Clinical Research Directory

Cognitive Remediation for Social Cognition in Schizophrenia and Related Disorders

This study will investigate whether the remote administration of the cognitive remediation program RC2S+ acceptable and feasible in people with schizophrenia and related disorders.

NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia

This study will examine brain metabolic and excitatory/inhibitory mechanisms related to cognitive and visual functioning in adults with schizophrenia and healthy control participants. Participants will complete behavioral assessments, cognitive testing, electroencephalography, magnetic resonance imaging, and magnetic resonance spectroscopy assessments. After baseline assessments, participants will be randomly assigned to one of two computerized cognitive training programs: perceptual discrimination training or cognitive control training. Each training program will include approximately 10 hours of training over 2 to 6 weeks. The study will evaluate changes in cognitive and visual task performance, EEG measures, and brain metabolite concentrations before and after cognitive training. Some participants may also complete optional extended baseline assessments before cognitive training.

Scaffolding in AI-Empowered Cognitive Training Improves Outcomes in Cognitive Impairment

This retrospective study aimed to validate and compare two individualized, closed-loop, AI-driven computerized cognitive training programs with a conventional non-AI training program in a real-world clinical setting. Using objective tablet-recorded data from patients' prior treatment, participants were categorized into three groups according to the training recommendation strategy they actually received. Changes in global cognitive function and specific cognitive domains after 8 weeks of training were compared across groups to evaluate the association between different training strategies and cognitive outcomes.

COgnitioN With VERiciGuat Evaluation in Heart Failure

CONVERGE-HF is a 4-center pilot phase IIb randomized control trial in ambulatory patients with chronic heart failure (≥ 6 months) and mild-to-moderate cognitive impairment.

Comparative Evaluation of Immediate vs Progressive Standing Dual Task Training in Elderly With Mild and Moderate Cognitive Impairment

older adults with mild and moderate cognitive impairment. compare immediate vs progressive standing dual-task training. assess balance, cognition, executive function, mobility, and quality of life.

Effects of Hyperbaric Oxygen Combined With Aerobic Exercise on Working Memory Among Stroke Patients

This single-center randomized controlled trial enrolled stroke patients with working memory impairment. Participants were randomly divided into the hyperbaric oxygen combined low-intensity focused ultrasound intervention group and the conventional rehabilitation control group. The intervention lasted for a fixed course, and indicators including working memory performance and prefrontal cortex activation detected by fNIRS were compared before and after treatment. The study aims to verify whether combined intervention can better improve cognitive function in stroke survivors. All subjects signed informed consent and obtained ethical approval before enrollment.

A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD

The purpose of the study is to examine the effect of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression and pain-related disability in 100 older adults with cognitive impairment, chronic pain, and depression. The study will test if PATH-Pain has better cognitive, affective, and functional outcomes than Attention Control Usual Care.

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)

We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral hemodynamic perfusion in a hemodynamically impaired subset of the CREST-2 -randomized patients. We will enroll 385 patients from CREST-2, all of whom receive cognitive assessments at baseline and yearly thereafter. We anticipate identifying 100 patients with hemodynamic impairment as measured by an inter-hemispheral MRI perfusion "time to peak" (TTP) delay on the side of stenosis. Among those who are found to be hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at baseline and at 1 year will determine if those with flow failure who are randomized to a revascularization arm in CREST-2 will have better cognitive outcomes than those in the medical-only arm compared with this treatment difference for those who have no flow failure. We hypothesize that hemodynamically significant "asymptomatic" carotid disease may represent one of the few examples of treatable causes of cognitive impairment. If cognitive decline can be reversed in these patients, then we will have established a new indication for carotid revascularization independent of the risk of recurrent stroke.

ME/CFS Brain Fog: Cognitive Rehabilitation Trial

The purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Most of the procedures will take place over a phone call or secure telehealth platform (i.e., Zoom). However, participants will be asked to visit UAB on three occasions for blood sample collection and brain imaging (about 2 hours each). Online testing will happen one month before treatment, one day before treatment, one day afterwards, and 6 months afterwards. The study will utilize two different forms of rehabilitation training to improve participants' cognitive ability. Participants will be randomized to one of the two treatment groups. The first treatment approach, known as Constraint-Induced Cognitive Therapy (CICT), will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) online training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation, also known as trans-auricular VNS (taVNS). The second approach, known as Brain Fitness Training (BFT), will include (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, breathing, healthy nutrition, and healthy sleep, (C) education about how relaxation, breathing, nutrition, and sleep are connected to thinking effectiveness, and (D) taVNS. Approximately 30 hours of training will be conducted over a secure telehealth platform (i.e., Zoom) in the span of two- to four- weeks. A typical CICT session will consist of one hour of gaming, with the bulk of the session being spent on cognitive training of the target behaviors and procedures designed to promote transfer of therapeutic gains to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. A typical BFT session will consist of one hour of gaming, training on healthy lifestyle behaviors (i.e., healthy sleep, nutrition, and relaxation habits), as well as procedures designed to promote transfer of behavior changes to daily life. Ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. Training sessions in both conditions will be scheduled based on participants' availability, with the options for sessions scheduled to be as close as every weekday over 2 weeks or as loosely as every other weekday (i.e., over a 4-week span). If a caregiver is available, they will receive training on how to best support participants in their therapeutic program. After the training ends, both groups will receive 4 follow-up phone calls approximately one week apart to promote integration of the gained skills into everyday life. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.

Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance

The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users.

Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients

Elevated blood pressure (BP) consists of a major public health concern especially in low and middle income countries. Besides being a highly prevalent condition, it is also a risk factor for several major cardiovascular events including stroke (which consists of the second leading cause of death in developing countries) and coronary artery disease, and is also related to cognitive decline. The OPTIMAL Stroke trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower target systolic blood pressure (SBP) as compared to the currently recommended target for stroke patients will reduce the occurrence of major cardiovascular events.

Choline to Improve Malnutrition and Enhance Cognition

The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi. The main question it aims to answer is: \- Will the addition of a 500mg daily dose of choline to RUTF during treatment for SAM improve cognitive development among 6-59-month-old Malawian children compared with standard RUTF without added choline?

Multimodal Assesment of Alzheimer Patients

The goal of this study is to learn more about the changes in the brains of patients with cognitive impairment (MCI) and Alzheimer's Disease (AD). The main questions the study aims to answer are: 1. What findings can be used to earlier detect patients that will develop Alzheimers? 2. Which differences are seen between healthy and cognitively impaired patients? 3. Which differences are seen between patients with Alzheimers disease? Participants will undergo: * Cognitive tests * Magnetic resonance imaging (MRI) * Electroencephalography (EEG) * Blood sample collection * Fecal sample collection * A randomized group will undergo polysomnography analysis.

Early Age-Related Hearing Loss Investigation (EARHLI)

Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD).

Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment

This RCT design will enroll 256 informal caregivers (spouse/partner or child) of HHC patients with HF/CI and 60 patients with HF and mild to moderate CI (60 dyads). After collecting baseline data, we will block randomize the caregivers 1:1 to the ViCCY intervention or comparator group, stratifying randomization by caregiver sex (male/female), relationship (spouse/partner or child), and race (white/other)- factors known to influence caregiving burden, perceived stress, and receptivity to the intervention. We will encourage caregivers to use their own devices but provide tablet devices with wireless network access if needed. The intervention group will receive 10 sessions of ViCCY over 6 months.

The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study

A study in Finland found that a multidomain intervention of physical activity, nutritional guidance, cognitive training, social activities and management of vascular risk factors slowed cognitive decline in healthy older adults at increased risk of cognitive decline. A 6-month pilot study was initiated in Singapore, which demonstrated the cultural feasibility and practicality of the FINGER interventions and a set of locally adapted interventions in an Asian population. The SINGER study is a 2-year randomized controlled trial that aims to test the efficacy and safety of these lifestyle changes, including diet and cardiovascular risk factor management, cognitive and physical exercises, in delaying cognitive decline in older adults at risk of dementia.

TDCS to Improve Post-Stroke Cognitive Impairment

The investigators will conduct a randomized, double-blinded, sham-controlled trial of approximately 60 patients with minor stroke and post-stroke mild cognitive impairment (psMCI). Participants will be individually randomized on enrollment using a random number generator to treatment with anodal tDCS + computerized cognitive treatment (CCT) versus sham + CCT (approximately 30 patients in each arm). Clinical evaluation including assessment of cognition will be performed pre- and post-intervention by individuals on the study team blinded to the participant's intervention. Participants will also undergo functional neuroimaging with magnetoencephalography (MEG) pre- and post-intervention (1, 3, and 6 months post-stroke to evaluate for initial and longer-term effects of treatment on cerebral activation patterns and functional connectivity). Neuroimaging and clinical outcomes will be assessed to determine the effect of tDCS versus sham + CCT on psMCI.

Anticipating Decline and Providing Therapy

This pilot feasibility study will be a randomized control trial of usual care following Intensive Care Unit (ICU) discharge compared to the Anticipating Decline and Providing Therapy (ADAPT) screening and support intervention. The trial aims to enroll 120 older adults (age 60 or older).

Mind Your Heart-II

This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.

Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES)

High blood pressure (BP) is a major public health concern, especially in low and middle income countries. High BP is a highly prevalent condition, and it is usually associated with diabetes mellitus. Both high BP and diabetes are risk factors for major cardiovascular events including cardiovascular death, acute myocardial infarction, stroke, unstable angina and heart failure. In addition, high BP is also related to cognitive decline. The OPTIMAL-DIABETES trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower systolic blood pressure (SBP) target will reduce the occurrence of major cardiovascular events in diabetic patients compared to the standard SBP target.

A Clinical Trial to Evaluate the Effects of a Supplement on Cognitive Performance

This study evaluates the effects of the Xula Herbs Mind Food supplement on cognitive performance in adults aged 25-70 who report difficulty concentrating, memory challenges, brain fog, and low productivity. The trial is a single-arm, open-label, virtual study conducted over 6 weeks in 35 participants. Participants will use the test product three times daily (sprayed three times under the tongue, at least 30 minutes before a meal, and not after 6 pm) for the duration of the study. Cognitive performance will be assessed via a Cognitive Battery Test at Baseline and Week 6, and self-reported questionnaires will be completed at Baseline, Week 2, Week 4, and Week 6.

Living Independence Through Functional Training

The purpose of the research is to evaluate the feasibility and benefits of a six-week hybrid task-oriented resistance exercise program for older adults who have been recently discharged from home health care.

Structural and Clinical Predictors of Cognitive Impairment After Surgical Treatment for Ruptured Cerebral Aneurysms

This study investigates the clinical and structural predictors of long-term cognitive impairment in patients who underwent microsurgical clipping for aneurysmal subarachnoid hemorrhage. Using a retrospective cohort with prospective neuropsychological and MRI assessments, it aims to identify factors associated with late cognitive deficits and improve prognostic stratification, rehabilitation planning, and long-term patient care.