects of Immersive Virtual Reality in Patients With Grade 1-2 Adhesive Capsulitis

Adhesive capsulitis (frozen shoulder) is a complex condition characterized by inflammation, fibrosis, and restriction of movement in the shoulder capsule, significantly limiting an individual's participation in daily living activities. It is most commonly observed in individuals aged between 40 and 60 years, and its treatment frequently involves approaches such as manual therapy, exercise, corticosteroid injections, and electrotherapy. However, these conventional methods may be limited by factors such as lack of motivation, pain-related avoidance behavior, and poor treatment adherence. Today, immersive virtual reality technologies introduce a new dimension to rehabilitation by gamifying exercise, providing sensory feedback, and enabling graded exposure through mechanisms such as distraction and engagement. They also enhance motivation and compliance with exercise programs. Studies in the literature have reported that virtual reality-based exercise is an effective method for reducing pain levels in patients diagnosed with frozen shoulder. However, only a limited number of studies have specifically examined the effects of immersive virtual reality in patients with adhesive capsulitis. To date, no study has investigated the impact of immersive virtual reality interventions on sleep and cognitive functions in these patients. Furthermore, the combined effect of patient education, home exercise programs, and immersive virtual reality therapy has not yet been explored. For these reasons, the present study aims to investigate the effects of immersive virtual reality-based exercise therapy on pain, functionality, sleep, and cognitive functions in patients with Grade 1-2 adhesive capsulitis.

Low Load With Blood Flow Restriction for Improving Strength, Balance, and Cognition in Older Adults

This study aims to examine the effects of low load resistance exercise with a blood flow restriction cuff on muscle strength, balance, physical performance, depression, and cognitive function in community-dwelling older adults.

Exercise-Induced Lactate and Cognitive Function (ExLBC)

A single bout of exercise can rapidly improve cognitive functions including memory, attention, and executive functions, which help us navigate through everyday life. However, we do not fully understand the mechanism behind this process. A promising candidate mechanism is lactate, which was previously considered merely a waste product of our muscles during exercise. It is now recognized as an important molecule that is used by the brain as an energy source. Studies have shown that increases in lactate during exercise are positively related to improved cognitive function after completion of exercise. Another potential mechanism involves the increase in neurotrophins such as brain-derived neurotrophic factor (BDNF) following exercise. The increase in lactate and BDNF during exercise may be connected to cause these cognitive improvements. However, because lactate increases with higher exercise intensities, we currently do not know how lactate specifically impacts brain health. To address this, muscle and blood lactate concentrations can be experimentally manipulated during exercise using sodium bicarbonate (NaHCO3) supplementation and will allow us to explore how lactate specifically affects brain function. The purpose of this project is to investigate the effect of exercise-induced lactate on BDNF and cognition following oral NaHCO3 supplementation in young adults. We hypothesize that BDNF levels will be higher, and cognition will be improved in executive function, visuospatial memory, and working memory in the NaHCO3 condition due to higher plasma lactate during exercise compared to placebo.

Short Term Effects of a Multimodal Intervention With RGM on Cognition in People With Parkinson's Disease.

The goal of this clinical trial is to learn if the Ronnie Gardiner Method (RGM) works to improve cognitive functions in adults with Parkinson's disease (early to mid-stage). It will also learn about the secondary effects on speech, mobility, balance, and mood. The main questions it aims to answer are: * Does a 10-week RGM intervention improve cognitive aspects, speech (indirectly through improved breathing), mobility, and balance in participants with Parkinson's disease? * How do participants experience the intensity, difficulty, and emotional impact of the RGM sessions?

The Effect of Remotely Delivered Pilates on Physical , and Psychological Outcomes in Individuals With Multiple Sclerosis

Objectives Objective 1: To determine the effects of a 16-week remotely delivered Pilates intervention on walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Objective 2: To examine the impact of a 16-week remotely delivered Pilates intervention on depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Aim Aim 1: To assess whether the 16-week remotely delivered Pilates intervention significantly improves walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS Aim 2: To investigate whether the 16-week remotely delivered Pilates intervention significantly improves depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Hypothesis Hypothesis 1: The 16-week remotely delivered Pilates intervention will significantly improve walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Hypothesis 2: Participants receiving the 16-week remotely delivered Pilates intervention will demonstrate significantly greater improvements in depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS.

7T Amygdala and Citalopram Study

The goal of this study is to investigate how a common antidepressant citalopram (which increases the levels of the chemical messenger serotonin), affects how a key area of the brain involved in depression (the amygdala) responds to emotional information. Healthy participants will undergo medical and psychiatric health screening, after which they will be assigned to receive either a single dose of citalopram (20mg) or placebo, and undergo brain scanning (7T fMRI) whilst viewing emotional faces. Since the scan uses high field strength, the investigators will be able to see effects of citalopram on different subfields within the amygdala which will help to understand how citalopram might be working.

Reliability of Standardized IQ Testing Under Modafinil, Racetam-Class Compounds, Sleep Restriction and Daily Activity

This study examined whether standardized IQ test scores in healthy adults aged 18-35 are stable measures of cognitive ability and evaluated whether standardized cognitive-test performance and response-initiation measures vary across pharmacological and sleep conditions. Seventy healthy volunteers were assessed at seven in-person timepoints over six months, with 25 participants receiving an inert matched preparation and 45 receiving modafinil or one of four racetam-class compounds (oxiracetam, pramiracetam, phenylpiracetam, aniracetam) administered orally before testing. A different standardized instrument was administered at each timepoint to limit item-level recall and practice effects, and change in the placebo group was used as the reference for estimating practice effects. Participants were assessed under both rested and sleep-restricted conditions, two psychologists were present at every administration to code response initiation (hesitation), and physiological state was monitored using a consumer wearable. Psychometric changes were evaluated relative to the standard error of measurement of the instruments and the study's prespecified minimum detectable effect. Response-initiation measures were analysed separately from psychometric scores to evaluate potential effects on response initiation and execution time.

The Effects of High-Intensity Interval Training on Gait, Balance, and Cognitive Functions in Individuals With Multiple Sclerosis

This study aims to comparatively investigate the effects of low-volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training (MICT) on gait, balance, cognitive functions, and neurovascular biomarkers (BDNF, VEGF) in individuals with Multiple Sclerosis (MS). This randomized controlled trial will be conducted at Hacettepe University, Faculty of Physical Therapy and Rehabilitation.

The Effects of Tyrosol and Creatine on Exercise Performance and Cognition in Healthy Adults

This study will be a randomized, double-blind, placebo-controlled trial. It will be conducted over a 8-week intervention investigating the effects of creatine (5g Creatine monohydrate); placebo control (5g resistant dextrin), and a combination group containing both creatine and tyrosol (5g creatine monohydrate + 150mg tyrosol/day). Endurance, strength, cognition, and fatigue resistance will be examined through repeated strength and endurance testing (described below). Participants who pass initial screening will be invited on-site for day one (Visit 1) of testing where the participants will proceed with a series of tests which will include the following: (1) body composition; (2) mood and cognitive testing; (3) full-body strength testing; (4) 5RM (repetition maximum) bench press, leading to multiple sets of bench press (based on the previous weight) completed to failure; (5) finally, a time to exhaustion endurance test will be conducted followed by (6) repeat cognitive testing. After the 8-week supplementation period (\~56-60 days), all original measures will be repeated as before in the same order (Visit 2). Approximately 24 hours later (Visit 3) participants will complete a questionnaire for muscle soreness remotely, and again at 48 hours post-Visit 2 (visit 4).

Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD

Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.

Dual-Task Balance and Gait Training Combined With Cognitive Training in Parkinson's Patients

The aim of the study is to examine the effects of a structured, cognitive dimension-specific cognitive training combined with dual-task balance and gait training on balance, gait, and cognition in individuals with Parkinson's disease.

Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults

This study is a pre-post, open-label cohort study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for either 1 month or 6 months. During the study, participants will complete online cognitive tasks and provide blood and stool samples collected during home visits by trained staff. The samples will be analysed to explore changes in gut bacteria and other biological markers. This study aims to understand whether the supplement is well tolerated and whether measurable biological changes occur. The study does not involve any experimental drugs or invasive procedures beyond blood sampling and stool collection, and participants will not be asked to change any current prescribed medications or treatments; with eligibility exclusions applying for recent antibiotics or immunosuppressants. The supplement is being studied for research purposes only and is not intended to diagnose, treat, or prevent disease. Participants will be invited to participate in a follow-up visit to assess long-term effects.

Heart Rate Variability for Practitioner Stimulated Reflection and Decision-making Optimisation

At the heart of healthcare is the interaction between healthcare practitioners and patients. It is believed that optimisation of this interaction can improve patient relevant outcomes, safety and patient experience. Through utilisation of practitioner physiological data, heart rate variability (HRV), to help practitioners make better decisions and optimise practice, it is considered possible to improve decision making around patient care and improve outcomes and safety. The modern intensive care unit (ICU) is a dynamic data rich environment requiring rapid and accurate decision making. Advances in ventilator technology, electronic patient monitoring and electronic health records (EHR) have provided exponential growth in data produced for patients and the need for complex decision making. However, data overload and alarm fatigue can result in poor understanding and a delayed response from the practitioner in addressing the patient's needs. The aim of this study is to present and evaluate a psychophysiology training approach for practitioners derived from their cardiovascular response through the course of the working day, this will be measured using heart rate variability (HRV). Practitioner HRV has been shown to be linked to work related stress and is considered a biomarker of decision-making.

A Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Function at Varying Dosages in Healthy Younger Adults With Self-reported Attention Problems

The goal of this clinical trial is to investigate the safety and efficacy of AP-Brain on cognitive function at varying dosages in healthy younger adults with self-reported attention problems. The main question it aims to answer is what Change from baseline to Day 56 between AP-Brain (1g, 3g, or 5g) and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score and complex attention. Participants will be asked to consume AP-Brain at 1 g, 3 g, or 5g, or Placebo and asked to complete memory assessment questionnaires.

A Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Performance at Varying Dosages in Healthy Middle-aged and Older Adults With Self-reported Memory Problems

The goal of this clinical trial is to investigate the safety and efficacy of AP-Brain on cognitive performance at varying dosages in healthy middle-aged and older adults with self-reported memory problems. The main question it aims to answer is: What is the effect of AP-Brain at 1 g, 3 g, and 5 g on cognitive performance? Participants will be asked to consume AP-Brain at 1 g, 3 g, or 5g, or Placebo and asked to complete memory assessment questionnaires.

Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults. The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

Effects of Beef-Forward Ready-to-Eat Meals on Recovery Following Simulated Fire Suppression Activities

This clinical trial aims to determine whether consuming beef-based protein before and after physically demanding simulated firefighting activities improves recovery, physical performance, and cognitive performance in healthy adult firefighters. The study will also compare beef-based protein meals with plant-based protein meals. The main questions this study aims to answer are: Does consuming beef-based protein reduce changes in markers of muscle damage, physiological stress, and muscle soreness following a simulated fire ground test? Does consuming beef-based protein help maintain or improve physical and cognitive performance during recovery compared with plant-based protein? Researchers will compare two ready-to-eat meal conditions: beef-based protein, and plant-based protein. Each participant will complete all two conditions in a randomized crossover design, with 14 to 21 days between conditions.