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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
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
ICP Waveform Trial 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.Check my eligibility
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.See study design
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.
ICP Waveform Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The study will look at whether retinal video-recordings can be used to help estimate intracranial pressure.
ICP Waveform 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.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,685 Total Patients Enrolled
Igor Nestrasil, MD, PhDPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with retinopathy.You need to have a special probe inserted for medical reasons.I can sit still and focus on a specific point when needed.I have been diagnosed with head tremor.I have been diagnosed with glaucoma.
Research Study Groups:
This trial has the following groups:- Group 1: Transfer Function Estimation
- Group 2: Healthy Controls
- Group 3: Intra-Group Verification
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate amount of participants in this medical trial?
"Affirmative. Clinicaltrials.gov indicates that this clinical trial is presently recruiting patients, with 90 participants sought from 1 location since its initial posting on August 31st 2019 and last update September 16th 2022."
Answered by AI
Is this clinical examination recruiting new participants?
"According to the details on clinicaltrials.gov, this research project is currently open for enrollment and has been since its inception in August 2019 with a recent revision taking place in September 2022."
Answered by AI
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