Non-Invasive Pressure Monitor for Hydrocephalus
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. The main questions it aims to answer are: * Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without * Can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments Participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the medical team conducting the trial.
What data supports the effectiveness of the treatment Non-Invasive Pressure Monitor for Hydrocephalus?
Research shows that non-invasive methods for monitoring intracranial pressure (pressure inside the skull) can be useful, especially in emergencies where invasive methods are not possible. These methods, like using ultrasound to measure the optic nerve sheath diameter, help estimate pressure changes and could be beneficial for managing conditions like hydrocephalus.12345
Is the Non-Invasive Pressure Monitor for Hydrocephalus safe for humans?
How does the non-invasive pressure monitor treatment for hydrocephalus differ from other treatments?
The non-invasive pressure monitor for hydrocephalus is unique because it allows for safe and repeated measurements of intracranial pressure (pressure inside the skull) without the need for surgical procedures, unlike traditional methods that often involve implantable devices or shunts. This approach reduces the risk of infections and complications associated with invasive techniques.1281112
Research Team
Jignesh Tailor
Principal Investigator
Indiana University
Eligibility Criteria
This trial is for newborns and infants at risk of hydrocephalus, a condition where fluid builds up in the brain. They must be undergoing standard care for hydrocephalus to participate. The study excludes those who do not meet the specific criteria set by researchers.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Evaluation
Participants undergo standard of care evaluations for hydrocephalus, including anterior fontanelle assessment and head circumference measurement, while wearing the device
Pre- and Post-Operative Monitoring
Participants are monitored with the device before and after surgical interventions such as ventricular reservoir taps or shunt surgeries
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Non-Invasive Pressure Monitor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor