Hydrocephalus

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.

This research aims to evaluate the effectiveness and safety of treatment guided by intracranial pressure (ICP) monitoring to improve outcomes for patients with aneurysmal subarachnoid hemorrhage (aSAH). Aneurysmal SAH is a severe brain hemorrhage caused by ruptured intracranial aneurysms, which leads to increased ICP and serious neurological damage. Given the high rate of elevated ICP in these patients, the study addresses a critical need for evidence on using ICP monitoring in managing aSAH. Participants will be randomly assigned to one of two groups. In the experimental group, after surgical treatment of the aneurysm, a ventricular ICP monitoring probe is implanted to guide postoperative ICP management based on measurable ICP values. The control group receives standard aSAH treatment without ICP monitoring, relying instead on clinical signs and CT imaging to assess ICP. Both groups receive similar other treatments as appropriate. During the study, participants will be followed to assess neurological outcomes, including the rate of good neurological functional prognosis at 90 days as the primary measure. Additional outcomes include prognosis at 30 and 180 days, mortality, incidence of hydrocephalus requiring shunt, delayed cerebral ischemia, and epilepsy. Safety and effectiveness will be monitored over time, with assessments conducted through clinical evaluations and imaging. The study is planned to continue until late 2026.

This research aims to evaluate a wireless thermal anisotropy measurement device designed to non-invasively assess cerebrospinal fluid (CSF) shunt flow in people with hydrocephalus who experience chronic headaches. The study focuses on patients with existing ventriculoperitoneal (VP) shunts and frequent headache episodes, exploring the relationship between device measurements and headache occurrences. The study does not involve masking or placebo controls, and it is sponsored by Rhaeos, Inc. Participants will use a wearable device at home to measure CSF shunt flow across multiple sessions during periods with and without headaches. The device is designed to be applied over the shunt region where the skin is intact and the shunt is palpable. This study period lasts 30 days, during which participants will perform regular measurements remotely and attend in-person follow-ups as needed. Throughout the study, participants will record headache symptoms and device measurement data, which researchers will correlate to understand flow patterns. The main outcome is the correlation between device flow measurements and subject-reported headaches over 30 days. The study involves ongoing communication and symptom documentation in English, with safety and adherence monitored remotely and in-person during the measurement period. Participation lasts for the 30-day measurement and follow-up timeframe.

Researchers are evaluating the ability of the ShuntCheck test to detect flow or no flow in ventriculoperitoneal shunts among patients with asymptomatic normal pressure hydrocephalus. This observational study aims to determine the test's accuracy in identifying shunt function without symptoms, providing important information for routine care. Participants will undergo the ShuntCheck diagnostic test, which uses an FDA-cleared device that analyzes shunt flow through transcutaneous thermal convection. The study involves a single testing approach, with some assessments measuring the test performed twice to evaluate specificity and negative predictive value. During the study, participants will be monitored through the ShuntCheck test and routine clinical visits. Researchers will measure the specificity and negative predictive value of the test at 15 minutes and also assess these outcomes when the test is performed twice at 60 minutes. The study is sponsored by the University of South Florida and continues until November 2026.

Researchers are conducting a multi-center, retrospective study to continuously evaluate the safety of the Bactiseal catheter, an antibiotic-impregnated device used in patients with hydrocephalus. The study focuses on monitoring adverse events, including infections, that occur within two years after catheter implantation. It aims to collect data from medical records on the general and intraoperative conditions of patients and the catheter's performance. The study involves hydrocephalus patients who have had the Bactiseal catheter implanted to shunt cerebrospinal fluid. This single-arm study will retrospectively enroll 200 subjects who received the catheter between January 1, 2019, and June 30, 2022. Data collected includes adverse events, bacterial cultures, and drug resistance tests if infections occurred. Participants' medical information will be reviewed for up to two years following catheter implantation. Researchers will assess safety outcomes and infections related to the catheter. Information on previous surgeries, catheter details, and postoperative complications will be gathered to better understand the device's safety. The study does not involve additional interventions or visits, as it is based on existing medical records.

Researchers are investigating the biology and natural history of brain aging, focusing on cognitive aging and diseases like dementia and Alzheimer's, in adults aged 55 to 80. This population-based study aims to understand brain aging through a holistic view of environmental exposures, including nutrition, using advanced biological data methods. The study is conducted in Bordeaux and involves a representative sample of 2000 participants, emphasizing prevention and early detection of cognitive disorders. Participants will complete general health and nutrition questionnaires, undergo a computerized cognitive assessment, and provide various biological samples such as blood, urine, stool, saliva, hair, nails, and nasal swabs to create a biobank. MRI scans will be offered to volunteers aged 55 to 70. Those showing signs of cognitive or Parkinson's disorders may have additional neurological evaluations. A follow-up phase begins about three years after the initial visit, including repeated questionnaires, cognitive tests, and sample collections. Throughout the study, participants will undergo assessments of cognitive performance, nutrition, lifestyle, and immune function. Biological samples will be analyzed for metabolites and genetic data. Physical measurements and health screenings are performed during home visits. Researchers will track the availability of biobank samples and completed surveys as primary outcomes. The study includes multiple visits over several years to monitor brain health, cognitive changes, and related factors in older adults.

Hydrocephalus is a condition affecting up to 2 out of every 500 births and can cause long-term disability in many affected infants. This research aims to evaluate the safety and feasibility of using brain contrast-enhanced ultrasound (CEUS) in neonates and infants who have diagnosed or suspected hydrocephalus. Current standard care involves invasive shunts to relieve pressure, but better imaging tools are needed to assess brain health more accurately in this population. The study uses Lumason, a contrast agent injected through an existing intravenous line at a dose of up to 0.03 mg/kg, repeated twice per scan to improve image quality. The CEUS scans will capture dynamic brain blood flow and static images for analysis. The study allows up to two CEUS exams per participant within 1 to 2 weeks, each lasting about 1 hour and 30 minutes including the scan and monitoring. Participants will be monitored for safety for 60 minutes after each contrast agent administration. Imaging data will be analyzed both qualitatively by blinded radiologists and quantitatively using advanced post-processing techniques. The study will measure the feasibility and safety of CEUS scans and explore how ultrasound parameters relate to intracranial pressure and brain ischemia markers over the course of the study.

Researchers are studying idiopathic normal pressure hydrocephalus (iNPH) and related disorders to understand their clinical characteristics and natural progression. This prospective single-center study aims to identify digital, imaging, and molecular biomarkers that can help with diagnosis and therapy development. It also explores the causes and molecular mechanisms of these conditions to better understand their effects and outcomes. Participants are divided into groups including those diagnosed with hydrocephalus and a normal group. The study involves advanced diagnostic tests such as high throughput sequencing, whole genome and exome sequencing, transcriptomics, proteomics, metabolomics, and imaging techniques like DTIALPS. These tests are conducted to gather comprehensive data on the disease and its biomarkers. During study visits, patients undergo standardized clinical examinations and complete clinical rating scales. Biosamples such as blood, urine, cerebrospinal fluid, and muscle biopsies may be collected optionally. Additional assessments like neurophysiological exams, patient-reported outcomes, and imaging are also performed. Researchers measure changes from baseline in DTIALPS imaging and various clinical scales six months after ventriculoperitoneal shunt surgery. The study includes monitoring cognitive function, gait, and molecular patterns, with participation lasting through these assessments and follow-ups.