Clinical Trial: Clinical Value of Noninvasive Intracranial Pressure Measurement

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Lithuanian University of Health Sciences

Current Primary Outcome: 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. ]

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.


Original Primary Outcome: Number of participants with the results of noninvasive intracranial pressure measurement within clinically acceptable 4 mm Hg difference from CSF pressure. [ Time Frame: Simultaneous noninvasive ICP and CSF pressure measurements made within 15 minutes measurement interval. All measurements collected within 20 months until 31 December 2014. ]

CSF pressure in mmHg will be compared with noninvasive ICP measurements simultaneously during measurement procedures lasting around 15 minutes. 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 noninvasive ICP.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Lithuanian University of Health Sciences

Dates:
Date Received: March 20, 2014
Date Started: June 2013
Date Completion: December 2014
Last Updated: July 25, 2014
Last Verified: March 2014