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Hydrocephalus, Normal Pressure clinical trials

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NCT ID: NCT04471740 Recruiting - Sleep Apnea Clinical Trials

Normal Pressure Hydrocephalus and Sleep Apnea

NPH/OSA
Start date: July 2, 2020
Phase: N/A
Study type: Interventional

Normal-pressure hydrocephalus is associated with increases in the intracranial pressure during the night sleep. Sleep apnea also increases the intracranial pressure during the apneic spells. When patients are operated the distal part of the shunt is inserted inside the abdominal cavity, which pressure also increases during the sleep apnea episodes. this is particularly important considering that the recumbent position used to sleep further increases the intraabdominal pressure and that impairs the CSF drainage through the shunt system. The purpose of this study is to analyze the intracranial and intraabdominal pressures during the sleep, particularly during the sleep apnea episodes to see which shunt should be used, to which cavity should be drained (peritoneum or heart) and if correcting the sleep apnea has some positive result on the hydrocephalus symptoms.

NCT ID: NCT04434053 Recruiting - Clinical trials for Normal Pressure Hydrocephalus

Adjustable Gravitational vs. Adjustable Differential Pressure Valves in iNPH

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04309487 Recruiting - Clinical trials for Hydrocephalus, Normal Pressure

Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus

Start date: January 24, 2020
Phase:
Study type: Observational

The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

NCT ID: NCT04011566 Recruiting - Clinical trials for Hydrocephalus, Normal Pressure

Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus

Start date: June 11, 2019
Phase:
Study type: Observational

The 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.

NCT ID: NCT03877107 Recruiting - Clinical trials for Normal Pressure Hydrocephalus

Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH

PLHPN
Start date: March 13, 2019
Phase: N/A
Study type: Interventional

Lower urinary tract dysfunction in normal pressure hydrocephalus has received little attention from the scientific community. Urinary symptoms in normal pressure hydrocephalus are mainly represented by overactive bladder, which is a significant burden for the concerned patients. A harmonization of neuro-urological practices in the pre-therapeutic evaluation of patients suffering from normal pressure hydrocephalus is necessary. The investigators conducted a bicentric prospective study aiming to evaluate the effect of depletive lumbar puncture on urinary symptoms in iNPH. The secondary objective was to evaluate, in the same participants previously diagnosed, the effect of cerebrospinal fluid shunt surgery on urinary symptoms.

NCT ID: NCT03779594 Recruiting - Clinical trials for Normal Pressure Hydrocephalus

Acetazolamide for Treating NPH in Shunt-candidates Patients

Start date: December 2018
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT03245138 Recruiting - Clinical trials for Normal Pressure Hydrocephalus

Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus

Start date: June 2016
Phase: N/A
Study type: Interventional

An endoscopic third ventriculostomy is considered to be successful in idiopathic normal pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled, multicenter study.

NCT ID: NCT03092804 Recruiting - Clinical trials for Normal Pressure Hydrocephalus

The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients

Start date: August 1, 2016
Phase: N/A
Study type: Observational

With the advent of the aging society, dementia becomes the focus of common people. As for the neurodegeneration dementia, no disease modifying treatments have been discovered. Idiopathic normal pressure hydrocephalus (iNPH) is considered as one of reversible dementia, which can be hint by the surgery. In addition, dementia of iNPH is the typical subcortical dementia. Therefore exploring the pathogenic mechanism is conducive to the early diagnosis and treatment. This research is to monitor the changing of iNPHGS, cognitive function, walking ability as well as brain construction imaging and neural network before and after ventriculo-peritoneal shunting in order to demonstrate the pathogenesis of triads. In the process, the supplementary test, for instance, CSF tap test, will be validated the predictive value.

NCT ID: NCT02495610 Recruiting - Clinical trials for Idiopathic Normal Pressure Hydrocephalus

Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With iNPH

iNPH
Start date: June 2015
Phase: N/A
Study type: Interventional

INPH is a chronic, progressive disease characterised by enlarged ventricles in the absence of elevated intracranial pressure. Patients often present with the Hakim triad comprising gait disturbance, dementia and urinary incontinence. Treatment consists of ventriculoperitoneal (VP) shunting reducing the cerebrospinal fluid (CSF) volume in the central nervous system (CNS); a generally safe and well tolerated procedure nevertheless invasive in nature and associated with surgical risk. The currently used diagnostic algorithms to predict surgery outcome by testing patients before and after a diagnostic spinal tap temporarily reducing the CSF volume in the CNS are of wide variability and limited validity. Developing measures to accurately diagnose and select patients for intervention is thus of great importance. The objective of this study is to define and validate a diagnostic algorithm for the selection of patients with symptoms compatible with iNPH for shunt surgery.

NCT ID: NCT01618500 Recruiting - Clinical trials for Normal Pressure Hydrocephalus

Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus

Start date: January 2012
Phase: N/A
Study type: Observational

A novel computerised neuropsychological test battery for normal pressure hydrocephalus (NPH) has been developed. The aim is to provide the clinician with a free of charge, standardized tool, assessing the cognitive decline or improvements in the cognitive domains specific for NPH. Results from the battery indicate good reliability and validity for the computerized tests Results from the computerised battery seems promising. However, ability for the battery to detect cognitive improvements after a shunt operation remains to be tested. Study objectives 1. Improvement after shunt. The aim of this study is to evaluate the effects of shunting on neuropsychological performance in NPH patients, using a computerized battery. 2. Feasibility. The ability to complete the test battery by the intended patient group will be tested. 3. Baseline profile. Baseline scores for NPH-patients will be compared to scores of healthy individuals (from previous study).