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Non-Invasive Pressure Monitor for Hydrocephalus

N/A

Waitlist Available

Led By Jignesh Tailor

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up continuously measured for up to 24 hours prior to shunt surgery and continuously measured for up to 24 hours after shunt surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a modified smart soft contact lens in newborns and infants at risk of hydrocephalus. It will determine if the device can differentiate between pressure changes in infants with hydrocephalus

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this device is non-invasive and used only during evaluations, side effects may be minimal but could include discomfort from wearing the contact lens or skin irritation around the eye area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuously measured for up to 24 hours prior to reservoir tapping and continuously measured for up to 24 hours after reservoir tapping

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~continuously measured for up to 24 hours prior to reservoir tapping and continuously measured for up to 24 hours after reservoir tapping

This trial's timeline: 3 weeks for screening, Varies for treatment, and continuously measured for up to 24 hours prior to reservoir tapping and continuously measured for up to 24 hours after reservoir tapping for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1)

Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after reservoir taps (Aim 4)

Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after shunt surgery (Aim 2)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

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