Clinical Value of Noninvasive Intracranial Pressure Measurement

Phase 2

• Conditions: Intracranial Hypertension

• Registration Number: NCT02130219
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Study Timeline

• Study Start: 2013-06
• Status Verified: 2014-03
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-05
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-28
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Hospital of Lithuanian University of Health Sciences Kauno Klinikos; 🇱🇹 Kaunas, Lithuania