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Hydrocephalus clinical trials

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NCT ID: NCT05501002 Terminated - Hydrocephalus Clinical Trials

Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus

Start date: September 15, 2022
Phase: N/A
Study type: Interventional

The purpose of this study will be to evaluate a novel, minimally invasive method of treating hydrocephalus in adults. The eShunt® System includes a proprietary eShunt® Delivery System and the eShunt® Implant, a permanent implant that is deployed in a mildly invasive, neuro-interventional procedure. The eShunt® Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.

NCT ID: NCT03698838 Terminated - Epilepsy Clinical Trials

Myelin Imaging Changes In Patients With Neurosurgical Diseases

McDESPOT
Start date: February 12, 2019
Phase:
Study type: Observational

Investigate myelin alterations in patients with neurosurgical diseases

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: NCT03471702 Terminated - Clinical trials for Subarachnoid Hemorrhage

A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)

Start date: February 28, 2018
Phase: N/A
Study type: Interventional

Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for temporary CSF management in a hospital setting. - Evaluate the number of subjects requiring to be switched to a standard of care EVD - Evaluate subject transport while on the SED - Evaluate SED system control from initiation of SED through discharge of external drain system

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: NCT02900222 Terminated - Hydrocephalus Clinical Trials

Study of Choroid Plexus Cauterization in Patients With Hydrocephalus

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT02737163 Terminated - Hydrocephalus Clinical Trials

Strata Programmable CSF Shunt Valve Study

Start date: April 1, 2016
Phase:
Study type: Observational

The treatment of hydrocephalus is the most time consuming, and arguably the most important role of the pediatric neurosurgical service at most children's' hospitals. Despite many technological advances, cerebral spinal fluid (CSF) shunting procedures remain the mainstay of hydrocephalus treatment. While often lifesaving, CSF shunting procedures are associated with high complication rates and account for a disproportionate share of health care expenditures and morbidity. Programmable CSF shunt valves, through which CSF flow and pressure can be adjusted by quick and painless transcutaneous reprogramming, have been implanted for more than 15 years in the developed world. Reprogramming these valves relies on rotational magnetic forces, which are applied by neurosurgeons and neurosurgical advanced practice providers. Inadvertent reprogramming (IR) can occur when patients with these valves are exposed to magnetic fields in the environment, which may lead to serious symptoms that may require urgent reprogramming and/or surgery. The concurrent proliferation of magnetically sensitive programmable CSF shunt valves and household items that generate substantial magnetic fields has caused concern among patients, parents and providers about the potential consequences of inadvertent valve reprogramming. This growing concern led the FDA to issue a warning to individuals with programmable valves in 2014, which deemed the programmable valves safe for use but vulnerable to IR when household devices such as tablets or cell phones are placed within 2 inches of the valve. The FDA recommended further study, stating that no systematic evaluation had been performed regarding the prevalence of accidental valve adjustments. By evaluating each of the patients with magnetically susceptible CSF shunt valves, during each of the routine points of contact with the service, investigators aim to define the prevalence of inadvertent shunt reprogramming, to correlate with the presence and absence of symptoms and radiographic changes, and to evaluate the risk of inadvertent shunt reprogramming based on exposure to common environmental items.

NCT ID: NCT02512809 Terminated - Hydrocephalus Clinical Trials

Isoflurane-induced Neuroinflammation in Children With Hydrocephalus

Start date: July 2015
Phase: Phase 3
Study type: Interventional

The investigators will quantify inflammatory biomarkers in cerebrospinal fluid (CSF) and serum of children with hydrocephalus who are undergoing ventriculoperitoneal shunt placement under isoflurane anesthesia.

NCT ID: NCT02408757 Terminated - Hydrocephalus Clinical Trials

Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages

Start date: September 2015
Phase:
Study type: Observational

As elaborated above only one study reported ultrasonographic changes of the width of the lateral ventricle during clamping of EVD/LD and indicated that ultrasound monitoring might be suitable. No firm data exists about the change of the width of the third ventricle, the diameter of the optic nerve or brain perfusion during clamping of the EVD/LD, although the width of these structures has been shown to depend on intracranial pressure. Ultrasonographic measurements of changes of the width of the third ventricle or the diameter of the optic nerve would have some advantages compared to the ultrasonographic assessments of the lateral ventricles. First, the width of the third ventricle can be measured easier and more reliable than the width of the lateral ventricles (better defined insonation plane and therefore higher repeatability of measurements) 3. Second, whereas assessments of the width of the side and third ventricles with ultrasound depend on the temporal bone windows (10 to 15% of patients have insufficient temporal bone windows), the measurement of the diameter of the optic nerve does not have this limitation and can therefore be performed in almost all patients. Hence, measurement of the diameter of the optic nerve would allow to overcome one major limitation of transcranial ultrasound. The latter limitation for transcranial ultrasound could also be minimized by the use of an ultrasound contrast agent (SonoVue®), but this was also not yet studied. The use of an ultrasound contrast agent would in addition allow to study changes of brain perfusion during clamping of EVD/LD.

NCT ID: NCT02386228 Terminated - Spina Bifida Clinical Trials

Micro Ribonucleic Acid (miRNA) Markers of Hydrocephalus in Intraventricular Hemorrhage (IVH)

Start date: March 2015
Phase: N/A
Study type: Observational

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.