Clinical Research Directory

Cognitive Strategies in Early Psychosis 2

The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years. The investigators will study how two study agents change decision making in people with psychosis, by asking participants to complete some brain games on the computer before and after taking the study agents. The investigators hope to improve our understanding of psychosis to help people in the future. The main research questions are: * Does a single dose of modafinil change how people with psychosis play the brain games? * Does a single dose of d-serine change how people with psychosis play the brain games? * Does a single dose of modafinil change brain activity? * Does a single dose of d-serine change brain activity? Participants will: * Complete an interview and self-report questionnaires. * Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test. * Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain. There will be six scanning appointments in the study, with two scans each. Appointments will be about a month apart. * Take a single dose of a study agent during each scanning appointment. The study agent will be taken after the first fMRI. There are three study agents in total: modafinil, d-serine, and a placebo. Each participant will take each study agent twice during the study. * Play brain games on a computer that measure decision making, thinking, and problem solving skills

Human Neural Correlates of Multi-Timescale Inference

Adult epilepsy patients who are undergoing intracranial monitoring will participate in a simple behavioral task during the clinical recording period.

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.

Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health

In a single-blind, randomised, placebo-controlled crossover manner, this study aims to assess the impact of a high-fat mixed meal containing a whey protein (WP)-enriched milk fat globule membrane (MFGM) powdered ingredient on markers of heart and brain health in the fed state among middle-to-older-aged, postmenopausal women living with overweight and at moderate risk for cardiovascular disease. Participants will attend two \~8 hour study visits, where they will consume a high-fat meal containing a WP-enriched MFGM powdered ingredient or a placebo WP-based powdered ingredient. Each visit will involve anthropometric measurements and periodic assessments of heart health, including blood pressure and blood vessel stiffness measurements, blood sample collections, as well as computer-based tests measuring mood and cognition (brain function) over a 6-hour postprandial period.

Development of a Chatbot-supported Personalized Exercise Program for Older Adults and Evaluation of Its Effects on Cognitive Functions

The purpose of this study is to develop an artificial intelligence-based chatbot application to support exercise behavior in individuals aged 60 and over who do not regularly exercise, and to evaluate its effectiveness. In addition, the study aims to examine the effects of changes in exercise habits on the cognitive (mental) functions of older adults. In this study, the impact of a chatbot-supported personalized exercise program on cognitive functions in older individuals will be evaluated. A total of 90 participants is planned for inclusion in this study. If you agree to participate in this study, depending on the group you are assigned to, you may receive: * An artificial intelligence-based chatbot program, along with educational materials about the importance of exercise, or * Only educational materials (brochures) prepared by the researchers about the importance of exercise. At the beginning of the study, you will be asked to complete a data collection form. The same form will also be administered at week 12 and week 24. This form will include: * Basic information such as your age and gender, * Questions about your exercise habits, * A brief test to assess your cognitive (mental) functions, * Questions evaluating your level of physical activity. The study duration is 24 weeks, including 12 weeks of intervention and 12 weeks of follow-up.

Retrospective Analysis of CPET and Cognitive Tests of Healthy Individuals, Treated With 60 Treatment of HBOT

This retrospective observational study evaluates physiological and cognitive changes following a series of 60 hyperbaric oxygen therapy (HBOT) sessions in healthy individuals. Participants underwent treatment five days per week, each session included 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes. Pre- and post-treatment data include cardiopulmonary exercise testing (CPET) and standardized cognitive assessments. The study aims to characterize associations between changes in cardiorespiratory fitness and cognitive performance following repeated HBOT exposure in a real-world clinical cohort

The Impact of Whey Protein on Frailty in Older Adults Classified as Pre-frail

This pilot study aims to determine the impact of whey protein supplementation on brain antioxidant levels and to assess the effects of whey protein supplementation on physical function, body composition, and cognition in pre-frail older adults.

DEVELOPMENT AND PSYCHOMETRIC EVALUATION OF THE NEUROCOGNITIVE UPPER EXTREMITY TESTS: A RELIABILITY AND VALIDITY STUDY

The goal of this observational study is to develop an upper extremity neurocognitive performance test battery, determine its reliability and validity, and investigate the effect of neurocognitive load on test performance in athletes and healthy volunteers aged 18-40. The main questions it aims to answer are: Are the developed upper extremity neurocognitive tests reliable and valid tool for assessment? Does the addition of neurocognitive load significantly affect upper extremity physical performance scores? Are the neurocognitive performance test results related to shoulder rotator cuff muscle strength, rate of force development, and shoulder function? Researchers will compare the neurocognitive performance of athletes to healthy non-athlete individuals to see if the test battery can effectively differentiate between these two groups (discriminative validity). Participants will: Complete demographic forms and questionnaires regarding activity level and shoulder function. Undergo shoulder range of motion and isometric strength/rate of force development assessments. Perform a battery of 4 neurocognitive tests integrated with a light-based reaction system. Perform the same functional tests without neurocognitive load to serve as a baseline for comparison. (Athletes only) Attend additional sessions to evaluate the feasibility of the tests and to assess test-retest reliability with a one-week interval.

The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV

The goal of this clinical trial is to examine the effects of a telephone-delivered Brief Behavioral Treatment Insomnia (BBTI) versus a Brief Mindfulness Treatment (BMT) on cognitive and sleep outcomes in older adults with HIV. The main questions it aims to answer are: What are the effects of BBTI vs BMT on self-reported and observed sleep outcomes in older adults with HIV and insomnia up to 1-year post-intervention? What are the effects of BBTI vs BMT on self-reported and observed cognitive comes in older adults with HIV and insomnia up to 1-year post-intervention? What is the association between Alzheimer's Disease biomarkers and sleep and cognitive outcomes in older adults with HIV receiving BBTI vs BMT? Participants will: * Complete 4 weeks of telephone-delivered BBTI or BMT * Attend baseline, post-intervention, and 1-year post in-person visits for sleep and cognitive assessments * Have blood collected at all three time points

Evaluating the Effects of tDCS on Sleep and Cognition in Healthy Older Adults

The goal of this interventional study is to learn if transcranial direct current stimulation (tDCS), a gentle, cost-effective and non-invasive brain stimulation technique can improve sleep brain activity during an afternoon nap. Since these sleep brain patterns are linked to better memory, attention, and thinking skills, this study aims to find out if improving sleep in a nap can also enhance these cognitive skills in healthy older adults (aged 60+). The main questions it aims to answer are: * Can a short (20-minute) tDCS session before a nap improve sleep patterns during the nap? * Since these sleep patterns are linked to memory and attention, can tDCS also improve thinking skills after the nap? * Are two tDCS session more effective than one for improving nap sleep and thinking skills? Participants will: • Be required to come to the university for testing over four days. During each session they will: * Complete computer based-tasks to assess memory and thinking. * Receive a 20-minute session of either real (active) or fake (placebo) tDCS. * Take a short, monitored nap while researchers measure sleep activity (using polysomnography - a gold-standard, non-invasive sleep monitoring tool). * Complete an easy-to-use sleep test at home on the nights after the naps. * Wear a lightweight watch (called an Actiwatch) throughout the study period to track sleep and movement. * Complete daily sleep diaries. By taking part, participants will help researchers understand whether tDCS can improve sleep during naps and, in turn, support memory and thinking skills. This research could lead to better treatments for sleep problems, help protect brain health, and reduce the risk of dementia as people age. The brain stimulation in this study may also help improve their sleep and cognition.

Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia

The purpose of this study is to explore whether intensive music therapy can help improve cognitive functions like memory, attention, and decision-making skills in stroke patients who are undergoing rehabilitation. This is a feasibility study, meaning it's also designed to see how practical it is to include music therapy as part of stroke rehabilitation. The investigators want to learn how well patients can participate in and stick with this type of therapy, and whether it fits well with other treatments that stroke patients usually receive. By understanding this, the investigators can assess the resources, staff training, and planning needed for music therapy to be part of stroke recovery in the future. The study will also help the investigators estimate the effects of music therapy, which will be used to design a larger, more detailed study in the future.

GUTLINK4KIDS Intervention

This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.

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.

Magnesium and Cognition After Stroke

Cognitive impairments such as memory impairments, word-finding difficulties, compromised orientation and perception are often observed in stroke patients. Low serum-mg-concentrations are associated with cognitive impairments in ischemic stroke patients one month after stroke onset. It is not clear, if cognitive impairments after stroke is caused by the mg-deficiency or by the stroke itself. Until now, no studies investigating the relationship between mg-concentration, stroke severity and cognition during treatment course are available. Thus, this study aimed to investigate the relationship between mg-concentration and cognition of stroke patients.

Effects of Cognitive Dual-Task on Gait in Parkinson's Disease

The aim of this study is to evaluate gait in individuals diagnosed with PD under tasks involving different cognitive domains, to compare the results with those of age and sex-matched healthy individuals, and to determine which cognitive function has the greatest impact on gait in PD.

Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?

This study aimed at helping researchers understand how a medication called haloperidol can affect insulin action in the brain. Insulin is a hormone in the body that controls sugar levels in part by lowering the amount of glucose produced by the liver. After eating a meal, insulin levels go up in both the blood and the brain. Insulin in the brain has also been shown to affect the way the brain works and processes information (also known as "cognition"). Haloperidol, is an antipsychotic medication used to treat a variety of disorders such as schizophrenia spectrum disorders, bipolar disorder, and major depressive disorder, but long-term use can have metabolic side effects, like weight gain, type 2 diabetes, and cardiovascular disease. The purpose of this study is to investigate how antipsychotic medications, such as haloperidol, which carries the risk of metabolic changes, might interrupt the effect of insulin action in the brain. This will help researchers learn how to potentially reduce metabolic risk for people who take these kinds of medications in the future.

Effects of Breathing Exercises on Cognition in Older Adults

The goal of this interventional clinical trial is to investigate the effects of breathing exercises added to balance training on cognitive function in individuals aged 65 years and older. The main questions it aims to answer are: Do breathing exercises affect cognition? Do different breathing exercises affect cognition in different ways? Researchers will administer two different breathing protocols and evaluate cognition before and after each protocol. Participants will take part in an 8-week program consisting of sessions that include 30 minutes of balance-based exercises and 15 minutes of breathing exercises. Sessions will be held twice weekly under the supervision of a physical therapist.

Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury

This study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on HIV-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with HIV.

Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression

This observational study investigates the use of Esketamine Intranasal Spray in patients with Treatment-Resistant Depression in Real-World Settings. The study aims to evaluate the clinical outcomes, including efficacy and safety, of esketamine treatment. It also explores predictors of treatment response, focusing on biological pathways such as genetics, neuroimaging, and psychophysical measures. Additionally, the study examines how esketamine impacts patients' life functioning, including social and occupational aspects. The goal is to better understand who benefits most from esketamine and how it affects daily life, to improve personalized care for patients with difficult-to-treat depression.

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.

Psychological and Lifestyle Factors That Predict Adherence of Multi-domain Interventions for Promoting Brain Health

Ageing is associated with a rising burden of neurological disorders, particularly dementia, which are now the leading cause of disability worldwide. Many dementia cases could potentially be prevented by modifying lifestyle factors such as physical inactivity, unhealthy diet, poor sleep, low social engagement and psychological distress. The Barcelona Brain Health Initiative (BBHI), a longitudinal cohort of more than 6,000 adults aged 40-75 years, has shown substantial inter-individual variability in lifestyle and psychological profiles and has identified subgroups at higher risk for poorer brain health. ToBrainHealth is an 8-week, three-arm controlled intervention nested within BBHI. It evaluates different levels of personalisation and support to optimise healthy lifestyle behaviours using the ToBrainHealth platform, a digital platform that delivers recommendations, collects self-reported behaviours and integrates data from wearable activity trackers. A total of 120 BBHI volunteers classified as moderate- or high-risk based on previous lifestyle and psychological questionnaires will be selected (40 per arm). Allocation to study arms will be pseudo-randomised, stratified by age, sex, and lifestyle and psychological profiles. The three groups are: (1) a control group receiving only generic, non-personalised education about healthy lifestyles and regular online questionnaires, without use of ToBrainHealth platform tailoring; (2) a digital personalised intervention group using ToBrainHealth platform to deliver tailored lifestyle recommendations, adaptive intervention strategies and remote asynchronous supervision, supported by data from questionnaires and wearables; and (3) a digital personalised intervention plus intensive health-coaching group, which receives the same ToBrainHealth platform-based programme plus structured, proactive support and supervision by health professionals to enhance motivation and adherence. The primary outcome is adherence to the lifestyle intervention, operationalised as the percentage of recommended activities and goals achieved during the 8-week programme, based on platform's logs, questionnaires and wearable data. The study will test whether lifestyle and psychological profile increases adherence compared with generic education, and whether adding intensive coaching provides additional benefit (expected gradient: coaching \> digital only \> control). Secondary outcomes include the clinical impact of the intervention on brain-health-related measures. All participants will undergo pre- and post-intervention assessments including a brief medical evaluation (vital signs and anthropometrics), a digital neuropsychological battery, and questionnaires on motivation, lifestyle and psychosocial variables. These data will be analysed together with existing BBHI longitudinal information to explore changes in cognitive performance, health status and psychological wellbeing, and to characterise patterns and predictors of adherence across intervention arms. The trial will also assess feasibility and acceptability of ToBrainHealth platform as a remote monitoring and coaching tool for brain-health promotion. Results are expected to generate new knowledge on the role of psychological and lifestyle profiles in adherence, and to inform scalable, technology-supported, personalised interventions aimed at preserving brain health and reducing the long-term risk of cognitive decline in community-dwelling adults.

Peanuts for Cardiometabolic, Brain, and Intestinal Health

The overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.

Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure

The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.