Non-Invasive ICP Monitoring Study
ConditionIntracranial Pressure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
Measuring the pressure inside the skull, which is called intracranial pressure, is important to treat severe neurological illness. Currently, measuring intracranial pressure requires doctors to place an invasive pressure monitor. Recently, a non-invasive intracranial pressure monitor has been developed. This monitor has a tiny pin that is placed on the head which measures the tiny movements of the skull every time the heart beats. This produces a waveform that looks very similar to an invasive intracranial pressure waveform. However, we don't know enough about how the non-invasive device to make it clinically useful yet.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (age >18) undergoing craniotomy for any indication requiring hyperosmolar agents as a part of their surgery
Adult patients (age >18) in the neuro-oncology or neurosurgery clinic who are receiving diagnostic/therapeutic lumbar puncture as a part of their ordinary care
Adult patients (age >18) in the neurosurgery clinic with ventriculo-peritoneal shunts who require adjustments to increase or decrease drainage of cerebrospinal fluid.
Disqualifiers
Age <18
Lacking capacity to provide informed consent on their own behalf
Trial population
Clinical
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Brain4Care
DeviceNon-invasive intracranial pressure monitor
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
P2/P1 Ratio
Time frame
Subject enrollment to study completion up to 100 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov