Intracranial Hypertension
Conditions
Keywords
ICP, intracranial hypertension, Vittamed 205
Brief summary
The aim of the study is to evaluate accuracy and precision of non-invasive intracranial pressure measurement device (Vittamed 205) for selected patients compared with cerebrospinal fluid pressure measured during lumbar puncture
Detailed description
Non-invasive intracranial pressure (ICP) measurements with Vittamed 205 aICP meter will be compared to simultaneous cerebrospinal fluid (CSF) pressure measurements during lumbar puncture. Measures of pressure in mmHg will be compared. These measurements will be compared in chronic daily headache, normal pressure hydrocephalus and multiple sclerosis patients groups. For stroke patients noninvasive measurements will be compared with cerebral lesion in brain MRI/CT.
Interventions
DEVICENon-invasive intracranial pressure measurement
The noninvasive ICP measurement device Vittamed 205 aICP meter used in this study has been developed in Lithuania. The method is based on two-depth transcranial Doppler technique for simultaneously measuring flow velocity pulsatilities in the intracranial and extracranial segments of the ophthalmic artery (OA). These measurements are made while applying a series of small pressure steps to the tissues surrounding the eye-ball. The intracranial segment of the OA is compressed by ICP and the extracranial segment of the OA is compressed by the externally applied pressure Pe. Blood flow pulsatility parameters in both of these OA segments are monitored.Pulsatilities are approximately the same when Pe = ICP. Two-depth TCD device is used as an indicator of the pressure balance point.
DEVICEBrain MRI/CT
1.5 T MRI using T1 and T2 regimes, brain MRI angiography, performed for selected patients to analyze anatomical features of ophthalmic artery and optical nerves sheath diameter. Brain CT performed to evaluate hemorrhage and stroke volume.
PROCEDURELumbar puncture and cerebrospinal fluid pressure measurement
Lumbar puncture performed in lateral decubitus position while knees and head flexed. After local antiseptics and anesthesia puncture in lumbar 3/4 or 4/5 intervertebral space performed. As CSF appears legs and head are relaxed and slightly straightened. Spinal manometer graded 0-40 cm H₂O with stopcock connected to the needle. CSF pressure monitored for 10 minutes and recorded. CSF collected for diagnostic test. Spinal needle Number 22 and Rocket Spinal Manometer Set (No. R55990) used for this study.
Sponsors
Kaunas University of Technology
Lithuanian University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chronic daily headache with suspected idiopathic intracranial hypertension * Diagnosed of suspected multiple sclerosis (MS) * Intracranial hemorrhage/ stroke
Exclusion criteria
* Patient not able to understand information about the trial * Uncooperative patient * Intracranial hemorrhage volume \<20 or \>40ml * Stroke area larger than 1/3 of the middle cerebral artery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with the results of noninvasive intracranial pressure measurement (with Vittamed 205 aICP meter) within clinically acceptable 4 mm Hg difference from invasively measured CSF pressure. | Simultaneous noninvasive ICP and CSF pressure measurements. All measurements will be collected within 20 months until 31 December 2014. | Brain MRI/CT data will be used to compare ocular nerve sheath diameter (in mm) and stroke/ intracerebral hemorrhage volume (in cubic cm) with CSF pressure and non-invasive ICP. |
Countries
Lithuania
Contacts
Primary ContactKestutis Petrikonis, MD, PhD
Backup ContactVaidas Matijosaitis, MD,PhD
Outcome results
None listed