Clinical Research Directory

Fall Prevention in Mild Cognitive Impairment

Falls represent the leading cause of hospitalization, nursing home admissions, disability and mortality for older adults with annual healthcare costs over $50 billion. Older Veterans with cognitive impairment are at an increased risk of falls and injurious fall. The purpose of this study is to test the effects of 6 weeks of a virtual tele-neurorehabilitation intervention on fall prevention, functional mobility, strength, cognition and performance of activities of daily living. Participants will be one of 28 participants in the VA Maryland Health Care System. Participation in the study is voluntary and the research will be conducted at the VA Maryland Health Care System. The entire study will take approximately 2 years to complete. Subject's participation in the study will last 3 months.

Cognitive Assessment And Post-Operative Complications After Surgery: Linking Anaesthesia And Risk

Many older people can experience confusion, memory problems, or a decline in their thinking after major surgery. These problems are sometimes called 'postoperative neurocognitive disorders' or PND and can affect recovery and a person's ability to live independently. The investigators want to find out the best way to study these problems in older patients undergoing surgery. This is a 'feasibility study', which means we are testing the research methods. The investigators want to see if it is possible to ask participants to do memory tests and give blood samples before and after their operation. The investigators are hoping to include around 40 patients over 2 years in this study. The investigators will compare performance in memory (cognitive assessment) findings before and after surgery and link this to data taken from the anaesthetic, including the types of drugs used, duration, brain features from processed electroencephalogram monitoring and standard recommended monitoring. In addition the investigators will link this to blood sample markers of brain health and function (biomarkers). The results of this study will help the investigators plan a much larger study in the future, with the ultimate goal of making surgery safer for the brain.

Cognitive Task-Based Walking Effects on Cognition, Mood, Sleep, and Quality of Life in Older Adults With Brain Fog

This randomized controlled trial aims to investigate the effects of cognitive task-based walking exercise on cognitive function, depressive symptoms, sleep quality, and quality of life in older adults experiencing brain fog. Eligible participants will be randomly assigned to either a cognitive task-based walking exercise group or a walking-only exercise group. The intervention will be conducted under physiotherapist supervision, three times per week for four weeks. Outcome measures will be assessed at baseline and after the intervention period to compare the effectiveness of the two exercise approaches.

A Sitting Tai Chi Programme for Chronic Stroke Survivors With Post-stroke Cognitive Impairment

Introduction Stroke remains the third leading cause of death and disability combined. Post-stroke cognitive impairment (PSCI) is a common neurological sequela that may affect up to 80% of stroke survivors. Several systematic reviews and studies indicated that Tai Chi benefits patients with mild cognitive impairment, leading to significant improvement in cognitive function. Our previous study adopted a tailored sitting Tai Chi programme for the rehabilitation of subacute stroke survivors without any cognitive impairment. The results of the randomised controlled trial (RCT) showed that upper limb function, balance control, ADL, depressive symptoms, and QoL were significantly improved compared to the control group. To better understand the usefulness of the sitting Tai Chi programme for chronic stroke survivors with cognitive impairment and how it might affect other rehabilitation outcomes, this study was proposed to examine its feasibility and preliminary effectiveness. Methods An outcome assessor-blinded RCT will be conducted. Participants will be randomised with a 1:1 allocation ratio to either the intervention group or the waiting list control group. A total number of 88 dyads (176 participants) including 44 stroke survivors and 44 caregivers will be recruited in each group. For the qualitative part, a purposive sample of 30 stroke survivors with low, medium and high satisfaction scores will be invited. Intervention Sitting Tai Chi group: Participants in the sitting Tai Chi group will receive 12 weeks of 10-form sitting Tai Chi exercise training with a frequency of three days a week and 40 minutes a day, including 5 minutes warm-up, 30 minutes Tai Chi training, and 5 minutes cool-down. A registered nurse (RN) with experience with Tai Chi training and who participated in our previous study will lead the training session. The RN will receive refresher training in sitting Tai Chi and learn the basics about the condition of PSCI and the characteristics of survivors with PSCI. Control group: Participants in the control group will receive usual care. That is, regular inpatient treatment and care, without additional rehabilitation treatment. At the end of the intervention follow-up assessment, they will be invited to participate in the sitting Tai Chi exercise led by the same nurse as well. Assessment and measurement Primary outcomes include cognitive function, upper limb function, balance control, and depressive symptoms. They will be assessed at baseline, eight weeks, and 12 weeks after the commencement of the sitting Tai Chi training by validated scales. 1. Cognitive function will be measured using the MoCA scale. 2. Upper limb function will be measured using Fugl-Meyer Test Upper Limb section and Wolf Motor Function Test 3. Balance control will be measured using the Berg Balance Scale and the Trunk Impairment Scale 4. Depressive symptoms will be measured by the 15 items Geriatric Depression Scale short form. 5. The Modified Barthel Index will be used to assess ADL. 6. QoL will be assessed using the Chinese version of Stroke-Specific Quality of Life Scale. Feasibility and Acceptability This pilot RCT evaluates the feasibility of the sitting Tai Chi programme. Feasibility is evaluated based on recruitment and retention rates from baseline to follow-up. All participants will be invited to fill in a satisfaction survey with the sitting Tai Chi programme and the usefulness of its components. Satisfaction A self-developed User Satisfaction Questionnaire (USQ) will be used to assess stroke survivors' satisfaction in terms of usability, acceptability, and applicability. Adverse events measurements Any unexpected adverse events during the intervention period will be monitored. Semi-structured interview We will conduct semi-structured in-depth interviews using a pre-designed semi-structured interview guide. Ethical considerations Ethical approval will be applied from the Joint Chinese University of Hong Kong- New Territories East Cluster Clinical Research Ethics Committee and the study hospital's research ethics committee. Written consent will be obtained from the eligible participants. Data collection, consent, and sample storage A sociodemographic and clinical data sheet will be used to record the corresponding information. The research assistants will screen potentially eligible participants by daily reviewing the medical records of all stroke survivors admitted to the study venues. Data processing and analysis Statistics analysis will be conducted using the IBM SPSS version 29.0. All primary analyses will be conducted on an intention-to-treat basis. Descriptive statistics will be used. A generalized estimating equations (GEE) model will be employed to compare differential change of each of the primary and secondary outcomes across the study time points between the two groups. Content analysis will be used to analyse the qualitative data from the participants.

Tele-Rehabilitation vs Conventional Rehabilitation for Cognitive Improvement in Stroke Survivors.

This study aims to: * Compare tele-rehabilitation and conventional rehabilitation for cognitive improvement after stroke. * Evaluate changes in cognitive function using standardized assessment tools. * Determine whether tele-rehabilitation is as effective as conventional therapy. * Improve evidence-based rehabilitation strategies for stroke survivors.

Efficacy of Spectrally Optimized Light on Cognitive Impairment in Major Depressive Disorder and Its Neuroimaging Mechanisms

This study aims to validate the therapeutic efficacy and safety of spectrally optimized light (SOL) in ameliorating cognitive impairment (CI) in major depressive disorder (MDD), characterize the functional and structural features of the hippocampus （HPC）-dorsolateral prefrontal cortex （dlPFC） neural circuitry in MDD patients with cognitive impairment and examine the mediating effect of the HPC-dlPFC neural circuit on the cognitive improvements induced by SOL treatment in MDD-CI patients. Patients with MDD-CI are required to only receive selective serotonin reuptake inhibitors (SSRIs) as primary medication for at least one week or not do anything treatment before. SOL is a kind of Bright Light Therapy(BLT). Qualified participants will be randomly assigned to the experimental group and the control group. The experimental group will receive the intervention of BLT, and the control group will receive the intervention of dim red light (placebo). The intervention will last for four weeks. The participants will be followed once in a week during intervention and in 4th week after intervention. Demographic information will be collected at baseline, cognitive function will be evaluated at baseline, 2nd, ,4th and 8th weekends after intervention beginning. and other symptoms such as depression, anxiety and sleep were assessed at baseline, 1st, 2nd, 3rd ,4th and 8th weekends after intervention beginning.Moreover, structural and functional MRI scans will be made at baseline and after four weeks intervention. During intervention, patients with MDD-CI will keep a record of daily light exposure duration, complete the daily sleep diary as well.

The Care for America's Aging Study

Care for America's Aging is a randomized pilot study investigating whether a home health aide training intervention consisting of enhanced dementia-specific curriculum content will improve: 1) behavioral symptoms of older adult persons living with dementia or cognitive impairment (PLWD/CI) and 2) global health-related quality of life among PLWD/CI and their care partners.

intErnet-based iNterventions FOR Cardiac arrEst suRvivors

This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster Health Related Quality of Life in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms

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.

Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial

Our study intends to offer 'real world' evidence of a viable, sustainable means to mobilize primary care via a comprehensive strategy for detecting cognitive impairment and dementias, advancing next steps for referral, and participating in the care planning and management of affected patients and caregivers. We will conduct a clinic-randomized, pragmatic trial testing the effectiveness and fidelity of our NIH Toolbox-derived paradigm to improve early detection and management of cognitive impairment/dementia in primary care settings serving health disparate patient populations.

Cognitive Rehabilitation in Post-stroke Cognitive Impairment

The goal of this 2-year, prospective, single-blind randomized clinical trial is to investigate: the efficacy in reducing the risk of cognitive impairment 6 months after stroke; the generalizability of cognitive reinforcement to real life, such as activities of daily living and quality of life; and the impact on cognitive performance. In the treatment group, feasibility, adherence, and satisfaction with the cognitive telerehabilitation program will also be evaluated. Participants will be adult patients with a diagnosis of ischemic or hemorrhagic stroke, within 5-21 days after onset. The main outcomes to be evaluated are: * diagnosis of cognitive impairment (primary outcome); * activities of daily living, quality of life, changes in frailty status, and cognitive efficiency (secondary outcomes). There will be two groups: a treatment group and a control group. Participants in the treatment group will undergo a cognitive telerehabilitation program of 40 hours over 8 weeks, while participants in the control group will be instructed to follow their standard care.

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.

A Modified Test of Goal-directed Behaviour: a Feasibility Study

Cognitive assessment plays an important part in decision making in acute neurological settings, partly because difficulties with cognitive skills such as attention, memory and executive functioning (which includes planning and problem-solving) have direct implications for patents' levels of independence and safety upon discharge. A bedside cognitive task that could shed light upon a patient's ability to demonstrate effective goal-directed behaviour (potentially along with other aspects of executive functioning such as cognitive flexibility) would be a useful addition to the existing repertoire of bedside cognitive assessments. One such test could be 'Link's Cube'. The Link's Cube Test is impractical for bedside use in an acute ward setting, as it comprises 27 small blocks. The feasibility study aims to preserve the information that is provided by Link's Cube Test (i.e. an indication of the patient's ability to engage in goal-directed behaviour) whilst altering the testing material such that only nine, slightly larger blocks are used. The objectives for the feasibility study are: * To identify any practical difficulties in administration of the tests that may not be apparent without trialling them * To generate information regarding the timing and sequence of overall administration and in particular the proposed modified Link's Cube test * To obtain feedback from neuropsychologists about ease of administration of the proposed new test and to obtain their views regarding potential benefits

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?

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.

Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease

The purpose of this study is to determine if patients with sickle cell disease (SCD) can consistently take a drug called Methylphenidate (MPH) daily, once a day for 4 weeks to help with any thinking, attention or schoolwork problems and if they have any side effects. The study will assess any thinking or attention problems participants may have both before taking this drug and after. Additionally, the study will assess the decision-making process of the caregiver that may influence using this drug or not. Primary Objective: • Assess the feasibility, acceptability, and adherence to MPH treatment in children with SCD and EF deficits. Secondary Objective: • Evaluate neurobehavioral and safety outcomes following MPH treatment. Exploratory Objective: • Evaluate decision-making and determinants influencing methylphenidate utilization among parents.

Music Improvisation Training on Cognitive Function in Older Adults

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.

Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT

This is a phase I, dose-escalation and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and tolerability of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT). This study will investigate whether NAC will mitigate chemotherapy-related cognitive impairment (CRCI).

Remote Ischemic Conditioning for Cognitive Impairment in Cerebral Small Vessel Disease

This randomized, double-blind, sham-controlled trial aims to evaluate the effect of remote ischemic conditioning (RIC) on cognitive function in patients with cerebral small vessel disease-related mild cognitive impairment. Forty eligible participants will be randomized 1:1 to receive either RIC or sham RIC twice daily for 90 days in addition to standard medical therapy. The primary outcome is the change in Montreal Cognitive Assessment (MoCA) score from baseline to 90 days. Secondary outcomes include changes in white matter hyperintensity burden and diffusion tensor imaging metrics on MRI, EEG functional connectivity, and activities of daily living.

Remote Game-based Exercise Program for Cognitive and Motor Function Improvement

As our population ages, more older adults face motor-cognitive declines, increasing their risk of falls and fear of falling. Exercise is an effective way to maintain cognitive function, as supported by recent studies. However, those with poor motor and cognitive abilities often struggle to visit rehabilitation centers, leading to high dropout rates and low adherence to unsupervised programs. A remote exercise program tailored for individuals with cognitive impairments is urgently needed to preserve cognitive function, promote independent living, and reduce related costs. Researchers aim to develop an in-home system for adults with mild cognitive issues or dementia, designed to improve balance and cognition while being remotely supervised through telemedicine.

Visual Frailty in Ageing

The goal of this observational study is to define visual frailty and refine monitoring for an ageing population. It involves piloting a visual frailty assessment tool in a cohort of patients aged 60 and above with a known diagnosis of Age-related Macular Degeneration (AMD) in Princess Alexandra Eye Pavilion (PAEP), Anne Rowling Clinic which is hosting the NHS Low Visual Aid Clinic, or any other NHS Lothian facility treating patients with Age-related Macular Degeneration (AMD). The main questions it aims to answer are: * What is visual frailty and how can it be assessed or predicted in the global ageing population using visual acuity, reading performance, functional status, mental health and systemic co-morbidities? * What is the relationship between visual acuity, reading performance, ocular diagnosis, co-morbidities, mental health, and functional status? Participants will have the following data collected from them from either Princess Alexandra Eye Pavilion, Anne Rowling Clinic which is hosting the NHS Low Visual Aid Clinic, or any other NHS Lothian facility treating patients with Age-related Macular Degeneration (AMD): * Visual acuity (both distance and near) * Reading performance * Functional status * Mental health * Co-morbidities Data will also be collected remotely (by phone call) from both the participants and their carers/relatives about their perceptions of visual frailty. Expert opinion will be sought from optometrists and ophthalmologists about the concept of visual frailty using an online survey.

A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia

Schizophrenia is a long-lasting and serious mental health disorder that affects about 1% of people worldwide. It can cause symptoms such as hallucinations and delusions (called positive symptoms), confused or disorganized thinking, reduced motivation and emotional expression (negative symptoms), difficulties with memory and concentration (cognitive symptoms), and movement problems like restlessness or slowed activity. Current treatments, called antipsychotics, mainly work by blocking dopamine in the brain. These medicines are helpful for hallucinations and delusions, but they do little to improve negative or cognitive symptoms. A new medicine, Xanomeline/Trospium (XT), works differently. It targets a brain system called the muscarinic acetylcholine receptors while limiting side effects elsewhere in the body. Clinical trials have shown that XT reduces psychotic symptoms effectively and is generally well tolerated. The FDA approved XT in 2024 for adults with schizophrenia. Importantly, early results also suggest that XT may help improve thinking and memory (cognition domains), though this has not yet been studied in depth. Most schizophrenia drug studies pay little attention to long-term changes in cognition, often using only short screening tests. This study will be the first to take a deep look at cognitive function over a full year of XT treatment. It will also examine how changes in thinking skills connect with other aspects of life, such as symptom control, daily functioning, and quality of life. By making cognition a central outcome, the study responds to an urgent need in schizophrenia research: moving beyond just controlling hallucinations and delusions toward improving real-world recovery. The results could help shape future treatment strategies and support the idea that cognition should be a core treatment target in schizophrenia.

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques

Establish a novel vocational training program and test its validity in a pilot study.

Cognitive Remediation Intervention to Prepare for Transition of Care

Randomized Controlled Trial (RTC) testing the efficacy of a telehealth adaptation of the Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention to prepare adolescents with sickle cell disease for transition of care.