Non-Invasive Intracranial Pressure Measurement for Intracranial Hypertension
(ICP Waveform Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Minnesota
Disqualifiers: Glaucoma, Retinopathy, Head tremor
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Video Ophthalmoscope, Dynamic Video Ophthalmoscope, Video Ophthalmoscopy Device for measuring intracranial pressure?
Research suggests that measuring intraocular pressure (pressure inside the eye) can help detect increased intracranial pressure (pressure inside the skull) noninvasively, which is important for early intervention in conditions like intracranial hypertension.
12345Is the non-invasive intracranial pressure measurement method safe for humans?
The non-invasive method for measuring intracranial pressure, which involves observing retinal blood vessels, is considered safe as it avoids the trauma and complications associated with invasive procedures like lumbar punctures.
36789How is the Video Ophthalmoscope treatment different from other treatments for intracranial hypertension?
The Video Ophthalmoscope treatment is unique because it offers a non-invasive way to measure intracranial pressure by observing changes in the eye, specifically using video technology to monitor retinal blood vessels. This approach avoids the need for invasive procedures like inserting sensors into the brain, making it safer and more comfortable for patients.
1481011Eligibility Criteria
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.Inclusion Criteria
You need to have a special probe inserted for medical reasons.
I can sit still and focus on a specific point when needed.
Exclusion Criteria
I have been diagnosed with retinopathy.
I have been diagnosed with head tremor.
I have been diagnosed with glaucoma.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Healthy Controls Testing
20 healthy controls test the VO device to determine the most appropriate camera lens and synchronize signals
1 day
1 visit (in-person)
Transfer Function Estimation
Subjects undergo two inter-leaved examinations for SVP-ICP transfer function estimation and intra-group verification
1-14 days
2 visits (in-person)
Intra-Group Verification
Group B participants undergo one examination for inter-group re-test verification of the estimated transfer function
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after testing
2 weeks
Participant Groups
The study is testing a non-invasive technique using a video ophthalmoscope to measure intracranial pressure waveforms without touching the eye or needing anesthesia.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
The relationship of intraocular pressure to intracranial pressure. [2019]The early detection of intracranial hypertension can lead to timely medical and neurosurgical intervention, preventing brain herniation and death. In this investigation, we hypothesize that an increase in intracranial pressure can be detected by an increase in intraocular pressure using noninvasive existing technology, the handheld tonometer.
Diagnostic accuracy of intraocular pressure measurement for the detection of raised intracranial pressure: meta-analysis: a systematic review. [2019]Because clinical examination and imaging may be unreliable indicators of intracranial hypertension, intraocular pressure (IOP) measurement has been proposed as a noninvasive method of diagnosis. The authors conducted a systematic review and meta-analysis to determine the correlation between IOP and intracranial pressure (ICP) and the diagnostic accuracy of IOP measurement for detection of intracranial hypertension.
Association of Intracranial Pressure and Spontaneous Retinal Venous Pulsation. [2021]A convenient and reliable method for noninvasive intracranial pressure assessments is desirable to reduce the need for invasive procedures (eg, intracranial pressure monitoring and lumbar punctures) and allow clinicians to identify and treat patients with intracranial hypertension in a timely manner.
Accuracy, Precision, Sensitivity, and Specificity of Noninvasive ICP Absolute Value Measurements. [2017]An innovative absolute intracranial pressure (ICP) value measurement method has been validated by multicenter comparative clinical studies. The method is based on two-depth transcranial Doppler (TCD) technology and uses intracranial and extracranial segments of the ophthalmic artery as pressure sensors. The ophthalmic artery is used as a natural pair of "scales" that compares ICP with controlled pressure Pe, which is externally applied to the orbit. To balance the scales, ICP = Pe a special two-depth TCD device was used as a pressure balance indicator. The proposed method is the only noninvasive ICP measurement method that does not need patient-specific calibration.
A Neuro-Ophthalmologist's Guide to Advances in Intracranial Pressure Measurements. [2023]Cerebrospinal fluid disorders have a wide-ranging impact on vision, headache, cognition and a person's quality of life. Due to advances in technology and accessibility, intracranial pressure measurement and monitoring, usually managed by neurosurgeons, are being employed more widely in clinical practice. These developments are of direct importance for Ophthalmologists and Neurologists because the ability to readily measure intracranial pressure can aide management decisions. The aim of this review is to present the emerging evidence for intracranial pressure measurement methods and interpretation that is relevant to Neuro-ophthalmologists.
Idiopathic intracranial hypertension: Update on diagnosis and management. [2021]Idiopathic intracranial hypertension is a condition of raised intracranial pressure of unknown cause. Features include new onset headache, which is frequently non-specific; papilloedema is present, visual disturbances are common; and there may be sixth nerve palsy. Diagnosis includes brain imaging with venography to exclude structural causes and venous sinus thrombosis. Lumbar puncture reveals pressure greater than 250 mmCSF with normal constituents. Treatments aim to modify the disease, prevent permanent visual loss and manage headaches. These include weight loss. For those with rapid visual decline, urgent surgical intervention is essential. For most, this is a chronic condition characterised by significantly disabling headaches.
Outcomes measures in idiopathic intracranial hypertension. [2022]Introduction: Idiopathic intracranial hypertension is a condition characterized by raised intracranial pressure, papilledema, and normal neuroimaging (aside from radiological signs of raised intracranial pressure). Symptoms of idiopathic intracranial hypertension include chronic headaches and for some, visual loss. New treatments are unmet clinical needs.Areas covered: The aim of this review is to present the evidence base and considered opinion on outcome measures to determine successful management of idiopathic intracranial hypertension.Expert opinion: Less invasive measures of disease activity such as optical coherence tomography will continue to grow in this field, both as a measure of papilledema, and potentially as a surrogate for intracranial pressure and visual function. As a highly disabling aspect of the disease is headache, treatment outcomes for headache morbidity need to be appropriately chosen and standardized to allow comparison between trials.
Non-Invasive Measurement of Intracranial Pressure Through Application of Venous Ophthalmodynamometry. [2022]Non-invasive intracranial pressure (ICP) monitoring is possible using venous ophthalmodynamometry to observe a pulsation in retinal blood vessels when intraocular pressure (IOP) exceeds ICP. Here, we identify features in the eye - optic disc and retinal blood vessel locations - and identify pulsation in large retinal blood vessels. The relationship between force and the magnitude of pulsation is used to estimate ICP when force is applied to the eye to gradually increase IOP over time. This approach yields 77% accuracy in automatically observing vessel pulsation.Clinical Relevance - Non-invasive ICP monitoring is desirable to improve patient outcome by reducing potential trauma and complications associated with invasive assessment with intracranial sensors or lumbar puncture.
Retinal vessel dynamics analysis as a surrogate marker for raised intracranial pressure in patients with suspected idiopathic intracranial hypertension. [2023]Retinal vessel dynamics analysis has proven to be a viable, non-invasive surrogate marker for increased intracranial pressure. We aimed to test this method in patients with suspected idiopathic intracranial hypertension.
A Review of the Methods of Non-Invasive Assessment of Intracranial Pressure through Ocular Measurement. [2022]The monitoring of intracranial pressure (ICP) is essential for the detection and treatment of most craniocerebral diseases. Invasive methods are the most accurate approach to measure ICP; however, these methods are prone to complications and have a limited range of applications. Therefore, non-invasive ICP measurement is preferable in a range of scenarios. The current non-invasive ICP measurement methods comprise fluid dynamics, and ophthalmic, otic, electrophysiological, and other methods. This article reviews eight methods of non-invasive estimation of ICP from ocular measurements, namely optic nerve sheath diameter, flash visual evoked potentials, two-depth transorbital Doppler ultrasonography, central retinal venous pressure, optical coherence tomography, pupillometry, intraocular pressure measurement, and retinal arteriole and venule diameter ratio. We evaluated and presented the indications and main advantages and disadvantages of these methods. Although these methods cannot completely replace invasive measurement, for some specific situations and patients, non-invasive measurement of ICP still has great potential.
A Noninvasive Method for Monitoring Intracranial Pressure During Postural Changes. [2021]Intracranial hypertension (IH) is an important cause of secondary brain injury, and its association with poor outcomes has been extensively demonstrated. Pathological intracranial hypertension is defined as a persistent rise in intracranial pressure (ICP) to above 20-25 mmHg, with symptoms such as headaches, loss of consciousness, seizures, and focal deficits, as well as ischemic damage. Therefore, monitoring of ICP is invaluable in the management of these symptoms. However, invasive measurements of ventricular pressure (requiring a surgical procedure) are considered the gold standard, thus limiting the practicality of ICP measurements. Vivonics, Inc., is developing a noninvasive optical device to assess ICP for use by emergency medical personnel, called IPASS: Intracranial Pressure Assessment and Screening System. IPASS uses four near-infrared sensors to measure hemodynamic oscillations at four different locations. Three sensors are used as reference signals and one sensor is used to detect cerebral blood volume oscillations. Pulse arrival delays between the measured cerebral blood volume oscillations and the blood volume oscillations measured at the three reference locations are calculated and correlated with estimated ICP changes, herein modulated by specific positional changes (in a head-down maneuver).