Cerebrovascular Disease

Researchers are studying patients who have had an acute ischemic stroke affecting the basal ganglia and were treated with mechanical thrombectomy. The study aims to understand how often and in what ways cognitive, motor, and sleep problems occur after this treatment. The main focus is on defining these possible dysfunctions in the short and long term after stroke treatment. The study involves patients who have undergone mechanical thrombectomy for stroke in the proximal middle cerebral artery. Participants will be evaluated using tests for cognitive function, movement abilities, and sleep disorders. Specifically, sleep will be studied through polysomnographic examinations. Assessments occur in the acute phase soon after treatment and continue through long-term follow-up. Participants will undergo testing for cognitive, motor, and sleep function within 72 hours after their stroke treatment and at later points to monitor changes over time. The primary outcome is the presence of post-stroke cognitive dysfunction measured shortly after treatment. The research team will closely observe clinical outcomes related to movement and sleep as well. The study is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and involves adult participants starting from age 18.

Carotid artery plaque rupture is a leading cause of ischemic stroke, and early, accurate assessment of plaque vulnerability can help prevent these strokes. Researchers are studying the use of 18F FDG and 68Ga-FAPI PET/MR imaging to investigate features of vulnerable carotid plaques, such as active fibrosis and inflammation, which may better identify unstable plaques compared to standard MRI alone. This observational study aims to clarify imaging characteristics linked to plaque instability in patients with carotid artery plaques. Participants will undergo 18F FDG and 68Ga-FAPI PET/MR scans to assess metabolic and structural plaque features. Treatments such as medication, carotid stenting, or carotid endarterectomy will follow clinical guidelines but are not assigned by the study. The study focuses on evaluating plaque vulnerability through advanced imaging rather than testing specific treatments. During the study, participants will be monitored for stroke and cerebral hemorrhage at 1, 6, and 12 months after their PET/MR scan. Researchers will also assess the openness of the carotid artery (lumen patency rate) and analyze imaging results at these same time points. This approach aims to track plaque changes and clinical outcomes over one year to better understand plaque behavior and risk.

Aneurysmal subarachnoid hemorrhage (SAH) is a severe type of stroke that can cause early brain injury, vasospasm, and delayed cerebral ischemia. These complications are usually diagnosed using brain imaging techniques like CT scans, MRI, and arteriography, which require moving critically ill patients within the hospital, posing risks. This research aims to evaluate a new non-invasive bedside device using 3D enhanced ultrasonography to detect the main arteries in the brain's anterior circulation, potentially improving diagnosis without the need for transportation. Participants with aneurysmal SAH affecting the anterior circulation will undergo three bilateral transcranial enhanced ultrasonography scans using a device with microbubble contrast agent (Sonovue), performed at three key risk periods: days 0-2, 4-10, and 11-14. This pilot study will not alter standard care but will assess the quality of the imaging signal and compare findings with clinical outcomes. The study plans to include 15 patients at a single center. During the study, patients will receive the enhanced ultrasonography scans at bedside without moving to other hospital locations. Researchers will measure the presence and quality of the time-intensity curve from the contrast agent as the primary outcome. Secondary outcomes include comparing ultrasound data to clinical signs of brain injury and vasospasm, detecting principal arteries, and evaluating measurement consistency. The study will run until March 2025 and aims to assess feasibility and potential clinical benefits.

Atherosclerotic plaques, which are fatty build-ups in arteries, can develop silently and may rupture, leading to serious cardiovascular events like heart attacks or strokes. Despite treatments and controlling risks such as diabetes and high blood pressure, some people still develop dangerous forms of the disease. Researchers have found that plaques with thin caps, soft centers, or tiny new blood vessels are more likely to rupture, so new imaging methods are being developed to detect these vulnerable plaques earlier. This study evaluates a new 3D ultrasound probe and machine that can capture many more images than standard probes to visualize the entire plaque and its tiny blood vessels more accurately. Patients will receive an infusion of a microbubble contrast agent called SonoVue to enhance imaging. Initial 2D ultrasound images will confirm plaque presence, followed by 3D imaging using a specialized row-column array probe manipulated by a clinician. The 3D scan takes about 2 to 5 minutes and captures multiple images to assess plaque neovascularization. Participants will undergo ultrasound scans of their carotid arteries after receiving the contrast agent via an infusion. Researchers will analyze these images offline to detect new blood vessels within plaques. The main measurement is the detection of carotid plaque neovascularization at baseline. The study begins with consenting patients who have carotid plaques confirmed by previous CEUS scans. Participation involves imaging procedures and consent, with the study lasting as long as these assessments are completed.

Researchers are evaluating the use of [18F]AlF-NOTA-octreotide PET/MRI to study inflammation in carotid artery plaques in patients who recently had a stroke or transient ischemic attack (TIA) in the carotid artery area. This study aims to see if the tracer uptake in affected and unaffected carotid arteries can predict future cerebrovascular events such as recurrent TIA, stroke, or other vascular problems. The trial is conducted as a Phase 2 study at University Hospitals Leuven and focuses on patients with at least 30% stenosis in the carotid artery. Participants receive a single intravenous injection of the radioactive tracer [18F]AlF-OC, dosed at 4 MBq/kg, followed by a saline flush. The study has two parts: in the first, five patients undergo PET/MRI scans at 60, 120, and 180 minutes after injection to refine the imaging protocol. In the second part, nineteen patients receive PET/MRI at the optimal time point identified earlier. Both the symptomatic (culprit) and non-symptomatic carotid arteries are scanned. Participants will have a screening and baseline assessment, followed by the PET/MRI imaging visit. They will be contacted by telephone for follow-up interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA. Researchers will measure the standardized uptake values (SUV) of the tracer in the carotid arteries as the primary outcome. Secondary outcomes include the prediction of recurrent cerebrovascular events, major cardiovascular events, and overall mortality during the three-year follow-up period.

Researchers are evaluating the effect of involving caregivers in a rehabilitation approach called caregiver-assisted rehabilitation with strategy training (CAR-ST) to improve daily activity functions in adults who have had a stroke. The study aims to compare CAR-ST with strategy training alone and with an education program to see which approach leads to better improvements in activity performance and whether these improvements extend to other areas like participation and impairment. This is a single-blinded, three-arm randomized controlled trial conducted in multiple centers to assess the potential benefits of caregiver involvement in home-based post-stroke rehabilitation. Participants will be randomly assigned to one of three groups: CAR-ST, strategy training alone, or an education program. The CAR-ST and strategy training groups receive up to 10 therapist-guided sessions over a maximum of 6 weeks, with sessions once or twice weekly lasting about 60 minutes each. CAR-ST involves caregivers actively assisting and motivating participants during at-home practice, while the strategy training group does not include caregiver participation. The education group receives 10 matched sessions focused on stroke information delivered through face-to-face talks, video calls, or phone calls. During the study, participants will be assessed at four time points: before treatment, immediately after the intervention, and at 3- and 6-month follow-ups. Researchers will use various clinical tools to measure changes in activity performance, participation, quality of life, self-efficacy, motor function, cognition, and goal attainment. Qualitative interviews will also explore participant and caregiver experiences and satisfaction. The total involvement spans from baseline through six months after treatment, with continuous monitoring and data analysis to evaluate the interventions' impact.

Researchers are evaluating whether neflamapimod, a drug that inhibits the enzyme p38 alpha kinase, can improve physical disability and cognitive problems after moderate to severe acute ischaemic stroke. This is a phase 2, randomized, double-blind, placebo-controlled study focused on recovery following stroke in adults aged 45 and older. The study is sponsored by EIP Pharma Inc and aims to assess motor recovery and functional improvements over 12 weeks of treatment. Participants will be assigned to one of several groups receiving either neflamapimod or a placebo. The drug and placebo are given as capsules taken with food either three times daily or twice daily for 12 weeks. The study includes two cohorts with differing capsule dosing schedules. The treatment phase lasts for 12 weeks, during which the effects of neflamapimod on motor function and stroke recovery are evaluated. During the study, participants will undergo assessments including the Fugl-Meyer Assessment of Motor Recovery after Stroke, the Timed Up and Go Test, and the National Institutes of Health Stroke Scale to measure changes in motor skills and overall stroke severity. Additional measures include the Modified Rankin Scale and Barthel score to evaluate functional independence. The trial involves regular monitoring and evaluations from enrollment through the end of the 12-week treatment period.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are evaluating MT200605, a drug that acts like brain-derived neurotrophic factor (BDNF) by protecting brain nerve tissues and supporting energy production in the brain's striatum. This study focuses on patients who have had an acute ischemic stroke within 24 hours, aiming to see if MT200605 can help reduce brain injury and improve recovery. The trial is a Phase II exploratory study conducted at 32 centers in China, enrolling 360 patients. Participants will be randomly assigned to receive either a low, medium, or high dose of MT200605 or a placebo. All patients will also receive standard medical care. The study drug or placebo is given twice daily by intravenous infusion for 14 consecutive days. The trial uses a double-blind design, meaning neither participants nor researchers know which treatment is given. During the study, researchers will assess patients using the modified Rankin Scale (mRS) to measure disability three months after the stroke. They will also evaluate changes in the National Institutes of Health Stroke Scale (NIHSS) score two weeks after treatment. Safety, brain function, and recovery will be closely monitored throughout the trial, which starts in October 2025 and continues until June 2026.

Researchers are evaluating whether combining two non-invasive brain stimulation methods—muscle stimulation of the arm using functional electrical stimulation (FES) and neurostimulation through the tongue—can improve recovery after stroke. This study focuses on adults who have experienced a stroke and have upper extremity motor impairments, aiming to measure changes in motor function and brain plasticity using behavioral tests and functional MRI scans. Participants are divided into several groups including stroke patients with upper extremity impairments receiving EEG-guided brain-computer interface (BCI) training combined with muscle and tongue stimulation, stroke patients receiving traditional rehabilitation before starting BCI-FES-tongue therapy, stroke patients receiving standard FES therapy only, healthy controls, and people with stroke risk factors. The study involves training sessions with the EEG-BCI system, muscle and tongue stimulation, and the use of the recoveriX system, which provides real-time visual and tactile feedback paired with imagined hand movements. The intervention periods vary, with some groups receiving delayed therapy and others immediate BCI therapy. Participants will undergo multiple assessments including behavioral tests of upper extremity function, EEG recordings, and functional MRI scans at the start and after about four months of therapy. The researchers will monitor changes in arm function using the Action Research Arm Test and observe brain activity changes through EEG and fMRI. The study includes up to six BCI training sessions and regular evaluations over approximately 10 weeks, with some groups receiving additional follow-up MRI and behavioral testing. Safety screening excludes those with allergies to electrode materials or contraindications for MRI, and pregnant women are not eligible.