Clinical Value of Noninvasive Intracranial Pressure Measurement
NCT ID: NCT02130219
Last Updated: 2014-07-28
Study Results
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Basic Information
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UNKNOWN
PHASE2/PHASE3
45 participants
INTERVENTIONAL
2013-06-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Chronic daily headache group
Patients with chronic daily headache with suspicion of intracranial hypertension selected. Selection based on clinical symptoms (headache description, leading symptoms)and para-clinical pathological findings (optical nerve papilla edema). Not enough evidence to diagnose any other headache type. Simultaneous CSF pressure measurements and non-invasive ICP measurement will be performed.
Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT.
Non-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.
Brain 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.
Lumbar 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.
Multiple sclerosis group
Multiple sclerosis (MS) group patients selected based on clinical symptoms and brain MRI changes typical for the disease. Diagnosis based on McDonalds criteria. CSF test for oligoclonal bands required as supporting diagnostic criteria. Patients selected with disease relapse symptoms. Simultaneous noninvasive ICP and CSF pressure measured.
Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT
Non-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.
Brain 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.
Lumbar 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.
Stroke group
Patients selected for this group have stroke/intracranial hemorrhage that might be complicated with intracranial hypertension. Stroke/intracranial hemorrhage diagnosed based on clinical findings and changes on brain CT/MRI. Patients with stroke less than 33% of middle cerebral artery territory included. Patients with intracranial hemorrhage 20-40 ml volume included. Patients unable to cooperate or sign informed consent excluded.
Bilateral non-invasive ICP measurements performed. Results compared with brain MRI/CT lesion volume, mid-line shift.
Interventions: non-invasive intracranial pressure measurement; brain MRI/CT
Non-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.
Brain 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.
Normal pressure hydrocephalus group
Patients meeting normal pressure hydrocephalus diagnosis criteria selected to compare invasive CSF pressure versus non-invasive ICP.
Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT
Non-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.
Brain 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.
Lumbar 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.
Interventions
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Non-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.
Brain 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.
Lumbar 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed of suspected multiple sclerosis (MS)
* Intracranial hemorrhage/ stroke
Exclusion Criteria
* Uncooperative patient
* Intracranial hemorrhage volume \<20 or \>40ml
* Stroke area larger than 1/3 of the middle cerebral artery
18 Years
80 Years
ALL
No
Sponsors
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Kaunas University of Technology
OTHER
Lithuanian University of Health Sciences
OTHER
Responsible Party
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Kestutis Petrikonis
M.D., PhD, Associated professor
Principal Investigators
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Kestutis Petrikonis
Role: PRINCIPAL_INVESTIGATOR
Lithuanian University of Health Sciences
Locations
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Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, , Lithuania
Countries
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Central Contacts
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Facility Contacts
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References
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Ragauskas A, Bartusis L, Piper I, Zakelis R, Matijosaitis V, Petrikonis K, Rastenyte D. Improved diagnostic value of a TCD-based non-invasive ICP measurement method compared with the sonographic ONSD method for detecting elevated intracranial pressure. Neurol Res. 2014 Jul;36(7):607-14. doi: 10.1179/1743132813Y.0000000308. Epub 2014 Jan 12.
Ragauskas A, Matijosaitis V, Zakelis R, Petrikonis K, Rastenyte D, Piper I, Daubaris G. Clinical assessment of noninvasive intracranial pressure absolute value measurement method. Neurology. 2012 May 22;78(21):1684-91. doi: 10.1212/WNL.0b013e3182574f50. Epub 2012 May 9.
Other Identifiers
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BE-2-26
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CH-3-SMM-01/06
Identifier Type: -
Identifier Source: org_study_id
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