Formative Usability Assessment of Wireless Thermal Anisotropy Devices
HydrocephalusMeasurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
HydrocephalusHydrocephalus in Children5 morePost-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research...
Pediatric HydrocephalusThe Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic funding to conduct multi-institutional research (clinical trials and observational studies) on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received an NIH NINDS Challenge Grant to support the network infrastructure which allows for the conduct of this and other network studies. The HCRN consists of multiple Clinical Centers and the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all neurosurgical hydrocephalus events from the network Clinical Centers, and create a database to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two main purposes: 1) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in children, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and study design (i.e. preliminary power analyses, recruitment projections) for studies under development by the HCRN. This multi-institutional database will be maintained throughout the lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over time. The Core Data Project will be an invaluable resource to the HCRN and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of children with hydrocephalus cared for within the network.
AI Assisted Reader Evaluation in Acute Computed Tomography (CT) Head Interpretation
Intracranial HemorrhagesAcute Ischemic Stroke4 moreThis study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838). The purpose of the study is to assess the impact of an Artificial Intelligence (AI) tool called qER 2.0 EU on the performance of readers, including general radiologists, emergency medicine clinicians, and radiographers, in interpreting non-contrast CT head scans. The study aims to evaluate the changes in accuracy, review time, and diagnostic confidence when using the AI tool. It also seeks to provide evidence on the diagnostic performance of the AI tool and its potential to improve efficiency and patient care in the context of the National Health Service (NHS). The study will use a dataset of 150 CT head scans, including both control cases and abnormal cases with specific abnormalities. The results of this study will inform larger follow-up studies in real-life Emergency Department (ED) settings.
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure...
HydrocephalusNormal PressureThe purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.
Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of...
HydrocephalusIntracranial HypertensionPuncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is commonly performed in order to treat and/or measure pathologically elevated intracranial pressure.Therefore a safe and fast surgical procedure is needed. Currently the "landmark-based" placement of intraventricular catheters is the gold standard. However it is known that more than 60% of the catheters are not accurately placed in accordance with "landmark-based" procedures. When the catheter is not placed accurately multiple punctures may be required. In this study, the investigators aim to investigate prospectively whether ultrasound guidance leads to a lower number of incorrect catheter placements, and whether this guidance consequently decreases the number of punctures.
A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patients...
Parkinson DiseaseMultiple System Atrophy2 moreThis will be an observational study looking at clinical and biomarker characteristics in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Rapid Eye Movement Sleep Behavior Disorder (RBD), Normal Pressure Hydrocephalus and matched controls. Saliva, plasma, serum, urine, and cerebrospinal fluid (CSF) samples will be collected from participants.
Study of Choroid Plexus Cauterization in Patients With Hydrocephalus
HydrocephalusThe purpose of this study is to determine whether endoscopic choroid plexus coagulation is safe in adult patients with communicating hydrocephalus and risk factors for complications from the standard surgical treatment. It may also help determine whether the endoscopic choroid plexus coagulation is effective in treating your communicating hydrocephalus. The Investigators hope that this research will allow us to place fewer shunts in patients with conditions similar to yours, avoiding complications.
Using Cerebrospinal Fluid Dynamics to Optimize Treatment of Idiopathic Normal Pressure Hydrocephalus...
HydrocephalusNormal PressureThe purpose of the study is to determine if the so called pulsatility curve, which describes the relationship between intracranial pressure (ICP) and ICP pulsatility, can be used to predict outcome of treatment, in the form of shunt surgery, in idiopathic normal pressure hydrocephalus (INPH) and to guide the adjustment of shunt opening pressure after the surgery. The main hypotheses of the study are: The pulsatility curve may be the best auxiliary test to predict shunt surgery outcome in INPH patients. With a "fixed" shunt opening pressure, the preoperatively assessed potential pulse amplitude reduction (determined by analysis of the pulsatility curve) predicts postoperative improvement in gait velocity and cognitive functions. A postoperative pulsatility curve can be used to further optimize ICP pulsatility by guiding opening pressure adjustment. Shunt adjustment based on the pulsatility curve three months postoperatively will increase improvement, but not complications, compared to a shunt with "fixed" opening pressure. Based on these hypotheses, three specific aims for the study have been defined: To determine if improvement three month after surgery is associated with postoperative reduction in pulse amplitude. To determine if a pulsatility curve obtained preoperatively can predict improvement in gait velocity and cognitive functions in INPH patients three months after surgery. To compare outcome six months after surgery and complications rates between INPH patients with a "fixed" opening pressure versus those where the shunt has been adjusted based on the pulsatility curve, three months after the shunt insertion.
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via...
Intracranial HypertensionBrain Injuries3 moreInvasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head. HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.