Clinical trial NCT02130219: Clinical Value of Noninvasive Intracranial Pressure Measurement
Official title: Scientific Research and Development of Innovative Evidence Based Non-invasive Brain Diagnostic and Monitoring Solutions for Neurological and Traumatic Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Intracranial Hypertension
Keywords: ICP, intracranial hypertension, Vittamed 205
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Kaunas University of Technology
First posted: 2014-05-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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.
timeFrame: Simultaneous noninvasive ICP and CSF pressure measurements. All measurements will be collected within 20 months until 31 December 2014.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Kestutis Petrikonis
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.