Brain Aneurysm

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.

Researchers are working to create and use a comprehensive database focused on intracranial aneurysms (IA). This project collects and studies clinical history, imaging data, biological samples, and other information to understand factors linked to the formation and rupture of aneurysms. They aim to identify genetic, environmental, and anatomical markers, as well as evaluate outcomes from different treatment strategies and improve patient care protocols. Participants include patients with diagnosed aneurysms, both ruptured and unruptured, family members of affected individuals, and healthy volunteers. Data collected involves detailed clinical records, imaging scans like MRI angiography and CT angiography, and various biological samples such as blood, cerebrospinal fluid, saliva, and stool. Consent covers access to medical records, use of biological samples, and potential future research uses including genetic analyses. During the study, participants provide health and lifestyle information, imaging data, and biological samples. Researchers will monitor multiple long-term outcomes including disease progression, life expectancy, quality of life, neurological and cognitive status, and treatment effects over periods up to 20 years. Data confidentiality is maintained, and participants can withdraw at any time without affecting their medical care. The study aims to validate disease models and support advances in aneurysm management and research.

Researchers are investigating the effects of two different doses of bevifibatide citrate injection for patients who have had an acute ischemic stroke without large or medium-sized vessel blockage. This phase 2, single-center, randomized, double-blind trial aims to find a dose that improves neurological outcomes 90 days after stroke while minimizing the risk of symptomatic brain bleeding and serious side effects. The trial will provide important information to guide future larger studies on dosing. Participants receive bevifibatide citrate injection through an intravenous bolus of 220 mcg/kg over 1 to 2 minutes, followed by a continuous intravenous infusion for 24 hours. Two groups receive different maintenance infusion rates: one at 2.5 mcg/kg/min and the other at 2.0 mcg/kg/min. After the infusion and if imaging within 48 hours shows no significant brain bleeding, patients will take aspirin and clopidogrel tablets daily until day 90. Patients are also managed according to current stroke care guidelines, including possible use of low molecular weight heparin for blood clot prevention. During the study, participants will have neurological assessments using the modified Rankin Scale and National Institute of Health Stroke Scale at various time points up to 90 days. Brain scans will monitor for bleeding within 48 hours. Researchers will track adverse events, mortality, platelet aggregation inhibition, and quality of life. Follow-up lasts 90 days after treatment to evaluate both safety and neurological recovery. The total participation duration covers initial treatment and multiple assessments over this period.

Researchers are studying the development of neural flexibility, measured by MRI, as an indicator of cognitive flexibility in Chinese toddlers aged 32 to 42 months. The study also evaluates executive functions such as inhibition, shifting attention, emotional control, working memory, and planning using the Global Executive Composite score from a standardized rating scale. This research aims to better understand brain development and cognitive abilities during early childhood. Participants are divided into two groups based on their daily milk consumption: one group receives S-26 GOLD or ULTIMA GUM formula, while the other consumes cow's milk. Parents continue feeding their children these milk products throughout the study, and information about milk consumption is collected starting up to two months before and during the study period. The brain is examined using MRI, a safe and non-invasive imaging technology. During the study, toddlers undergo MRI scans and assessments of brain structure and function at the start and again at 42 months of age. Researchers also evaluate cognitive flexibility, behavior, curiosity, sleep quality, home environment, feeding practices, and fecal microbiota composition over time. Parents provide information through interviews, and the child's development and school readiness are monitored. The study runs from baseline through 42 months of age, with additional home environment data collected at 8 months after baseline.

Researchers are evaluating the CIPHER System in patients undergoing brain tumor removal surgery for newly diagnosed supratentorial glioma. This First-in-Human clinical investigation aims to assess the safety and basic performance of a novel, highly flexible, electrode-dense cortical probe designed for neurophysiological mapping and stimulation during brain tumor resection. The study focuses on how well the device functions and its handling characteristics during short-term use in surgery. Participants will have the CIPHER Probe placed on the surface of the brain during standard tumor removal surgery. Two groups are studied: one where only neural activity is recorded and another where both recording and electrical stimulation are performed using the probe. No stimulation is delivered in the recording-only group. The device is tested on the main tumor area and the surrounding tissue margin just before tumor removal. During the study, participants will be monitored through hospital visits during their recovery period, including follow-ups at two and six weeks after surgery. Researchers will collect data on any device or procedure-related adverse events, spontaneous neural activity, signal quality, and device deficiencies. The total study period includes enrollment through the six-week postoperative follow-up to evaluate safety and device performance.

Gliomas are aggressive tumors that originate from glial or stem cells, with patients typically surviving between 12 to 15 months. This research investigates whether a classic ketogenic diet (CKD), which restricts carbohydrate intake and increases fat consumption to induce ketosis, can help extend survival in patients with high-grade gliomas and brain metastases. The study compares outcomes to historical controls to evaluate the diet's potential therapeutic effect. Participants will follow the CKD for an initial period of 3 months, which is a high-fat, low-carbohydrate diet adjusted to each patient's energy needs by dietitians. This diet aims to reduce blood glucose levels and increase ketone bodies to stimulate biochemical changes. Patients and their families will receive training on meal planning and ketone/glucose monitoring, and dietitians will provide ongoing support and follow-up visits. Throughout the study, participants will regularly monitor their urine and blood ketone levels daily and maintain records. Researchers will assess overall survival up to 36 months, tumor size changes, time to progression, quality of life, and functional impairment using established scales and surveys. Follow-up evaluations will occur at baseline and various intervals up to 24 months. The study includes safety assessments and continues monitoring until death or the study endpoint.

Researchers are investigating the effects of a multidomain lifestyle intervention to slow cognitive decline and dementia risk in elderly residents aged 60 to 80 in Zhejiang Province, China. The study builds on findings from Finland, where a similar approach combining physical activity, nutrition, cognitive training, social activities, and vascular risk management showed promise in healthy older adults at risk of cognitive decline. This trial aims to explore how such an intervention may change brain structure and function as well as cognitive abilities in an Asian population. Participants are randomly assigned to either a structured multidomain intervention group or a self-guided control group. The intervention group receives tailored nutritional guidance, cognitive training, physical exercises, and vascular risk monitoring, all adapted to Chinese cultural norms. The control group receives regular health education campaigns and basic health monitoring every 6 to 12 months. This trial runs for two years with ongoing assessments to evaluate the impact of these lifestyle changes. During the study, participants undergo various evaluations including cognitive tests measuring global and domain-specific cognition, neuroimaging scans like MRI and fMRI, laboratory blood tests, and physical performance measures such as grip strength and gait speed. Questionnaires assess quality of life, depression, sleep quality, and daily activities. Researchers also monitor cardiovascular health, dementia onset, and falls. This comprehensive monitoring will help determine the intervention's effects on brain health and daily functioning over the 24-month period.

Researchers are evaluating the safety and performance of the Choydar Flow-Directed Mesh Stent in treating unruptured intracranial aneurysms, which are bulging blood vessels in the brain that have not ruptured. This observational study aims to gather real-world data on how well this stent works in patients with these aneurysms, focusing on treating wide-neck saccular or fusiform aneurysms in specific brain arteries. The study involves using the Choydar Flow-Directed Mesh Stent according to its official instructions in participants who have unruptured aneurysms in the internal carotid or vertebral arteries. Only this stent will be used for treatment, and no other interventions are part of the study. The stent is placed during a procedure guided by imaging techniques to treat the aneurysm. Participants will be monitored through follow-up visits over 12 months after the procedure. Researchers will assess outcomes such as the rate of complete and adequate aneurysm closure, technical success at the time of the procedure, need for additional treatments, functional status using a modified scale, and any major complications or vessel narrowing. The study tracks safety events during the procedure and throughout the year to understand long-term effects. Participants must be able to return for all follow-up visits as required.

Researchers are developing a new, comprehensive AI vision-language foundation model to improve diagnosis and interpretation of various brain diseases. This observational study aims to use multiple types of data including patient demographics, medical imaging like MRI, CT, and PET scans, histopathological and genomic data when available, plus other lab tests to create a detailed screening and diagnostic tool for brain diseases. The study also seeks to establish a diagnostic model that includes uncertainty quantification and automated report generation for a wide range of brain conditions. Additionally, the model will be validated using MRI scans from large populations. This study does not involve any interventions or treatments. Instead, it collects and analyzes a variety of clinical and imaging data from patients diagnosed with brain diseases such as brain tumors and neurodegenerative disorders, as well as from individuals without brain disease who have complete brain MRI scans and clinical data. Data quality is important, so cases with incomplete or poor-quality MRI scans are excluded from analysis. Participants will contribute their existing clinical case data and brain imaging results to support model development and validation. The main outcome measure is the performance of the AI model in diagnosing brain diseases during the perioperative period. Since this is an observational study, there are no active treatments or procedures for participants. The study is sponsored by Xiangya Hospital of Central South University and aims to advance brain disease diagnosis through large-scale data analysis and AI technology.

Researchers are evaluating the safety and effectiveness of a new device called the IRRAflow Active Fluid Exchange System compared to the standard External Ventricular Drain (EVD) in patients with brain bleeding and infections. This study focuses on conditions such as intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, and ventriculitis. The goal is to see if the IRRAflow device can better remove cerebrospinal fluid, blood, and harmful bacteria from specific brain spaces. Participants will be randomly assigned to receive either the IRRAflow device or the EVD device. Both devices are used to monitor and reduce intracranial pressure by draining excess fluid from the brain. The IRRAflow system includes an irrigation feature to help keep the drainage catheter clear by using programmed pulses of fluid, while the EVD device represents the current standard care method. After the procedure, participants will be followed for one month to compare outcomes between the two groups. During the study, participants will undergo various assessments including head CT scans to measure clearance of blood or bacterial mass, monitoring for catheter-related infections, tracking the length of stay in intensive care, and evaluating functional status at the start and 30 days after discharge. Researchers will also monitor rates of revision procedures, shunt dependency, and mortality during and after treatment. The study aims to provide detailed information about how these devices perform in managing intracranial bleeding and infections over a one-month period.