Scientific Research and Development of Innovative Evidence Based Non-invasive Brain Diagnostic and Monitoring Solutions for Neurological and Traumatic Brain Injury Patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Intracranial Hypertension
- Sponsor
- Lithuanian University of Health Sciences
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- 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.
- Last Updated
- 11 years ago
Overview
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 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.
Investigators
Kestutis Petrikonis
M.D., PhD, Associated professor
Lithuanian University of Health Sciences
Eligibility 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
Outcomes
Primary Outcomes
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.