Clinical trials: Intracranial Pressure
Brain Injuries, Intracranial Hypertension
Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical…
- Trial name
- NCT02772471
- Testing
- HS-1000
- Where
- Norway
- Volunteers
- 40 people
- Sponsor
- HeadSense Medical
Intracranial Hypertension, Abnormality of Intracranial Pressure
Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device
For purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (ICP) device, with the values obtained from (a) patients in…
- Trial name
- NCT03865576
- Testing
- Non-invasive ICP measurement
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Boston Neurosciences
Intracranial Pressure Increase
Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure
The study is a prospective, multi-center, non-randomized, open label observational study. The objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of abnormal ICP as determined by an external…
- Trial name
- NCT03418753
- Testing
- EyeBOX for ICP
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Oculogica, Inc.
Brain Concussion, Brain Injuries
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
The HS-1000 is an innovative non-invasive monitoring device that employs advanced acoustic signal analysis to calculate ICP on a continuous basis.
- Trial name
- NCT02699359
- Testing
- HS-1000 recording
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- HeadSense Medical
Head Injury
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial…
- Trial name
- NCT01824589
- Testing
- -7 cm H2O ITPR, -12cm H2O ITPR
- Volunteers
- 1 people
- Sponsor
- Advanced Circulatory Systems
Traumatic Brain Injury
An Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of JNJ-17299425 in Participants With Traumatic Brain Injury
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (explores what the body does to the drug) and pharmacodynamics (the study of the action or effects a drug has on the body) of JNJ-17299425 in…
- Trial name
- NCT01814982
- Testing
- JNJ-17299425
- Where
- 11 sites in Belgium, France
- Volunteers
- 7 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Presence of High Intracranial Pressure
An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) 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.
- Trial name
- NCT02284217
- Testing
- EVD
- Where
- 7 sites in United States, Germany
- Volunteers
- 100 people
- Sponsor
- HeadSense Medical
Intracranial Hypertension
Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients
The purpose of this study is to prospectively evaluate the accuracy and safety of non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000) device compared to the current invasive external…
- Trial name
- NCT02695264
- Testing
- HS-1000 recording
- Where
- United States
- Sponsor
- HeadSense Medical
Traumatic Brain Injury
Study of Oxycyte in Severe Closed Head Injury
Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that die with severe head injuries. Laboratory studies in animals and clinical trials have shown that increasing oxygen in the brain results in…
- Trial name
- NCT00174980
- Testing
- Oxycyte
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Tenax Therapeutics, Inc.
Brain Injuries, Intracranial Hypertension
Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring
Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure (ICP) is measured.
- Trial name
- NCT02773862
- Testing
- HS-1000
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- HeadSense Medical
Intracranial Pressure
Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients
Intracranial pressure (ICP) monitoring is indicated in a wide range of neurological diseases. The combination of a linear ultrasound array with an integrated pressure sensor into a single handheld probe (ICP Probe) enables the…
- Trial name
- VENUS-ICPxP (NCT07550361)
- Testing
- CPMX3 measurement
- Where
- United States
- Sponsor
- Compremium AG
Intracranial Pressure, Intracranial Pressure Changes
CoMind Early Feasibility Study
The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around…
- Conditions
- Intracranial Pressure, Intracranial Pressure Changes, Traumatic Brain Injury, Intracerebral Hemorrhage
- Trial name
- CoMind EFS (NCT06368648)
- Where
- 17 sites in United States
- Volunteers
- 581 people
- Sponsor
- CoMind Technologies Limited
Traumatic Brain Injury, Intracranial Hypertension
A Non-invasive Intracranial Pressure (nICP) Monitoring System
Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe.
- Trial name
- NCT05632302
- Testing
- nICP
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Crainio Ltda
Intracranial Hypertension
Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
In current practice patients with a suspected increase of intracranial pressure (ICP) will undergo a lumbar puncture with measurement of cerebral spinal fluid (CSF) pressure (as a marker for ICP).
- Trial name
- NCT02773901
- Testing
- HS-1000
- Where
- 3 sites in Denmark, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- HeadSense Medical
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, Hydrocephalus in Children
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
- Conditions
- Hydrocephalus, Hydrocephalus in Children, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension
- Trial name
- NCT05397106
- Testing
- CODMAN CERTAS Plus Programmable Valve
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 160 people
- Sponsor
- Integra LifeSciences Corporation
Traumatic Brain Injury (TBI) Patients, Stroke Hemorrhagic
Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
The goal of this observational study is to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) pulse morphology and associated parameters (such as the P2/P1 ratio and…
- Conditions
- Traumatic Brain Injury (TBI) Patients, Stroke Hemorrhagic, Stroke Ischemic
- Trial name
- NCT07210333
- Testing
- non-invasive intracranial pressure monitoring
- Where
- 3 sites in Brazil
- Volunteers
- 300 people
- Sponsor
- Braincare USA Corp
Hypertension, Hemorrhage
Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)
The purpose of this study was to determine the efficacy and safety of clevidipine for treating acute hypertension (high blood pressure, defined as systolic blood pressure >160 mmHg) in patients with intracerebral hemorrhage…
- Trial name
- ACCELERATE (NCT00666328)
- Testing
- clevidipine
- Where
- 17 sites in United States, Germany
- Volunteers
- 37 people
- Sponsor
- The Medicines Company
Head Injury, Intracranial Pathology
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion
The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation.
- Conditions
- Head Injury, Intracranial Pathology, Compromised Cerebral Perfusion
- Trial name
- NCT01824576
- Testing
- ITPR
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Advanced Circulatory Systems
Intracranial Pressure
Safety Study to Evaluate Intracranial Pressure During High Frequency Chest Wall Oscillation
The purpose of this study is to evaluate changes in intracranial pressure (ICP) during or immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™ in neurosurgical subjects.
- Trial name
- NCT00279097
- Testing
- High Frequency Chest Wall Oscillation
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Hill-Rom