Clinical trials: Water on the Brain
Intracranial Hypertension, Brain Injuries
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
Invasive 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.
- Conditions
- Intracranial Hypertension, Brain Injuries, Stroke, Hydrocephalus
- Trial name
- NCT02773888
- Testing
- HS-1000
- Where
- 5 sites in Japan
- Volunteers
- 80 people
- Sponsor
- HeadSense Medical
Hydrocephalus
ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients
The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH)…
- Trial name
- SCNPH (NCT01323764)
- Testing
- ShuntCheck test
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NeuroDx Development
Hydrocephalus
Assessment of CSF Shunt Flow in an Outpatient Setting with a Thermal Measurement Device
This study collects exploratory data using a non-invasive device for assessing CSF shunt flow using thermal anisotropy measurements.
- Trial name
- NCT06753929
- Testing
- wireless wearable thermal anisotropy measurement device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
CRT ShuntCheck "Fit & Function" Study
An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in hydrocephalus patients.
- Trial name
- NCT02067364
- Testing
- Fit & Function test
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- NeuroDx Development
Hydrocephalus
A Study on the Safety of Hakim Programmable Shunt System
This study aimed to collect safety information from subjects implanted with a shunt system (trade name: Hakim Shunt Programmable System) produced by Codman \& Shurtleff, Inc. of the United States.
- Trial name
- NCT04285489
- Testing
- Hakim Shunt Programmable System
- Where
- 5 sites in China
- Volunteers
- 130 people
- Sponsor
- Integra LifeSciences Corporation
Hydrocephalus, Normal Pressure, Hydrocephalus
Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure.
- Trial name
- NCT05250505
- Testing
- eShunt Implant
- Where
- Argentina
- Volunteers
- 30 people
- Sponsor
- CereVasc Inc
Normal Pressure Hydrocephalus
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
- Trial name
- STRIDE (NCT06498960)
- Testing
- CereVasc eShunt System, VP Shunt
- Where
- 32 sites in United States, Argentina and 1 more
- Volunteers
- 230 people
- Sponsor
- CereVasc Inc
Hydrocephalus, Hydrocephalus in Children
A Study Evaluate Aqueduct's Smart External Drain
To evaluate the performance characteristics of the Smart External Drain (SED) compared with standard EVD drains in the hospital setting, specifically: Number, type and duration of staff interactions.
- Conditions
- Hydrocephalus, Hydrocephalus in Children, Tumor, Brain
- Trial name
- SED (NCT03113799)
- Testing
- Smart External Drain - SED
- Where
- 2 sites in United States
- Volunteers
- 56 people
- Sponsor
- Aqueduct Critical Care
Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus (NPH) Registry
The overall aim of the registry is to develop a longitudinal, observational database that is focused on adult patients with Normal Pressure Hydrocephalus (NPH) that can be used as a source of clinical information for individual…
- Trial name
- NCT00233701
- Where
- 28 sites in United States
- Volunteers
- 343 people
- Sponsor
- Codman & Shurtleff
CSF Flow Through the Shunt of a Hydrocephalus Patient
Physician Preference Study of ShuntCheck - Madsen
ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.
- Trial name
- NCT00583336
- Testing
- ShuntCheck
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- NeuroDx Development
Hydrocephalus, NPH (Normal Pressure Hydrocephalus)
CERTAS Programmable Valve Registry
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
- Conditions
- Hydrocephalus, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension
- Trial name
- CERTAS (NCT04207229)
- Testing
- CODMAN CERTAS Programmable Valves
- Where
- 8 sites in Germany, Netherlands
- Volunteers
- 35 people
- Sponsor
- Integra LifeSciences Corporation
Hyponatremia, Dilutional Hyponatremia
Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction.
- Conditions
- Hyponatremia, Dilutional Hyponatremia, Inappropriate ADH Syndrome
- Trial name
- SALACIA (NCT01227512)
- Testing
- tolvaptan, Fluid Restriction
- Where
- 56 sites in United States
- Volunteers
- 124 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hydrocephalus
Functional and Non-Functional CSF Shunt Flow Measured With a Second-Generation Wireless Thermal Device
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of known non-functional and functional implanted shunts will assess the diagnostic…
- Trial name
- NCT06506045
- Testing
- FlowSense
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Rhaeos, Inc.
Brain Injuries, Subarachnoid Hemorrhage
An Evaluation of a Non-invasive Brain Monitor
HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal…
- Conditions
- Brain Injuries, Subarachnoid Hemorrhage, Vasospasm, Intracranial, Hydrocephalus
- Trial name
- NCT02775136
- Testing
- HS-1000 recording
- Where
- 4 sites in Germany
- Volunteers
- 160 people
- Sponsor
- HeadSense Medical
Hydrocephalus
A Prospective Study Comparing CSF Shunt Flow Between "Virtual Off" and "Flow Permissive" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor
Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can…
- Trial name
- NCT07815314
- Testing
- Rhaeos Shunt Monitoring System (RSMS), ShuntCheck III
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability
The study hypothesis is that nurses and doctors can use a transcutaneously powered ultrasonic flow sensor to make repeatable and accurate hydrocephalic shunt flow measurements.
- Trial name
- NCT00651950
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Transonic Systems Inc.