Active clinical trials for "Hydrocephalus"

Normal pressure hydrocephalus (NPH) consists of a triad of gait disturbance, cognitive deterioration, and urinary incontinence and is characterized by enlarged cerebral ventricles. Current treatment recommendations are based on surgical diversion of Cerebrospinal fluid (CSF), by a ventriculoperitoneal shunt. When patients are appropriately selected, shunting for NPH has a sustained effect in one-half to two-thirds of patients with a reasonable complication rate. However, evidence regarding the efficacy of shunt surgery consists largely of observational studies with relatively short-term follow-up. With regards to the adverse effects of shunting, even though decreased substantially in recent years, shunt complications are still common. Recent studies report ten to twenty-two percent of serious adverse effects following shunt surgery, mainly subdural hematoma (SDH) requiring surgery, infection, and cerebral infarction or hemorrhage. Most complication occur in the first year after the procedure. Many others suffer from adverse events that considered non-serious, such as postural headache and asymptomatic SDH. Since shunt complications are common and potentially severe, there is a need for a better way to identify those patients that will likely benefit from shunting, and find alternative treatments for those unwilling or unable to withstand surgery. Acetazolamide has been shown to reduce the production of CSF in clinical cases of raised intracranial pressure. It is considered the drug of choice for the treatment of idiopathic intracranial hypertension (pseudotumor cerebri). Intuitively, acetazolamide can be effective for the treatment of NPH by reducing the volume of CSF in the brain, and serve as a medical alternative to shunting. Few case reports and small series demonstrated improvement in MRI abnormalities in NPH-patients after administrating the medication. This open-label study will examine the feasibility and effectiveness of acetazolamide in NPH-diagnosed patients who are shunt-candidates. Patients will be treated from time of diagnosis, and gait and cognition will be evaluated after 2-6 weeks. This trial would possibly pave the way to a larger randomized placebo-controlled trials, and perhaps offer a medical alternative to surgery for elderly patients and for patients for which operation is contraindicated.

The purpose of the study is to compare the survival time (time to first shunt failure) of ventriculoperitoneal (VP) shunts inserted through an anterior entry site with those inserted through a posterior entry site in children. Shunt entry site is the location on the head that the shunt catheter enters the brain on its path to the fluid-filled spaces in the brain, the ventricles. Entry sites can be anterior or posterior.

The study will collect prospective cohort data of individuals that are undergoing routine clinical care for suspected idiopathic Normal Pressure Hydrocephalus (NPH). The administration of the Conner's Continual Performance Test - version 3 (CPT-3), an automated 14-minute computerized measure of reaction-time and sustained attention, will be added to the current neurocognitive screen being used (i.e., the Montreal Cognitive Assessment, MoCA) along with gait assessment. Patients will undergo pre-tap testing on the morning of their large volume Lumbar Puncture (CSF-TT). These patients will receive post-tap CPT-3 and MoCA testing one-to-three hours post-tap, and again at 2-3 days post-CSF-TT, during the follow-up appointment in clinic. The standard NPH quantitative assessment methods of MoCA and gait evaluation will continue to be collected. For those patients that ultimately undergo ventricular shunt placement, the CPT-3 will be administered at their post-operative follow-up appointment (~3 months post-operation). The results of CPT-3 will not factor into consideration for shunt candidacy.

Background: Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment of obstructive hydrocephalus in children and adults. Perforation of the third ventricle floor which is part of the hypothalamic-pituitary neuronal network is the key of this surgical procedure. Purpose: There are no prospective data available about the endocrine effects after ETV in children and adults. The principal aim of this prospective study is to evaluate the variability of hypothalamic-pituitary hormones and clinical effects in children and adults after ETV in order to plan a multicentric study.

Background: Despite the widespread use of external ventricular drainage, revision rates and associated complications are reported between 10-40%. Current available image-guided techniques using stereotaxis, endoscopy or ultrasound for catheter placements remain time-consuming techniques. Recently, a phone-assisted guide with high precision has been described. The development of an easy-to-use, portable, image-guided system could reduce the need for multiple passes and improve the rate of accurate catheter placement. This study aim to compare prospectively in a randomized controlled manner the accuracy of the freehand pass technique versus an an easy-to-use, portable mini-tablet-assisted guide for ventriculostomy catheter placement. Methods/Design: This is a single center, prospective, randomized, trial with blinded endpoint (ventricle catheter tip location) assessment. Adult patients with the indication for ventriculostomy, as proven by computed tomography (CT), will be randomly assigned to the treatment group or the control group. In patients of the treatment group, ventriculostomy will be performed using a mini-tablet-guided assistance based on preoperative CT imaging. Patients in the control group will receive standard free-hand ventriculostomy using anatomical landmarks. The catheter may be placed for external drainage or internal (ventriculoperitoneal) shunting in both groups. The primary outcome measure is rate of correct placements of the ventricular catheter, defined as a score of 1 to 3 on grading system for catheter tip location on postoperative CT scan. Primary outcome will be determined by one of the authors (NS) blinded for treatment allocation. We aim to include 320 patients in 3 years. Secondary Outcome Measures include 1) Frequency of placements required, 2) Frequency of completed placements within the ventricle of the perforated part of the tip of the catheter, 3) Frequency of very early and early shunt failures (revision of the ventricular drainage within 24 hours / within three weeks, 4) Frequency and Percentage of complications (procedure-related and nonsurgical) within three weeks, 5) Length of the trajectories from the dura level to the foramen of Monroe, the angle in the coronal plane towards midline (a) and towards the target (b) at the respective entry point, 6) ventricle size (the frontal occipital horn ratio (FOHR) and the width of the lateral ventricle in the coronal plane between the medial wall of the corpus callosum and the septum), 7) Differences (angles, distance of catheter tip from target) on the tablet-guided planned and postoperative trajectory on control computer tomography within 48 hrs (CT). Discussion: Here, we present the study design of a single center prospective randomized controlled trial to investigate whether tablet-guided application ventriculostomy is superior to the standard free hand technique. The strengths of this study are: 1. the prospective, randomized interventional character testing a new easy-to handle guided versus free-hand ventricular catheter placement, and 2. the power calculation is based on catheter accuracy using an available grading system for catheter tip location and calculated with use of recent study results of our own population, supported by data from prominent studies.

The goal of the study is to verify theoretical benefit of ventriculoperitoneal shunting with MIETHKE M.blue® valve in patients with iNPH. The study is designed to assess walking and balance, urinary function, cognitive performance and quality of life before and after shunting and compare the results between the patients with MIETHKE M.blue® and MIETHKE proGAV 2.0® (with SA 2.0®) valves.

The ASK CHILDREN study is intended to aid in future development of various neurologic devices (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information obtained to identify more efficient strategies in the evaluation and review of neuroprostheses regulated by the Agency.

The purpose of this study is to test and compare the efficacy of Endoscopic Third Ventriculostomy with shunting of Cerebrospinal fluid (CSF)for treatment for patients of Normal pressure Hydrocephalus.

A collection of biological samples (cerebrospinal fluid [CSF] and blood) from patients under 6 years of age who are diagnosed with intraventricular hemorrhage or spina bifida.

The research is designed to study the prognostic factors of ventriculoperitoneal (VP) shunt for iNPH by multi-omics research