Clinical Value of Noninvasive Intracranial Pressure Measurement

Intracranial Hypertension Clinical Trial

— Braincare  

Official title:

Scientific Research and Development of Innovative Evidence Based Non-invasive Brain Diagnostic and Monitoring Solutions for Neurological and Traumatic Brain Injury Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02130219
• Other study ID #: CH-3-SMM-01/06
• Secondary ID: BE-2-26
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 20, 2014
• Last updated: July 25, 2014
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Lithuanian University of Health Sciences
• Contact: Kestutis Petrikonis, MD, PhD
• Phone: 00370326747
• Email: kestutispetrikonis[@]yahoo.com
• Is FDA regulated: No
• Health authority: Lithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intracranial Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno Klinikos	Kaunas

Sponsors (2)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Kaunas University of Technology

Country where clinical trial is conducted

Lithuania, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No