Non-Invasive Pressure Monitor for Hydrocephalus

Overseen By Clinical Research Coordinator

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Hypersensitivity, Fontanelle wounds, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device—a smart soft contact lens—to monitor pressure changes in infants with hydrocephalus, a condition where fluid accumulates in the brain. The lens aims to detect pressure differences in infants with and without hydrocephalus and observe pressure changes before and after surgery. The study includes several groups: infants at risk for hydrocephalus, those undergoing surgery, and healthy controls. Participants should be infants monitored for hydrocephalus or healthy controls, without known allergies to the contact lens materials and no closed soft spots on the head (fontanelles). As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance monitoring and treatment for infants with hydrocephalus.

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 prior data suggests that this non-invasive pressure monitor is safe for neonates and infants?

Research has shown that non-invasive pressure monitors are generally safe. These devices measure pressure inside the skull without surgery and carry a low risk of serious complications. Some minor issues have been reported, but they were not serious. This technology aims to avoid the risks linked to invasive methods. The strong safety record of non-invasive monitors makes them a promising option for infants at risk of hydrocephalus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the non-invasive pressure monitor for hydrocephalus because it offers a less intrusive way to measure intracranial pressure (ICP) compared to traditional methods like external ventricular drains (EVDs) and reservoir taps that involve surgery. This monitor allows for continuous ICP monitoring without the need for invasive procedures, which can reduce the risk of infection and other complications. Additionally, it could provide more consistent and accurate data by allowing frequent assessments, potentially leading to better management of hydrocephalus. Overall, this method could revolutionize how doctors assess and treat the condition, making it safer and more comfortable for patients.

What evidence suggests that this device is effective for monitoring hydrocephalus?

Research has shown that non-invasive pressure monitors can effectively track changes in intracranial pressure. One study found these devices to be generally safe, with a low risk of serious complications. They can detect pressure changes, crucial for conditions like hydrocephalus, where fluid accumulates in the brain. This trial will evaluate the effectiveness of a non-invasive pressure monitor in various scenarios, including standard care monitoring and surgical procedures. Although invasive methods remain the most reliable, non-invasive monitors offer a promising alternative for tracking pressure without surgery. Early findings suggest they might estimate pressure changes by analyzing blood pressure patterns, making them a valuable tool for managing hydrocephalus in infants. ^{1 2 3 5 6}

Who Is on the Research Team?

Jignesh Tailor

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Aim 4 Hydrocephalus, Reservoir surgery Experimental Treatment 1 Intervention

Intervention pre- and post- ventricular reservoir tap(s)

Group II: Aim 3 Hydrocephalus, EVD ICP monitor Experimental Treatment 1 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 surgery Experimental Treatment 1 Intervention

Intervention pre- and post-operatively

Group IV: Aim 1 Hydrocephalus Experimental Treatment 1 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 Control Active Control 1 Intervention

Intervention at single time point not to interfere with standard of care procedures

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3376474/

Intracranial Pressure Monitoring: Invasive versus Non ... This paper aims to provide an overview of the advantages and disadvantages of the most common and well-known methods as well as assess whether noninvasive ...

2. fluidsbarrierscns.biomedcentral.com fluidsbarrierscns.biomedcentral.com/articles/10.1186/s12987-025-00632-1

Research priorities for non-invasive therapies to improve ... A current key research priority is to assess the efficacy of these proposed therapies to control ventricular size, minimize acute damage, ...

3. withpower.com withpower.com/trial/phase-hydrocephalus-3-2024-0fcf9

Non-Invasive Pressure Monitor for Hydrocephalus Research on non-invasive intracranial pressure monitoring suggests it is generally safe, with low risk of serious complications. In one study, minor issues ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0952818025002387

Non-invasive intracranial pressure assessment in adult ... Intracranial hypertension is a severe complication in acute brain injured patients worsening outcomes. •. Invasive measurement is the gold standard but it is ...

5. nature.com nature.com/articles/s41598-018-23142-7

Non-invasive Estimation of the Intracranial Pressure ... The presented data show some promise regarding the ability of central aortic BP waveforms to non-invasively estimate the ICP waveform. The ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2503109

A Randomized Trial of Shunting for Idiopathic Normal ... Prespecified safety outcomes included total reported falls, clinically significant falls, surgical complications, and complications related to ...