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Cerebral Small Vessel Diseases clinical trials

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NCT ID: NCT06416371 Not yet recruiting - Vascular Dementia Clinical Trials

Retinal Vessel Leakage in Cerebral Small Vessel Disease

Start date: September 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about leakage from retinal vessels in cerebral small vessel disease. The main questions it aims to answer are: - Does retinal vessel leakage occur in cerebral small vessel disease? - If it does, is the severity of retinal vessel leakage similar to the severity of cerebral small vessel disease generally? Participants will be tested using fluorescein angiography. This involves an intravenous injection of fluorescent dye, and is a very sensitive way to find leakage from retinal blood vessels. Participants will have already had brain scans and other examinations and tests to measure the severity of their cerebral small vessel disease. Our new retinal images will complement the information from these previous tests.

NCT ID: NCT06380465 Not yet recruiting - Clinical trials for Cerebral Small Vessel Diseases

The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease

Start date: April 22, 2024
Phase: N/A
Study type: Interventional

Cerebral small vessel disease (CSVD) is a major cause of disability, cognitive impairment, and functional loss in the elderly. CSVD occurs due to damage to arterioles, capillaries, and venules in the brain parenchyma, and can cause clinical and neuroimaging symptoms. CSVD also accounts for up to 25% of all ischemic stroke cases, and making it the second leading cause of death in the world after ischemic heart disease. Purple sweet potatoes, scientifically known as Ipomoea batatas (L.) Lam., contains of high anthocyanin specifically peonidin and cyanidin that has antioxidant, anti-inflammatory, and potentially phytoestrogenic activity. These anthocyanins have been linked to a reduced risk of obesity, diabetes, and high cholesterol. They also show potential in improving endothelial function, thereby enhancing blood vessel vasomotor function and potentially reducing the risk of cardiovascular diseases. Anthocyanins and their metabolites can cross the blood-brain barrier and affect signaling pathways, gene expression, and protein function at the molecular level. In addition to their ability to enhance vascular flow, anthocyanins can also help mitigate the risk factors associated with CSVD by counteracting oxidative stress in the body. These findings exploring the potential benefits of anthocyanins for individuals with CSVD by giving purple sweet potatoes extract comparing with placebo. The outcomes that will be assessed are vasomotor reactivity measured by Breath Holding Index in Transcranial Doppler, Nitric Oxide, L-Arginine and Adiponectin levels in blood, Cognitive Test and Gait.

NCT ID: NCT06328842 Not yet recruiting - Clinical trials for Cerebral Small Vessel Diseases

Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients

Start date: March 2024
Phase: N/A
Study type: Interventional

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.

NCT ID: NCT06319495 Not yet recruiting - Clinical trials for Cerebral Small Vessel Diseases

Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease

Start date: March 2024
Phase: N/A
Study type: Interventional

This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

NCT ID: NCT06301711 Not yet recruiting - Clinical trials for Cerebral Small Vessel Diseases

Investigation of Potential Mechanisms in Stellate Ganglion Block in Individuals With Cerebral Small Vessel Disease

Start date: March 2024
Phase: N/A
Study type: Interventional

This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

NCT ID: NCT06077305 Not yet recruiting - Ischemic Stroke Clinical Trials

A Registry Study of Microcirculation Disorder After Cerebral Small Vessel Disease and Ischemic Stroke

MODEST
Start date: October 30, 2023
Phase:
Study type: Observational

This study aims to construct a registry platform for microcirculatory disorders in a large sample of Chinese patients with cerebral small vessel disease and ischemic stroke; To explore the role of microcirculatory disorders in different types of cerebral small vessel disease and iachemic stroke, as well as their pathogenesis, severity, and prognosis; And to research on the drug treatment of microcirculatory disorders for cerebral small vessel disease and stroke in the real world.

NCT ID: NCT06061692 Not yet recruiting - Clinical trials for Cerebral Small Vessel Diseases

Tongxinluo Capsule in the Treatment of Cerebral Small Vessel Disease-A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study(TOPS-CSVD)

Start date: October 2023
Phase: Phase 4
Study type: Interventional

Cerebral small vessel disease is a series of clinical, imaging and pathological syndromes caused by various etiologies affecting the arteries, capillaries, venules in the brain. The common causes of cerebral small vessel disease include arteriolosclerosis, cerebral amyloid angiopathy, hereditary cerebral small vessel disease, inflammation-and immune-mediated small vessel disease, venous collagen disease and other small vessel diseases. Of these, age-and hypertension-related cerebral small vessel disease and amyloidosis cerebral small vessel disease are the most common types. The pathophysiological mechanism and clinical manifestations of cerebral small vessel disease are complex. One-fifth of ischemic strokes and the vast majority of nontraumatic parenchymal hemorrhages are due to cerebral small vessel disease. In addition to stroke, patients with cerebral small vessel disease are more often characterized by chronic progressive neurological impairment, which is an important cause of cognitive decline and functional disability in the elderly, and has become one of the important public health problems affecting the quality of life of the elderly. Focusing on cognitive impairment-related diseases, a large number of clinical studies have shown that Tongxinluo capsule has a dual neurovascular protective effect, which can increase the Mini-Mental State Examination (MMSE) score and activities of daily living (ADL) score of patients with lacunar cerebral infarction combined with vascular cognitive impairment, reduce fibrinogen (FIB) concentration, improve whole blood viscosity, improve blood viscosity and FIB level, improve activities of daily living and accelerate intellectual recovery in patients with VD; It can also reduce the levels of ET-1 and homocysteine in AD patients, reduce the whole blood viscosity and thus improve the microcirculation in the elderly, increase cerebral blood flow, increase the scores of MMSE and ADL, improve the intelligence of patients, improve memory disorders and language disorders. Meta-analysis of 3458 patients in 40 published clinical literatures of Tongxinluo capsule both domestically and internationally confirmed that Tongxinluo capsule had the effect of promoting the recovery of neurological function, and was safe without adverse reactions. This project is a randomized, double-blind, placebo-controlled multicenter clinical study to investigate the clinical efficacy and safety of Tongxinluo capsule in the treatment of cerebral small vessel disease. A total of 1052 subjects who met the subject screening criteria are planned to be enrolled, with 526 patients in the test group and 526 patients in the placebo group. The study is conducted using a central randomization method. For the patients who met the inclusion criteria after examination, they are logged into the Interactive Web Response System by their site, entered the relevant information, and randomized and assigned drugs automatically by the central server according to the ratio of 1:1. Once enrolled, all patients receive the study drug (Tongxinluo or placebo) at 4 capsules/tid for up to 12 months. The study is planned to be conducted at approximately 50 centers across the country using central randomized competing enrollment.

NCT ID: NCT05982470 Not yet recruiting - Clinical trials for Mild Cognitive Impairment

Effect of Menopause Hormone Therapy In Postmenopausal Women With CSVD And MCI

MIRACLE
Start date: August 18, 2023
Phase: Phase 2
Study type: Interventional

The objective of this clinical trial is to explore the efficacy of menopausal hormone therapy in early menopausal women with CSVD and MCI. The main questions it aims to answer are: - The efficacy of menopausal hormone mainly estrogen therapy for early menopausal women with CSVD and MCI - The role of MHT in delaying the progression of cognitive function, CSVD imaging features, and other clinical symptoms and the potential pathophysiological mechanisms. Participants will be divided randomly into two groups taking MHT drugs and placebo respectively and followed up for 12 months to collect relevant clinical data.

NCT ID: NCT05967728 Not yet recruiting - Ischemic Stroke Clinical Trials

Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care

TRIC-SVD
Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

This early phase trial will address the following key objectives: 1. Completion of initial safety and tolerability testing of our viable prototype for remote ischemic conditioning (RIC) with patients with (a) CSVD and (b) acute ischemic stroke. 2. Usability testing of the prototype with patients and healthcare professionals, with further optimization. Approximately 24 patients with CSVD will be recruited to use the RIC device daily for 60 days and provide feedback. They will be randomized in a 1:1 ratio to either true RIC therapy or sham control for the first 30 days, after which the sham group will cross over to receive true RIC for the remaining 30 days. Feasibility testing will be done in the mobile stroke unit on up to 10 patients with acute ischemic stroke. An additional 10 stroke physicians and paramedics will conduct device usability testing and provide feedback.

NCT ID: NCT05793424 Not yet recruiting - Clinical trials for Cerebral Small Vessel Diseases

Establishment of a CSF Bank for the Development of Biomarkers of Smooth Muscle Cell (SMC) Damage in Monogenic Cerebral Small Vessel Disease

CSF-cSVD
Start date: March 2023
Phase:
Study type: Observational

The main objective of this research is to obtain biological markers of smooth muscle cells dysfunction or degeneration in cerebral small vessel diseases. The aim of this research is therefore to build up a biocollection of CSF and blood samples from 1) patients with CADASIL disease (the most common form of cSVD) responsible for an accumulation of the NOTCH3 protein in the microvessel wall, 2) patients with other forms of monogenic cSVD (rarer) which are not responsible for an accumulation of this protein despite the damage to the smooth muscle cells of the vessel wall and 3) control patients without cSVD, collected in the context of care. This bio-collection will allow the identification and assay of markers testifying to the damage of the smooth muscle cells (SMC) in different types of cSVD of hereditary origin, the first of which will be the soluble NOTCH3 protein.