Clinical Value of Noninvasive Intracranial Pressure Measurement (Braincare)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Lithuanian University of Health Sciences
Sponsor:
Collaborator:
Kaunas University of Technology
Information provided by (Responsible Party):
Kestutis Petrikonis, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier:
NCT02130219
First received: March 20, 2014
Last updated: July 25, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Intracranial Hypertension
Device: Non-invasive intracranial pressure measurement
Device: Brain MRI/CT
Procedure: Lumbar puncture and cerebrospinal fluid pressure measurement
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Scientific Research and Development of Innovative Evidence Based Non-invasive Brain Diagnostic and Monitoring Solutions for Neurological and Traumatic Brain Injury Patients

Resource links provided by NLM:


Further study details as provided by Lithuanian University of Health Sciences:

Primary Outcome Measures:
  • 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. [ Time Frame: Simultaneous noninvasive ICP and CSF pressure measurements. All measurements will be collected within 20 months until 31 December 2014. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Device: 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.
Other Name: Non-invasive aICP meter Vittamed 205
Device: 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.

Procedure: 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 Name: CSF pressure measurement
Experimental: 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

Device: 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.
Other Name: Non-invasive aICP meter Vittamed 205
Device: 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.

Procedure: 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 Name: CSF pressure measurement
Experimental: 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

Device: 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.
Other Name: Non-invasive aICP meter Vittamed 205
Device: 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.

Experimental: 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

Device: 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.
Other Name: Non-invasive aICP meter Vittamed 205
Device: 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.

Procedure: 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 Name: CSF pressure measurement

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130219

Contacts
Contact: Kestutis Petrikonis, MD, PhD 00370326747 kestutispetrikonis@yahoo.com
Contact: Vaidas Matijosaitis, MD,PhD 00370326962 matijosa1@gmail.com

Locations
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno Klinikos Recruiting
Kaunas, Lithuania
Contact: Kestutis Petrikonis, MD,PhD       kestutispetrikonis@yahoo.com   
Principal Investigator: Kestutis Petrikonis, MD, PhD         
Sub-Investigator: Vaidas Matijosaitis, MD, PhD         
Sponsors and Collaborators
Lithuanian University of Health Sciences
Kaunas University of Technology
Investigators
Principal Investigator: Kestutis Petrikonis Lithuanian University of Health Sciences
  More Information

Publications:
Responsible Party: Kestutis Petrikonis, M.D., PhD, Associated professor, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT02130219     History of Changes
Other Study ID Numbers: CH-3-SMM-01/06, BE-2-26
Study First Received: March 20, 2014
Last Updated: July 25, 2014
Health Authority: Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Lithuanian University of Health Sciences:
ICP, intracranial hypertension, Vittamed 205

Additional relevant MeSH terms:
Hypertension
Intracranial Hypertension
Brain Injuries
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014