Clinical Research Directory

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.

GLP-1 Analogue in Preventing Progression of Small Vessel Disease (GAPP-SVD)

Cerebral small vessel disease (cSVD), a result of neurovascular cell dysfunction, is a major cause of stroke, dementia and mobility problems worldwide. Vascular risk factor control alone may not be sufficient to prevent the development of vascular cognitive impairment (VCI) in patients with cSVD according to previous clinical trials. The presence of glucagon-like peptide-1 receptor (GLP-1R) in cerebral microglia may reveal a potential therapeutic target for prevention of cSVD progression and its disabling clinical outcomes. At the cellular and animal experimentation levels, GLP-1R agonist demonstrated reversal of some pathogenic processes in cSVD. However, its application to cSVD patients remains to be elucidated. Investigator aims to investigate the safety and efficacy of GLP-1R agonist in patients with moderate-to-severe cSVD.

Neural Correlates (EEG and fMRI) of Gait in Small Vessel Disease

What is the purpose of this study? This observational study is being done to understand how cerebral small vessel disease (SVD) affects walking and balance. SVD is a common brain condition in older adults that damages small blood vessels. It can lead to problems with movement, thinking, and memory. The researchers want to find out how changes in brain activity and connectivity contribute to walking difficulties in people with SVD. Why is this study important? Walking and balance problems increase the risk of falls and loss of independence. By studying brain activity during walking-related tasks, researchers hope to identify patterns that explain why these problems happen. This knowledge could help develop better rehabilitation methods in the future. Who can participate? Adults over 50 years old with cerebral small vessel disease and gradual gait problems may be eligible. Healthy adults of similar age without neurological problems may also take part as control participants. What will happen in this study? Participants will: Complete walking, balance, and cognitive tests such as the Timed Up and Go, Berg Balance Scale, and Montreal Cognitive Assessment. Undergo brain imaging (MRI) to confirm the diagnosis and study brain structure and function. Have an EEG recording while resting and while watching short videos showing walking and turning movements. A smaller group will also undergo functional MRI (fMRI) while watching the same videos. The MRI and EEG results will be analyzed to see how brain networks involved in movement and balance differ between patients and healthy adults. How long will the study take? The study will take about two years to complete. Each participant's visit will last approximately two to three hours in total. What are the possible benefits? There may be no direct benefit to participants. However, this study may help researchers understand how small vessel disease affects brain function related to walking, which may improve care for future patients.

Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort. SHIVA-CogNeurophys

Cerebral small vessel disease (cSVD) is characterized by an alteration of the structure and function of small penetrating brain arteries. Highly prevalent in older individuals from the general population, it represents a leading cause of stroke and a major contributor to cognitive decline and risk of dementia. Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. The aim of the present study is to identify novel electroencephalographic (EEG) biomarkers of the cognitive deficits associated with cSVD, and how these biomarkers and cognitive performance are affected by personalized cognitive training or transcranial alternating current stimulation (tACS), a non-invasvie brain stimulation technique.

VR Training to Improve Postoperative Cognitive Function in Elderly Patients With Cerebral Small Vessel Disease Undergoing Non-Cardiac Surgery

This clinical study aims to investigate whether virtual reality (VR)-based cognitive training can help improve postoperative cognitive function in elderly non-cardiac surgery patients with pre-existing cerebral small vessel disease (CSVD). As the global aging population undergoes an increasing number of surgical procedures, perioperative neurocognitive disorders (PND) have emerged as a serious complication among surgical patients, potentially prolonging hospital stays and increasing the risk of developing Alzheimer's disease. The study employs an innovative VR system that integrates eye-tracking cognitive assessment with interactive rehabilitation games to evaluate and train patients' cognitive function prior to non-cardiac and non-cranial surgeries. Conducted at Peking University Third Hospital, Peking University First Hospital, and Xuanwu Hospital of Capital Medical University, this research specifically targets patients undergoing general surgery, orthopedic surgery, and other non-cranial/non-cardiac procedures. It seeks to validate whether this technology-based intervention can effectively enhance postoperative cognitive function in this population while exploring its underlying mechanisms. The findings may offer a practical solution for protecting cognitive health in elderly patients during recovery from routine surgical procedures.

Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease

This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in patients with acute ischemic stroke due to small vessel disease (TASTE-SVD). The study will enroll approximately 600 participants aged 30 to 80 years who have experienced a recent small subcortical infarct (RSSI) confirmed by MRI. Participants will be randomized in a 1:1 ratio into either the Edaravone Dexborneol Sublingual Tablets group or the placebo group, with a 24-week treatment period followed by a 28-week follow-up. The primary endpoint is a hierarchical composite endpoint at week 24, including all-cause mortality, modified Rankin Scale (mRS) score ≥2, recurrent stroke, changes in MoCA score, and changes in VaDAS-Cog score. Secondary endpoints include additional functional and cognitive assessments at 24 and 52 weeks, as well as MRI markers of white matter hyperintensities, new infarctions, microbleeds, and brain atrophy. Safety assessments will include adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs). The study aims to determine whether Edaravone Dexborneol Sublingual Tablets improve functional outcomes and cognitive performance in patients with small vessel disease-related stroke.

Prevention of Stroke Recurrence and Disease Progression in Cerebral Small Vessel Disease With Cilostazol

This study is designed to evaluate whether cilostazol, an antiplatelet medication, is more effective and safer than aspirin or clopidogrel in preventing recurrent strokes and slowing disease progression in patients with cerebral small vessel disease (CSVD). Cerebral small vessel disease is a common cause of lacunar stroke, cognitive decline, and long-term disability. Currently, aspirin and clopidogrel are widely used to prevent recurrent ischemic events, but their effectiveness in CSVD remains uncertain. Cilostazol has shown potential benefits in improving cerebral blood flow, protecting blood vessel walls, and reducing the risk of bleeding compared with traditional antiplatelet drugs. In this randomized controlled trial, participants diagnosed with CSVD and recent lacunar stroke will be randomly assigned to receive cilostazol, aspirin, or clopidogrel. The main outcomes to be evaluated include the rate of recurrent ischemic stroke, progression of cognitive and functional impairment, MRI markers of CSVD (such as white matter hyperintensity, lacunes, microbleeds, and small infarcts), and safety outcomes including bleeding events. The investigators hypothesize that cilostazol will reduce the risk of recurrent stroke and slow disease progression more effectively than aspirin or clopidogrel, with a comparable or lower risk of bleeding. By comparing these three antiplatelet drugs in a rigorous, multicenter randomized controlled trial, this study will provide important clinical evidence to guide personalized treatment strategies for patients with CSVD. The results are expected to improve long-term outcomes, reduce disability, and enhance the quality of life for stroke survivors.

Biomarkers, Risk Assessment, Imaging, and Neurodegeneration in Cerebral Small Vessel Disease (BRAIN-CSVD)

The BRAIN-CSVD study is a single-center prospective cohort study focusing on cerebral small vessel disease (CSVD).Patients enrolled in this research will undergo assessments for vascular risk factors, cognitive and other neurological functions, neuroimaging, and biomarkers. The study aims to explore imaging and biomarker predictors of CSVD progression, and the pathophysiological mechanisms of CSVD.

PUFFINS Brain Health Study

Small vessel disease (SVD) is a major cause of stroke and contributor to dementia cases. As work continues to develop new treatments to address the impact of SVD, new imaging techniques are needed to identify and track the progression of brain changes that occur with SVD. Magnetic Resonance Imaging (MRI) is the gold standard to diagnose poor brain health due to small vessel disease. However, current MRI systems are expensive and complex to operate, and so access is limited. Low-field MRI technology, operating at magnetic field strengths many times lower than conventional MRI, can make brain imaging much more cost-effective and accessible. However, further work is needed to develop low-field MRI towards clinically feasible assessments of brain health. The University of Aberdeen hosts a unique network of researchers and imaging technologies that is now making it possible to test and develop different low-field MRI approaches towards solving key healthcare challenges. The aim of this study is to evaluate the potential of two distinct approaches, field-cycling imaging (FCI) and ultra-low field MRI (ULF-MRI), to detect brain changes linked with small vessel disease. Automated methods will be developed to analyse images and extract measurements that detect and track progression of disease severity.

Correlation Between Deep Medullary Veins and Cognitive Dysfunction in Cerebral Small Vessel Disease

This study aims to obtain the characteristics of cognitive impairment and imaging characteristics of patients with Cerebral small vessel disease (CSVD) through comprehensive and standardized neuropsychological assessment and multimodal imaging examination. The focus is to obtain the characteristics of cognitive impairment and imaging characteristics of patients with CSVD through 3.0T MRI SWI sequence. deep medullary veins (DMVs) were measured. To compare the demographic data, hematological indexes, imaging scores and the number of DMVs between CSVD groups with and without cognitive impairment, and to explore the correlation between deep medullary veins and cognitive dysfunction in cerebral small vessel disease.

Intelligent Analysis and Clinical Validation of Cerebral Small Vessel Disease on Magnetic Resonance Imaging：A Multi-center Study

Cerebral small vessel disease (CSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of CSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) may represent as a sensitive and robust tool to detect early changes in brain subtle structures and functions. The study is to investigate the comprehensive evaluation by using AI in early diagnosis and management of CSVD.

Targeting 18kDa Translocator Protein (TSPO) to Improve Brain Endothelial Cell Function in Cerebral Small Vessel Disease

In healthy people, blood flow to particular areas in the brain increases when the area becomes more active. This ensures that the brain gets enough blood at the right place and time. In people with cerebral small vessel disease (cSVD), this process is disrupted, and the increased blood flow in response to activity is decreased or absent. Damage to the endothelial cells, that form the inner lining of blood vessels, is a key pathological process in cSVD. The aim of this study is to find out whether endothelial cell function and blood flow in cSVD can be improved by altering the function of a protein called TSPO. We will do this by using a drug called XBD173, which binds to TSPO. This is a double-blind, randomised, crossover study. cSVD patients will be recruited from memory clinics at Imperial College Healthcare NHS Trust. Participants will be invited to the clinical research facility (CRF) at Hammersmith Hospital and randomised to receive XBD173 or matched placebo, twice daily, for 4 weeks. After a 6-week washout, they will be switched to receive the other intervention. The study visits will involve MRI scans and blood tests to assess endothelial cell function. Healthy volunteers will also be recruited for image optimisation and control data. They will attend for a single MRI scan and not receive XBD173.