25 Participants Needed

Non-Invasive Pressure Monitor for Hydrocephalus

CR
Overseen ByClinical Research Coordinator
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research on non-invasive intracranial pressure monitoring suggests it is generally safe, with low risk of serious complications. In one study, minor issues occurred in 7% of patients, but no major adverse events were reported.678910

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

JT

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

Healthy controls
Being monitored for hydrocephalus

Exclusion Criteria

Other conditions deemed relevant by the medical team
Known hypersensitivity to materials used in the contact lens and/or adhesive
I have wounds near the soft spot on the top of a baby's head.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Evaluation

Participants undergo standard of care evaluations for hydrocephalus, including anterior fontanelle assessment and head circumference measurement, while wearing the device

1 day
1 visit (in-person)

Pre- and Post-Operative Monitoring

Participants are monitored with the device before and after surgical interventions such as ventricular reservoir taps or shunt surgeries

Up to 48 hours per procedure
Multiple visits (in-person) as per surgical schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Non-Invasive Pressure Monitor
Trial Overview Researchers are testing a new non-invasive pressure monitor using a smart soft contact lens to track changes in brain pressure in babies with and without hydrocephalus, before and after surgery or other treatments.
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Group I: Aim 4 Hydrocephalus, Reservoir surgeryExperimental Treatment1 Intervention
Intervention pre- and post- ventricular reservoir tap(s)
Group II: Aim 3 Hydrocephalus, EVD ICP monitorExperimental Treatment1 Intervention
Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference)
Group III: Aim 2 Hydrocephalus, Shunt surgeryExperimental Treatment1 Intervention
Intervention pre- and post-operatively
Group IV: Aim 1 HydrocephalusExperimental Treatment1 Intervention
Intervention at single time point during standard of care hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference), unless further assigned to supplemental arm following standard of care surgical procedure
Group V: Aim 1 ControlActive Control1 Intervention
Intervention at single time point not to interfere with standard of care procedures

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

References

Continuous intracranial pressure recording in adult hydrocephalus. [2006]
Single center experiences with telemetric intracranial pressure measurements in patients with CSF circulation disturbances. [2021]
[Non-invasive evaluation of intracranial pressure: how and for whom?]. [2016]
Telemetric implantable pressure sensor for short- and long-term monitoring of intracranial pressure. [2020]
Intracranial pressure changes during intermittent CSF drainage. [2019]
Complications of elective intracranial pressure monitoring in adult hydrocephalus. [2021]
First clinical results with a telemetric shunt-integrated ICP-sensor. [2019]
8.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Non-invasive monitoring of intracranial pressure]. [2016]
A telemetric pressure sensor system for biomedical applications. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Discrepancy Between Internal and External Intracranial Pressure Transducers: Quantification of an Old Source of Error in EVDs? [2020]
Implantable ICP monitor for improved hydrocephalus management. [2012]
Prediction of intracranial hypertension through noninvasive intracranial pressure waveform analysis in pediatric hydrocephalus. [2020]
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