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Diagnostic Device

Non-Invasive Intracranial Pressure Measurement for Intracranial Hypertension (ICP Waveform Trial)

N/A

Recruiting

Led By Igor Nestrasil, MD, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

Must not have

Diagnosis of retinopathy

Diagnosis of head tremor.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants in the healthy control and intra-group verification arms will be enrolled for one day. transfer function estimation subjects will be enrolled for up to 14 days.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new, non-invasive way to measure pressure inside the skull, which could be helpful for patients with certain conditions.

Who is the study for?

This trial is for individuals who can remain still and focus on a target during the video ophthalmoscope (VO) procedure. It's specifically for those with intracranial hypertension who already have an ICP probe inserted for clinical reasons. People with retinopathy, head tremor, or glaucoma cannot participate.

What is being tested?

The study is testing a non-invasive technique using a video ophthalmoscope to measure intracranial pressure waveforms without touching the eye or needing anesthesia.

What are the potential side effects?

Since the method being tested is non-contact and non-invasive, significant side effects are not expected. However, discomfort from sitting still and focusing during the procedure may occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with retinopathy.

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I have been diagnosed with head tremor.

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I have been diagnosed with glaucoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants in the healthy control and intra-group verification arms will be enrolled for one day. transfer function estimation subjects will be enrolled for up to 14 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants in the healthy control and intra-group verification arms will be enrolled for one day. transfer function estimation subjects will be enrolled for up to 14 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants in the healthy control and intra-group verification arms will be enrolled for one day. transfer function estimation subjects will be enrolled for up to 14 days. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The study will look at whether retinal video-recordings can be used to help estimate intracranial pressure.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Transfer Function EstimationExperimental Treatment1 Intervention

Subjects in the second phase of the experiment (70 subjects total) will be randomized to either Group A or Group B. We anticipate that 25 adult and 10 pediatric (ages 4-17) patients will participate in each group. Individuals in Group A will have two inter-leaved examinations (1-14 days apart). Data from the first examination will serve for SVP-ICP transfer function estimation and data from the second examination will serve for the intra-group verification for the estimated transfer function.

Group II: Intra-Group VerificationExperimental Treatment1 Intervention

Individuals in Group B will undergo one examination. Data from Group B participants will serve as the inter-group re-test verification of the estimated transfer function.

Group III: Healthy ControlsExperimental Treatment1 Intervention

In the first phase of the experiment, 20 healthy controls will test the VO device to determine whether the camera with a CCD or CMOS lens is the most appropriate for use in ICP patients and to synchronize the VO, ECG, PPG, IOP and respiratory signals.

0 / 3Eligibility criteria met