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Trial record 4 of 43 for:    Recruiting, Not yet recruiting, Available Studies | Intracranial pressure

Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy (ICP Waveform)

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ClinicalTrials.gov Identifier: NCT04046523
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
This study will test the use of video ophthalmoscope to provide information about intracranial pressure without the use of invasive methods, anesthesia or contact with the eye.

Condition or disease Intervention/treatment Phase
Intracranial Pressure Increase Device: Video ophthalmoscope Not Applicable

Detailed Description:
The monitoring of intracranial pressure (ICP) is crucial in head injuries and pathologies such as brain edema, arachnoid cyst, craniosynostosis or, in very-low-birthweight infants, post-hemorrhagic hydrocephalus. Some current methods of ICP are invasive and, in the case of lumbar puncture, require anesthesia, which can distort the measurement by 5-10 mmHg. The golden clinical standard is direct measurement using a surgically-implanted intraventricular drain connected to an external pressure transducer ("ICP probe"). However, this method carries risks such as hemorrhage, malfunction, obstruction or infection . The risk in pediatric patients is up to 5% and in adults the risk of fatal hemorrhage is 4-5% in patients with subdural and intraparenchymal monitoring devices. Due to these risks and the financial burden on patients, there have been attempts to develop tools for non-invasive ICP estimation. This study will test the use of a video ophthalmoscope that will calculate the relative waveform of intracranial pressure and provide information about intracranial compliance without the use of anesthesia, invasive methods or contact with the eye.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

In the first phase of the experiment, a total of 20 healthy controls will test the VO device to determine which camera is the most appropriate for ICP patients and to synchronize the VO, electrocardiogram (ECG), photoplethysmography (PPG), intraocular pressure (IOP) and respiratory signals.

The second phase of the experiment will enroll a total of 70 subjects who are undergoing ICP monitoring with a surgically placed probe will be randomly assigned into one of two groups. Each group will consist of 25 adult and 10 pediatric (aged 4-17) participants. Group A will undergo two inter-leaved examinations (up to 14 days apart). Data from the first exam will be used for SVP-ICP transfer function estimation and data from the second exam will serve for intra-group verification of the estimated transfer function. Group B participants will undergo only one examination and their data will serve as an inter-group re-test verification of the estimated transfer function.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy
Actual Study Start Date : August 31, 2019
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Controls
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.
Device: Video ophthalmoscope
Use of a custom video ophthalmoscope with either a CCD or CMOS camera lens. The healthy controls group (first 20 subjects) will provide data to help determine which lens might be best for measuring ICP patients (Groups A and B) in the second phase of the study.

Experimental: Transfer Function Estimation
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.
Device: Video ophthalmoscope
Use of a custom video ophthalmoscope with either a CCD or CMOS camera lens. The healthy controls group (first 20 subjects) will provide data to help determine which lens might be best for measuring ICP patients (Groups A and B) in the second phase of the study.

Experimental: Intra-Group Verification
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.
Device: Video ophthalmoscope
Use of a custom video ophthalmoscope with either a CCD or CMOS camera lens. The healthy controls group (first 20 subjects) will provide data to help determine which lens might be best for measuring ICP patients (Groups A and B) in the second phase of the study.




Primary Outcome Measures :
  1. The study will look at whether retinal video-recordings can be used to help estimate intracranial pressure. [ Time Frame: 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 study will help determine whether there could be a less invasive method of monitoring intracranial pressure. It is thought that the use of a video-ophthalmoscope recordings could be utilized to measure intracranial pressure. The outcome measures will be provided as z-scores.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be able to sit still and fix their eyes on a target in the VO objective.
  • ICP participants must have an inserted ICP probe for clinical purposes.

Exclusion Criteria:

  • Diagnosis of glaucoma, retinopathy or head tremor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046523


Contacts
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Contact: Igor Nestrasil, MD, PhD 612-625-0496 nestr007@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Igor Nestrasil, MD, PhD    612-625-0496    nestr007@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Igor Nestrasil, MD, PhD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT04046523     History of Changes
Other Study ID Numbers: STUDY00006806
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
video ophthalmoscope
intraocular pressure
electrocardiogram
photoplethysmography
retinal pulsatility
spontaneous venous pulsation
blind source separation
Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases