Clinical Research Directory

Brain Stimulation Effects on Cognitive Task Performance

The purpose of this study is to determine optimal task design parameters for the measurement of transcranial magnetic stimulation (TMS) effects on cognition.

EFFECT OF PERCEPTUAL-MOTOR TRAINING ON COGNITIVE FUNCTIONS, MOTOR ABILITIES AND QUALITY OF LIFE IN CHILDREN WITH ATTENTION DEFICIT HYPERACTIVE DISORDER

This study aims to Determine the effect of perceptual-motor training on: cognitive functions, motor abilities, and quality of life in ADHD children.

IMST for Dementia Risk Reduction

Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.

A Clinical Trial to Assess the Efficacy of a Single-dose of AlphaWave® L-Theanine on Cognitive Function in Healthy Adults With Moderate Stress

The goal of this clinical trial is to to assess the efficacy AlphaWave® L-Theanine on mental acuity/cognitive function and stress relief in healthy adults with moderate stress. The main question it aims to answer is: Is there a difference in change in mental acuity from pre- to post-dose between AlphaWave® L-Theanine and placebo? Participants will asked to provided a single dose of one capsule of a single dose of one capsule of AlphaWave® L-Theanine or one placebo capsule with 250 ml of room temperature water, and asked to complete tasks to assess cognitive function.

Investigation of Motor Imagery Ability, Body Awareness and Cognitive Functions in Type 2 Diabetes Mellitus

The aim of this study is to examine the relationship between motor imagery skills, body awareness and cognitive functions in individuals with Type 2 Diabetes mellitus.

Impact of a Novel Brain Longevity Supplement Containing the Postbiotic Urolithin A (Mitopure) on Cognitive Function and Related Health Outcomes

This is a parallel group, randomized, double-blind, placebo-controlled clinical study assessing the safety and effects of a novel nutritional product on self-reported cognitive function and health in adults that reside in the USA. Participants will take their assigned study product (active or placebo) for 8 weeks and answer validated electronic surveys assessing cognitive function delivered to them through a text message (SMS) link or through email.

Effects of In-between Meal Products on Cognitive Function in the Elderly

The overall aim of the present 9-week intervention study is to determine how a healthy drinkable in between meal affects cognitive function and brain activity in healthy adults 70 years and older. Secondary, the study also investigates the impact of the intervention on low grade inflammation, immune function, gut health, body composition, physical function, and well-being as secondary or exploratory outcomes. The study products have the potential to lower chronic low-grade inflammation in the elderly, improve nutrition and thereby contribute to healthy aging including cognitive function, and the study will also give additional insight regarding secondary and exploratory outcomes.

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 Function at Varying Dosages in Healthy Middle-aged and Older Adults With Self-reported Memory Problems

The goal of this clinical trial is to safety and efficacy of AP-Brain on cognitive function 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 function? Participants will be asked to consume AP-Brain at 1 g, 3 g, or 5g, or Placebo and asked to complete memory assessment questionnaires.

Radicle Clarity CNM™: A Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes Among E-Gamers

Radicle Clarity CNM™: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on cognitive function and related health outcomes among E-Gamers.

Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA. The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth. In this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years. The study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills.

Aronia, Cognition, and Eye Health (ACE)

There is great interest in improving cognitive performance and eye health as working from home becomes more prominent. Working from home as well as stress in the workplace is an increasing problem. Students and work professional can therefore benefit from improved attention and thus performance in academic and other work environments. A completely natural supplement with aronia melanocarpa extract could be a promising way to naturally improve cognitive performance

Radicle Clarity DSTTM: A Study Assessing the Impact of Health and Wellness Products on Mental Clarity and Related Health Outcomes

Radicle Clarity DSTTM: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on mental clarity and related health outcomes.

B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.

A poor nutrition status is a modifiable risk factor for cognitive decline and dementia. In particular, evidence links low status of certain B-vitamins and ω-3 fatty acids (ω-3 FA) with a greater risk of cognitive decline and dementia. Although these dietary components are typically investigated separately, post-hoc analyses of existing clinical trial data and experimental work indicate that B-vitamins and ω-3 FA may exert synergistic beneficial effects on processes related to brain health and cognition. However, this combination has not been tested directly in humans. In the proposed BOOMERANG project, we will study the effects of jointly supplementing with B-vitamins and a highly bioavailable ω-3 FA supplement, Lysoveta, on a robust biomarker of brain atrophy, the neurofilament light chain, in a double-blinded randomized controlled trial (RCT) over 3 months in older adults. We will also examine the secondary effects of the supplement of quality of life and cognitive function.

Oral Nutritional Supplementation in Children With Growth Concerns

Multi-center, single-blinded, randomized, controlled study consisting of two arms, to investigate the impact of an oral nutritional supplement in combination with dietary counseling on growth in children with growth concerns as compared to children who receive dietary counselling alone

The Effect of Arterial Carbon Dioxide Levels on Cerebral Blood Flow and Cerebral Autoregulation in the Steep Trendelenburg Position During Robot-assisted Prostatectomy, and Its Effect on Postoperative Cognition

Patients scheduled for robot-assisted prostatectomy will be randomized to either high or low concentrations of carbon dioxide in the blood. This will be managed by applying different ventilation strategies during anesthesia.The levels will be distinctly different. The investigators will assess whether different concentrations of carbon dioxide in blood results in different brain blood flow levels and different intracranial pressure during laparascopic surgery in the head-down tilted position. The investigators also will assess if different carbon dioxide level will manifest in different cognitive abilities in the two study groups, measured on day 1 post-surgery.

Radicle Clarity™ RBB: A Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes

A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes

Dose-Response Impact of Glucosyl-Hesperidin (CitraPeak) on Exercise Performance, Blood Flow, Stress, Cognition, and Other Perceptual Indicators

The purpose of this study is to evaluate the dose-dependent effects of glucosyl-hesperidin (CITRAPEAK) supplementation on exercise performance, recovery indicators, blood flow, cognitive function, mood, sleep, and fuel utilization in recreationally active adults.

Time Restricted Eating in Survivors Trial 2.0

After chemotherapy, older breast cancer survivors experience a faster decline in brain function. This can make it harder to enjoy life, stay social, and maintain independence. Chemotherapy can lead to poorer lifestyle habits, like unhealthy eating, less exercise, high stress, and poor sleep. Chemotherapy can also affect important health markers like blood sugar and cholesterol. Over time, these changes can damage blood vessels, which might lead to heart and brain issues. The investigators do not fully understand why brain function declines faster after chemotherapy, especially in older survivors, because there are many factors involved. In this study, the investigators will look at how lifestyle habits (like diet, exercise, stress and sleep), health markers (like blood sugar and cholesterol), and blood vessel health (like how well blood flows and how stiff the blood vessels are) affect brain function in older breast cancer survivors. The investigators will include 152 females aged 60-85 years, who finished chemotherapy for early-stage breast cancer at least 1 year ago. The investigators will use special tests to check different parts of brain function, like language, memory, and attention, as well as brain blood vessel health. This will help to understand which factors might speed up or slow down memory and thinking problems. Since many Canadian breast cancer survivors experience faster decline in brain function after chemotherapy, this study aims to find out what might make it worse. The results could help to create better and more personalized treatment plans for older breast cancer survivors that protect brain health and reduce problems with brain function in the future.

Exploring the Effectiveness of Somatosensory Cognitive Game Intervention on Cognitive and Physical Functions

This study investigates the effects of somatosensory cognitive games interventions on older adults' cognitive and physical functions. The investigators plan to recruit up to 100 participants and randomly assign them to a control group or an experimental group. The experimental group will participate in somatosensory cognitive games for 12 weeks, while the control group will receive routine care. Data will be collected via questionnaires to examine whether somatosensory cognitive games can delay declines in cognitive and physical functions in older adults.

Sarcopenia in Gestational Diabetes

Sarcopenia is a syndrome characterized by loss of skeletal muscle mass and strength, and physical performance deterioration. Prevalence of sarcopenia in elderly people is remarkably high (prevalence of about 25% in 60+ years people). In type 2 diabetes (T2D), sarcopenia is emerging as comorbidity of major concern. Sarcopenia, however, is not limited to elderly people, as it can develop also in younger individuals with prevalence around 9% or even higher according to some investigators. Of note, sarcopenia has been reported even in the 20-29 years interval. This interval includes women of childbearing age, thus raising the question whether sarcopenia may occur also in women with gestational diabetes (GDM) and whether this may affect pregnancy outcomes. Also, association between sarcopenia and cognitive impairment has been repeatedly reported, to the point that some authors have emphasized the importance of early sarcopenia recognition for prevention of cognitive impairment. Therefore, our main aims are: 1. To ascertain whether sarcopenia is present in GDM and, in that case, its prevalence; 2. To identify risk factors for sarcopenia; 3. To determine sarcopenia impact on pregnancy outcomes, and cognitive function. During pregnancy, all women will undergo oral glucose tolerance test (OGTT) for assessment of the glucometabolic condition. Several clinical variables of interest in sarcopenia will also be recorded. As regards the OGTT data, special focus will be on the assessment of insulin resistance, both at fasting and during the dynamic conditions determined by the OGTT. Notably, the special interest for insulin resistance is due to the reason that this type of metabolic alteration is known to be a risk factor for sarcopenia. In fact, all women will then undergo testing for diagnosis of sarcopenia (or presarcopenia), and all data and parameters will be analyzed to identify relationships between sarcopenia-related variables and GDM-related ones. It is worth noting that in consideration of the exacerbated insulin resistance condition often observed in GDM, the investigators expect indeed a not negligible prevalence of sarcopenia (or at least presarcopenia) in GDM women, despite the young (non-elderly) age. In addition, since insulin resistance is often present in pregnancy even in the absence of dysglycemia, the investigators do not exclude to identify some cases of sarcopenia/presarcopenia even in pregnant non-GDM women. This study will be the basis for future studies (also of interventional type), especially in women with GDM for prevention of sarcopenia and related possible pregnancy complication and adverse pregnancy outcomes, as well as for possibly contributing to mitigation of risk for T2D development in later life.

Exploring Virtual Reality Adventure Training Exergaming

The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on women veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed to examine effects on physical and mental health outcomes.

The Effects of Visual Input on Cognitive Function, Physical Performance, and Postural Stability in Adolescent Male Basketball Players

The aim of this study is to investigate the effects of exercises performed with stroboscopic glasses-recently gaining popularity in sports-on cognitive function, physical performance, and postural stability, which are among the key skills in athletic performance. The originality of the study lies in being the first to examine the effects of stroboscopic glasses-based exercises on basketball players. Hypotheses of the study: H1: Exercises performed with stroboscopic glasses have an effect on athletes' cognitive functions. H2: Exercises performed with stroboscopic glasses have an effect on athletes' physical performance. H3: Exercises performed with stroboscopic glasses have an effect on athletes' static and dynamic postural stability.

Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients

The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation. The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.