Clinical Value of Noninvasive Intracranial Pressure Measurement
Braincare
Scientific Research and Development of Innovative Evidence Based Non-invasive Brain Diagnostic and Monitoring Solutions for Neurological and Traumatic Brain Injury Patients
2 other identifiers
interventional
45
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
May 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJuly 28, 2014
March 1, 2014
1.5 years
March 20, 2014
July 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
Simultaneous noninvasive ICP and CSF pressure measurements. All measurements will be collected within 20 months until 31 December 2014.
Study Arms (4)
Chronic daily headache group
EXPERIMENTALPatients 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.
Multiple sclerosis group
EXPERIMENTALMultiple 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
Stroke group
EXPERIMENTALPatients 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
Normal pressure hydrocephalus group
EXPERIMENTALPatients 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
Interventions
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.
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 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.
Eligibility Criteria
You may qualify if:
- Chronic daily headache with suspected idiopathic intracranial hypertension
- Diagnosed of suspected multiple sclerosis (MS)
- Intracranial hemorrhage/ stroke
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, Lithuania
Related Publications (2)
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.
PMID: 24620972BACKGROUNDRagauskas 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.
PMID: 22573638BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kestutis Petrikonis
Lithuanian University of Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., PhD, Associated professor
Study Record Dates
First Submitted
March 20, 2014
First Posted
May 5, 2014
Study Start
June 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
July 28, 2014
Record last verified: 2014-03