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Hydrocephalus, Normal Pressure clinical trials

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NCT ID: NCT03521518 Terminated - Clinical trials for Normal Pressure Hydrocephalus

CPT-3 in Normal Pressure Hydrocephalus

Start date: January 16, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT03076723 Terminated - Clinical trials for Hydrocephalus, Normal Pressure

Using Cerebrospinal Fluid Dynamics to Optimize Treatment of Idiopathic Normal Pressure Hydrocephalus

PULSE-OPT
Start date: June 13, 2017
Phase: N/A
Study type: Interventional

The 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: 1. 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. 2. 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: 1. To determine if improvement three month after surgery is associated with postoperative reduction in pulse amplitude. 2. To determine if a pulsatility curve obtained preoperatively can predict improvement in gait velocity and cognitive functions in INPH patients three months after surgery. 3. 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.

NCT ID: NCT02163330 Terminated - Clinical trials for Motor Condition as Measured by Quantified Scale

Normal Pressure Hydrocephalus Treatment by Acetazolamide

Start date: June 2014
Phase: Phase 3
Study type: Interventional

Normal pressure hydrocephalus (NPH) is an uncommon cause of dementia possibly reversible with treatment. First described in 1965 it consists of a triad of gait disturbance, cognitive deterioration, and urinary incontinence together with enlarged cerebral ventricles and normal cerebrospinal fluid (CSF) pressure. Foregoing trauma and hemorrhage, infection, mass lesions, or aqueductal stenosis can contribute to hydrocephalus. These symptomatic or secondary forms of NPH are not considered here and the focus lies on the idiopathic type (iNPH). Prevalence of iNPH increases significantly with age. General estimates range from 21.9 per 100,000 in total population surveys but increase up to 181.7 per 100,000 for people 70 to 79 years of age. The clinical presentation varies significantly in severity and progression of symptoms. For diagnosis the entire triad does not have to be present. In typical cases gait and balance disturbances appear either before or concurrently with urinary incontinence or the onset of dementia. Current treatment recommendations are based on surgical diversion of CSF , with shunts placed either into the ventricular system or the lumbar subarachnoid space to a distal site, such as the peritoneal or the pleural cavity or the venous system, where the CSF can be reabsorbed . Even though immediate response rate to shunt treatment might be favorable and rates of 80% responders have been reported , the perioperative and long-term morbidity and mortality of CSF shunting procedures are significant. A meta-analysis of 44 articles found that the pooled, mean rate of shunt complication was 38% . Even though acute surgical complication rates are low, shunt dysfunctions and long-term complications are relatively common. Shunt malfunction (20%), subdural hematoma (2-17%), seizure (3-11%), shunt infection (3-6%) and intracerebral hematoma (3%) are the most common complications . In those with good long-term survival, sustained improvement is possible, with a rate of 39% documented after 5 years .In view of the complication rates, the lack of alternative treatment options and clinical studies is surprising. Even though iNPH per definition lacks raised intracranial pressure on spinal tap, monitoring of ICP prior to surgery reveals an increased amount of brief (usually 30 seconds to 1 minute) increases in the static ICP, called Lundberg B waves, in patients which improve by shunt placements . When patients are scheduled for shunt treatment there is a waiting period of several weeks between diagnosis and operation due to congested waiting list. Acetazolamide (Diamox) 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 pressure (pseudotumor cerebri). Intuitively a connection between Acetazolamide as a treatment option in iNPH seems logical. Encouraging case studies have been published previously showing a fascinating improvement and success of treating iNPH with Acetazolamide. A systematic placebo controlled study concerning the use of Acetazolamide in iNPH is missing and would possibly pave the way to an alternative treatment option avoiding surgery and its complications.

NCT ID: NCT01834625 Terminated - Clinical trials for Normal Pressure Hydrocephalus Patients

Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

Start date: April 2013
Phase:
Study type: Observational

In this pilot study the investigators shall prospectively in a blinded fashion evaluate with Aβ PET in patients committed to shunt surgery and then investigate the relationship of these biomarkers with outcome on gait, cognition and urinary control improvement in the short term (3 months) and long term (1 year). The imaging agent will be provided by AVID. Furthermore the study will standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden.

NCT ID: NCT01092546 Terminated - Clinical trials for Normal Pressure Hydrocephalus

Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Start date: March 2010
Phase: Phase 3
Study type: Interventional

To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.

NCT ID: NCT00946127 Terminated - Hydrocephalus Clinical Trials

ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

Start date: March 2009
Phase: Phase 3
Study type: Observational

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.

NCT ID: NCT00727142 Terminated - Clinical trials for Normal Pressure Hydrocephalus

Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus (INPH)

Start date: July 2008
Phase: N/A
Study type: Interventional

This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.

NCT ID: NCT00613886 Terminated - Clinical trials for Normal Pressure Hydrocephalus

Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus

NPH
Start date: March 2006
Phase: N/A
Study type: Interventional

The research project is designed to determine which combination of tests will enable physicians to predict whether a patient with symptoms of normal pressure hydrocephalus (NPH) will improve with a shunt.

NCT ID: NCT00149721 Terminated - Clinical trials for Normal Pressure Hydrocephalus

Anterior Pituitary Function in Patients With Hydrocephalus

Start date: September 2005
Phase: N/A
Study type: Interventional

Hydrocephalus (secondary or idiopathic) is a condition characterized by dilatation of the lateral and third ventricles, and often associated with increased intracranial pressure (ICP). We hypothesize that either the ventricle dilatation or the increased ICP may cause disturbances in the hypothalamic-pituitary axis, resulting in different degrees of hypopituitarism. The goal of this study is to determine the prevalence of hypopituitarism in adult patients with hydrocephalus.