Treatment Trials

736 Clinical Trials for Various Conditions

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COMPLETED
The Impact of Twin Hearts Meditation on Mood, Cognitive Functioning, and EEG Dynamics
Description

The goal of this clinical trial is to examine the impact of a specific guided meditation (Twin Hearts Meditation; THM) on cognitive functioning and EEG dynamics in experienced and inexperienced meditators. The main questions it aims to answer are: * Will the experienced meditators outperform inexperienced meditators on the attention control tasks (Flanker, Trails A \& B) at baseline (pre-meditation)? * Will both groups show improvements in performance after meditation associated with mood and physiological state changes? * Will the experienced meditators show an overall mood profile of higher positive mood states and less negative mood states (Brunel Mood Scale subscale difference) at baseline (pre-meditation)? * Will both groups show mood state improvements after meditation? * Will the experienced meditators show differences in electrophysiological characteristics compared to inexperienced meditators? * Will inexperienced meditators exhibit shifts from their baseline resting-state EEG towards being more similar to the EEG characteristics of experienced meditators at baseline? * Will experienced meditators demonstrate differences in P300 latencies and amplitudes on the auditory oddball paradigm. Participants will: * Take a series of pre-meditation surveys. * Complete pre-meditation P300 auditory oddball task. * Complete pre-meditation cognitive behavioral task set. * Continuous 19-channel EEG recording before and after pre-recorded guided THM. * Take a series of post-meditation surveys. * Complete post-session P300 auditory oddball task. * Complete post-session cognitive behavioral task set.

NOT_YET_RECRUITING
Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
Description

The purpose of this research study is to explore ways to improve motor, cognitive and immune functions for aging adults using multiple techniques like lifestyle changes and risk factor management, as well as medications and supplements believed to have a positive effect on health.

RECRUITING
Effect of Walnuts on Cognitive Function and Gut Microbiome in Older Adults
Description

The purpose of this study is to examine the impact of daily consumption of walnuts for 12 weeks on cognitive function, markers of inflammation and oxidative stress, and the gut microbiome in healthy adults age 55 years and older.

RECRUITING
Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis
Description

The purpose of this study is to examine whether an 8-week online educational group-based program tailored to people with systemic sclerosis can help improve cognitive function and well-being. The study team hypothesize that participants that receive the intervention will have better improvements immediately after treatment at week 8 in all cognitive function measures, non-cognitive symptoms, and self-management compared to those in the waitlist control.

Conditions
NOT_YET_RECRUITING
How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?
Description

The goal of this clinical trial is to investigate how iron status and heavy bleeding during the menopausal transition affect women's cognitive function and quality of life. The main questions it aims to answer are: * What is the association between iron status, cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women? * How does iron repletion, via supplementation, affect cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women? The investigators will compare the effect of iron supplements to a placebo (gelatin capsule) to see if iron supplements could improve iron status, cognitive function, mood, quality of family relationships, and quality of life of iron-deficient and/or anemic women undergoing the menopausal transition. Each participant will: * Make 2 visits (about 2 hours each - baseline and endline) to the Clinical Research Center at Purdue * Make a very brief visit at midpoint (about 10 minutes) for a checkup * Take a daily study supplement or placebo for 4 months

RECRUITING
Cognitive Rehabilitation for Veterans With MDD-related Cognitive Functioning Deficits
Description

Individuals with depression often describe difficulties with memory, attention, concentration, and overall cognitive functioning, which can persist even after mood episodes get better, and can affect treatment and health outcomes. The primary objective of this pilot clinical trial is to evaluate the feasibility and acceptability of a manualized, 8-week, Compensatory Cognitive Training (CCT) intervention for Veterans who received treatment for MDD in the past year and have persistent cognitive functioning deficits. The investigators will compare Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) to a robust comparator, Goal-focused Supportive Contact (GSC), to evaluate differences in outcome measures. The investigators hypothesize that Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) will be feasible and acceptable to participants in a pilot trial of ME-CCT-MDD vs. Goal-focused supportive contact (GSC) for Veterans with recent MDD treatment and persistent cognitive symptoms. This study will also evaluate the preliminary magnitude and direction of symptom change on measures of objective cognitive functioning, psychiatric symptomatology, psychosocial functioning, and quality of life. The investigators hypothesize that CCT will improve objective cognitive functioning, psychiatric outcomes, psychosocial functioning, and quality of life in Veterans with recent MDD-related cognitive functioning deficits. Participants who agree to participate in the study will: 1. Take part in an assessment of their cognition, symptoms, and functioning, which will take approximately 2 hours. The assessment will include an interview about their medical, psychiatric, and cognitive history. It will also include questionnaires about their symptoms and daily functioning as well as neuropsychological tests, which are paper-pencil tests that evaluate aspects of cognition such as memory, attention, and problem-solving skills. 2. Be randomly assigned (like the flip of a coin) to receive Goal-Focused Supportive Contact or Compensatory Cognitive Training. Both treatments will involve weekly groups with a mental health provider for approximately 2 hours per week for 8 weeks. Goal-Focused Treatment includes setting and achieving short-term and long-term goals for improving cognition and functioning. Compensatory Cognitive Training includes training in strategies to improve cognition and manage stress. 3. Complete a follow-up assessment of cognition, symptoms, and functioning 8 weeks after they begin treatment, as well as a brief interview about their experience in the group. These assessment sessions will take approximately 2 hours.

RECRUITING
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
Description

This randomized, placebo-controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of memantine and the University of Carolina (UNC)'s Get Real \& Heel cancer exercise program (MEM+EX) in addressing cancer-related cognitive impairment (CRCI) and underlying CRCI biomarkers. Ninety stage I-III breast cancer patients with mild cognitive difficulties during chemotherapy will be randomized into three groups: MEM+EX, memantine, or placebo. The study will evaluate recruitment, retention, adherence, acceptability, cognitive function, brain-derived neurotrophic factor (BDNF), inflammatory markers, and frailty at multiple time points.

RECRUITING
Music Improvisation Training on Cognitive Function in Older Adults
Description

This project will study the effects and mechanisms of a music improvisation training intervention on self-regulation of older adults with and without MCI. The investigator's overall hypothesis is that improvisation training will lead to improvements in self-regulation, compared to controls, and that improvisation training will be associated with specific changes in prefrontal brain networks and ultimately cognitive engagement.

RECRUITING
Cognitive Function in Rett Syndrome During Trofinetide Treatment
Description

Assessing cognitive functions among individuals with severe intellectual and developmental disabilities (IDD), including RTT, is often challenging due to floor effects of many standardized assessment batteries in this population. In addition, deficits in motor function and verbal ability may obscure certain abilities in this population when using standard IQ measures. Remote eye-tracking tasks have been proposed as an alternative approach for assessing cognitive functions among individuals with severe IDD, because eye-tracking tasks can be designed to minimize the influence of gross motor and receptive language deficits on performance. Although several types of eye-tracking tasks have been evaluated in RTT, most have been implemented only at a single time-point. As a result, it is unclear whether these measures are stable over time, or sensitive to developmental changes or alterations to health status that occur in RTT (e.g., developmental regression, development of seizures, change in medication, etc.). With the recent FDA approval of trofinetide for the treatment of RTT, we have a novel opportunity to test the sensitivity of eye-tracking and other psychophysiological measures to treatment changes. Anecdotally, parents and clinicians have reported improvements in attention and alertness during trofinetide treatment, but currently available outcome measures do not capture these types of effects. Therefore, we propose to conduct a pilot trial of changes in measures of attention, oculomotor function, learning, and autonomic function, all collected using non-invasive measures, during trofinetide treatment. This is an observational within-subject design with a 4-week post-treatment assessment compared to two pre-treatment assessments. Additional optional follow-up assessments will be performed with families who are interested and returning for standard-of-care visits to Gillette or who are willing to travel for a research-only visit.

Conditions
COMPLETED
Effects of Alpha-GPC on Muscle Power, GH Levels, and Cognitive Function
Description

Purpose: To determine the effects of low dose and high dose Alpha-GPC on cognitive performance, muscle performance, and serum growth hormone levels. Design: Randomized, three-arm, within-subject crossover Study Participants: 21 apparently healthy men to be recruited at a single investigational center in Northeast Ohio 4 Study Visits Study Visit 1: Participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet) Study Visit 2: Participants will ingest one of three supplements (a low dose α-GPC, a high dose α-GPC, or a placebo). Subjects will complete visual analog scale (VAS) questionnaires (assessing mood, motivation, alertness, and concentration) and a cognitive battery (Stroop, Flanker, and N-Back tests) 60 min post ingestion and approximately 3 hours post-ingestion, undergo upper body and lower body power testing and a lower body bout of moderate-intensity exercise 90 min post-ingestion. Also, subjects will undergo blood draws for levels of growth hormone at baseline (prior to supplementation) and 5, 15, 30, and 60 min post lower body bout of exercise. Vital signs and comprehensive side effect profile/ adverse event monitoring will take place throughout the duration of the study. The study will be conducted following ICH-GCP guidelines to ensure subject safety and scientific integrity of the data. Study Visit 3 and 4 Identical to visit 2 with exception of different supplementation being provided. Supplement administration was randomized using a Latin square approach to reduce variability and enhance statistical power Primary Outcomes: Upper and lower body peak force production, peak power production, and peak velocity Secondary Outcomes: Cognitive performance on the Stroop test, Flanker, and N-Back test, serum growth hormone levels, mood, motivation, alertness, and concentration (as assessed by visual analog scales). Tertiary/Safety Outcomes: Vital signs, side effect profile/AE monitoring

COMPLETED
The Investigators Conducted a Study to Examine the Impact of Wild Ginseng Extract (WG) on Exercise Performance, Cognitive Function, and Fatigue Recovery Among Twelve Healthy Adult Males
Description

The goal of this clinical trial was to learn if Wild Ginseng extract (WG) influences exercise performance, cognitive function, and fatigue recovery from the exercise. The main questions to answer were: * Does WG improve exercise performance? * Does WG improve cognitive function? * Does WG facilitate recovery from the exercise? The investigators will compare WG to a Placebo (a look-alike substance that contains no substance) to see if WG works. Participants will: * Take WG or a Placebo every day for 7 days with a 2-week wash-out (It is a specific time frame. During this time, certain substances are removed from the body). * Visit the laboratory a total of five times for the tests, including one pre-familiarization (to be familiar with the exercise and other procedures)

Conditions
RECRUITING
Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke
Description

Background: Stroke is the fifth leading cause of death in the United States. It is also a leading cause of disability. More than 70% of people who survive strokes have mental impairment or dementia. Medical factors, such as the severity of the stroke, affect whether a person will have mental impairment afterward. But social factors, such as education and ethnicity, seem to play a role as well. Researchers want to learn more about how social and lifestyle factors affect a person s chances of maintaining mental functions after a stroke. Objective: To better understand how social and lifestyle factors affect the risk of mental impairment after a stroke. Eligibility: People aged 18 years and older who had a stroke and a brain scan while they were enrolled in NIH Study 01N0007 (Natural History of Stroke Study). Design: Participants will have 1 study visit, by telephone. The call will last about 45 minutes. Participants will talk about their health since their stroke. They will answer questions about themselves. Topics will include: * Their race * Education * Ethnicity * Employment * Marital status * Residence address * Recent health history * Medical insurance They will have tests of their memory, attention, and language skills. They will repeat numbers and words forward and backward. Researchers will look at the data and imaging scans collected during participant s enrollment in NIH Study 01N0007. This data will include: * The hospital that first saw the participant at the time of their stroke. * The type of imaging that was first used then. * The primary diagnosis at admission. * Other medical details.

COMPLETED
A Clinical Trial to Evaluate the Efficacy of a Men's Supplement in Supporting Testosterone, Improving Cognitive Function, Mood, and Sexual Function
Description

This randomized, triple-blind, placebo-controlled, hybrid trial aims to evaluate the efficacy of a men's supplement designed to increase testosterone levels and improve energy, cognition, and sexual function. The study will involve 50 male participants, with assessments carried out at Baseline, Day 45, and Day 90 through questionnaires and blood tests.

ACTIVE_NOT_RECRUITING
A Clinical Trial to Investigate the Efficacy of a Supplement to Improve and Maintain Cognitive Function and Memory
Description

This study will evaluate the efficacy of 1MD Nutrition's MindMD supplement in improving and maintaining cognitive function and memory. The randomized controlled trial will include 50 healthy participants aged 50-75 years, lasting for 3 months. Participants will be randomized to receive either the test product or a placebo.

NOT_YET_RECRUITING
Impact of Yoga on Cognitive Function
Description

Mild cognitive impairment is highly prevalent in patients with heart failure and results in poor well-being and quality of life. While yoga has proven effective in promoting cognitive health in older adults through its gentle movements, controlled breathing, and meditation, its effects on patients with heart failure remain unknown. Therefore, this feasibility and pilot study plans to deliver a 12-week yoga intervention and test its effects on cognitive function in patients with heart failure and mild cognitive impairment.

RECRUITING
A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
Description

Up to 25% of intensive care unit (ICU) survivors experience cognitive impairment comparable in severity to mild Alzheimer's disease and related dementias after hospital discharge. Older ICU survivors (ages 60 and older) are at highest risk for delirium and subsequent cognitive impairment, which contribute to higher risk for cognitive decline related to Alzheimer's disease and related dementias. Sleep and activity are essential for recovery from critical illness, yet ICU survivors experience both sleep deficiency and profound inactivity. About 75-80% of ICU patients experience circadian dysrhythmia, which contributes to cognitive decline and increases likelihood of developing Alzheimer's disease and related dementias. The scientific premises of the proposed study are: 1) a combined sleep promotion and cognitive training intervention will have synergistic effects to mitigate the risk of cognitive impairment and development of Alzheimer's disease and related dementias in older ICU survivors; and 2) chronotherapeutic timing of interventions (i.e., adjusting timing of interventions according to circadian rhythm) may improve intervention efficacy.

RECRUITING
The Impact of Light Exposure on Cognitive Function in Classrooms
Description

Humans are constantly exposed to a variety of light types, created naturally or through artificial means. Light exposure captured by the eyes impacts many physiological functions in humans, including but not limited to cognitive output, fatigue levels, and mood regulation. The level of impact on cognitive learning from different types of light on undergraduate adult students remains unclear.

Conditions
RECRUITING
Radicle Clarity 24: A Study of Health and Wellness Products on Cognitive Function and Related Health Outcomes
Description

A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on cognitive function and related health outcomes

COMPLETED
Assessing Neurophysiological and Cognitive Function in School Children
Description

This trial will investigate the feasibility of implementing our novel assessment battery in a neurodiverse pediatric population. More specifically, we want to assess our processes and procedures with respect to 1) recruitment rate (i.e., efficiency of our recruitment methods), 2) tolerability (i.e., proportion of participants able to wear the hardware without difficulty), 3) compliance (i.e., proportion of participants able to complete each task as instructed), 4) efficiency (i.e., time to completion of the test battery), and 5) data fidelity (i.e., proportion of test acquisitions with data suitable for subsequent analyses).

Conditions
TERMINATED
Serial Testing To Assess Cognitive Function In Cancer
Description

The purpose of this study is to examine the effects of immunotherapy on cognitive function of cancer patients and follow them clinically over a period of six months with the Montreal cognitive assessment (MoCA) to assess changes in cognition.

Conditions
RECRUITING
AvoCog - the Effect of Daily Avocado Intake on Cognitive Function in Older Adults
Description

The goal of this clinical trial is to determine if adding avocados to the diet of impacts cognition in 70 older adults, age 65-85, without dementia. We will test for change in functional MRI, cognitive performance, and brain blood flow. Intervention group participants will be asked to consume 1 avocado per day for 12 weeks. Participants in the control group will be asked to continue their normal intake for 12 weeks. Throughout the study, participants will be asked to perform cognitive tests, MRI, blood tests, and questionnaires.

Conditions
RECRUITING
Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV
Description

People aging with HIV are at higher risk for Alzheimer's disease and related dementias, and although physical activity is a promising target to mitigate such risk, this population engages in low levels of physical activity. Few studies have tested cognitive effects of exercise interventions or examined mechanisms of adherence to long-term exercise among diverse samples of midlife and older people with HIV. The current study will leverage an existing R01 to address these gaps and provide implications for development of personalized approaches for the treatment and prevention of cognitive impairment and dementia in older people with HIV.

COMPLETED
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of LasoperinTM on Cognitive Function in Healthy Adults
Description

The potential impact of various dietary ingredients to improve cognitive function, mood, well-being, and overall levels of affects are largely undetermined. The purpose of this study is to determine the effects of a combination of two dietary supplements, Scutellaria baicalensis and Acacia catech, on cognitive function, well-being, mood, cognitive interferences, and inflammation.

RECRUITING
SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease
Description

The purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with PD. This project is a proof-of-concept study to assess the effectiveness of postural training using Segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training.

COMPLETED
Impact of Musical Improvisation Training on Cognitive Function in Older Adults
Description

This project will develop and test the effects and mechanisms of a music improvisation training intervention on self-regulation of older adults with and without MCI. The investigator's overall hypothesis is that improvisation training will lead to improvements in self-regulation, compared to controls, and that improvisation training will be associated with specific changes in prefrontal brain networks and ultimately cognitive engagement.

COMPLETED
Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
Description

The purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline. In a double blind, randomized manner, 40 free living males and females between 55 to 75 years with age-associated memory decline will ingest Brainphyt supplement or Placebo for 12 weeks. Cognitive function battery will be realized after 4 and 12 weeks of supplementation.

RECRUITING
The Effects of Specialty Coffee on Cognitive Function in People With Type 2 Diabetes
Description

Coffee has been found to have beneficial effects on cognitive function and blood sugar control. Benefits include reduced risk of cognitive decline and improved performance on cognitive tests, as well as reduced risk of diabetes and improved blood sugar control in people with diabetes, a population that is at a higher risk of cognitive decline. These effects have been observed for both caffeinated and decaffeinated coffee, and have been associated with the polyphenol chlorogenic acid (CGA). This polyphenol has been found to be more bioavailable in certain coffees, known as "speciality coffee" as defined by the Specialty Coffee Association of America, depending on agriculture, roasting, and brewing method. This current project will bring together these previous findings to explore the effects of specialty coffee on cognitive function and glycaemic control in people with type 2 diabetes through a randomized control trial with two groups: a high CGA specialty coffee group and a conventional coffee control group. Participants will be quasi-randomly assigned to one of these two groups following the completion of a 4-week run-in period during which participants will consume conventional coffee only. The length of the experimental arms is 8 weeks, therefore the total length of the study is 12 weeks. At the beginning and the end of each experimental arm participants will undertake a cognitive assessment online using the Gorilla platform, and a series of questionnaires relating to health and mood measures (details in procedure). Cognitive function will also be assessed at the beginning of the 4-week run-in period.

Conditions
TERMINATED
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
Description

The aims of this proposal are to: 1) investigate whether individuals with spinal cord injury (SCI) demonstrate cardiac autonomic, cerebrovascular, and cognitive dysfunctions compared to non-injured age- and sex-matched controls in the following conditions: supine rest and head-up tilt/face-cooling test; 2) examine if autonomic completeness/ incompleteness, physical activity, and psychological distress are predictors for dysfunctions during supine rest and head-up tilt/face cooling conditions in SCI individuals; 3) examine if one bout of moderate-intensity aerobic exercise temporarily improves cardiac autonomic and cerebrovascular functions and thereby improves cognition when in supine rest and head- up tilt/face cooling conditions. The study will include an initial visit and an experimental visit to our lab. Three groups of participants will be included in this study: Group 1, SCI with acute exercise; group 2, SCI with rest-control; and group 3, age- and sex-matched non-injured individuals. Cardiovascular variables, such as heart rate variability, blood pressure variability, and cerebrovascular variables, such as cerebral blood flow velocity and oxygenated hemoglobin, and cognitive performance will be examined. The investigator hypothesizes that individuals with SCI will have impaired cardiac autonomic, cerebrovascular, and cognitive functions compared to the non-injured controls, and an acute exercise can improve those functions. Autonomic completeness/incompleteness, physical activity, and psychological distress are significant factors that predict cardiac autonomic, cerebrovascular, and cognitive functions in individuals with SCI.

COMPLETED
The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function
Description

VisionPure™ is a softgel dietary supplement containing fish oil, lutein, zeaxanthin, and vitamin D. The intent of the VisionPure product is to assist in maintaining eye and cognitive health while helping to provide protection against blue throughout the day. In this pilot trial, approximately 16 participants will be recruited and randomly assigned to experimental and placebo conditions. Participants will consume 1 serving (2 softgels) per day of their respective study condition for 60 days. Prior to and following the 60 day supplementation period, participants will undergo a series of optometry and cognitive examinations to quantify eye health and cognitive function outcomes.

COMPLETED
Nitrate Supplementation and Cerebrovascular and Cognitive Function in Metabolic Syndrome
Description

The purpose of this study is to determine if beetroot juice consumption can improve cognitive performance and brain vascular function in individuals with metabolic syndrome