Clinical Value of Noninvasive Intracranial Pressure Measurement

Phase 2

• Conditions: Intracranial Hypertension
• Interventions: Device: Non-invasive intracranial pressure measurement; Device: Brain MRI/CT; Procedure: Lumbar puncture and cerebrospinal fluid pressure measurement

• 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

Arm && Interventions

Group	Intervention	Description
Multiple sclerosis group	Brain MRI/CT	Multiple sclerosis (MS) group patients selected based on clinical symptoms and brain MRI changes typical for the disease. Diagnosis based on McDonalds criteria. CSF test for oligoclonal bands required as supporting diagnostic criteria. Patients selected with disease relapse symptoms. Simultaneous noninvasive ICP and CSF pressure measured. Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT
Chronic daily headache group	Lumbar puncture and cerebrospinal fluid pressure measurement	Patients with chronic daily headache with suspicion of intracranial hypertension selected. Selection based on clinical symptoms (headache description, leading symptoms)and para-clinical pathological findings (optical nerve papilla edema). Not enough evidence to diagnose any other headache type. Simultaneous CSF pressure measurements and non-invasive ICP measurement will be performed. Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT.
Stroke group	Brain MRI/CT	Patients selected for this group have stroke/intracranial hemorrhage that might be complicated with intracranial hypertension. Stroke/intracranial hemorrhage diagnosed based on clinical findings and changes on brain CT/MRI. Patients with stroke less than 33% of middle cerebral artery territory included. Patients with intracranial hemorrhage 20-40 ml volume included. Patients unable to cooperate or sign informed consent excluded. Bilateral non-invasive ICP measurements performed. Results compared with brain MRI/CT lesion volume, mid-line shift. Interventions: non-invasive intracranial pressure measurement; brain MRI/CT
Stroke group	Non-invasive intracranial pressure measurement	Patients selected for this group have stroke/intracranial hemorrhage that might be complicated with intracranial hypertension. Stroke/intracranial hemorrhage diagnosed based on clinical findings and changes on brain CT/MRI. Patients with stroke less than 33% of middle cerebral artery territory included. Patients with intracranial hemorrhage 20-40 ml volume included. Patients unable to cooperate or sign informed consent excluded. Bilateral non-invasive ICP measurements performed. Results compared with brain MRI/CT lesion volume, mid-line shift. Interventions: non-invasive intracranial pressure measurement; brain MRI/CT
Normal pressure hydrocephalus group	Brain MRI/CT	Patients meeting normal pressure hydrocephalus diagnosis criteria selected to compare invasive CSF pressure versus non-invasive ICP. Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT
Normal pressure hydrocephalus group	Lumbar puncture and cerebrospinal fluid pressure measurement	Patients meeting normal pressure hydrocephalus diagnosis criteria selected to compare invasive CSF pressure versus non-invasive ICP. Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT
Chronic daily headache group	Non-invasive intracranial pressure measurement	Patients with chronic daily headache with suspicion of intracranial hypertension selected. Selection based on clinical symptoms (headache description, leading symptoms)and para-clinical pathological findings (optical nerve papilla edema). Not enough evidence to diagnose any other headache type. Simultaneous CSF pressure measurements and non-invasive ICP measurement will be performed. Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT.
Chronic daily headache group	Brain MRI/CT	Patients with chronic daily headache with suspicion of intracranial hypertension selected. Selection based on clinical symptoms (headache description, leading symptoms)and para-clinical pathological findings (optical nerve papilla edema). Not enough evidence to diagnose any other headache type. Simultaneous CSF pressure measurements and non-invasive ICP measurement will be performed. Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT.
Multiple sclerosis group	Non-invasive intracranial pressure measurement	Multiple sclerosis (MS) group patients selected based on clinical symptoms and brain MRI changes typical for the disease. Diagnosis based on McDonalds criteria. CSF test for oligoclonal bands required as supporting diagnostic criteria. Patients selected with disease relapse symptoms. Simultaneous noninvasive ICP and CSF pressure measured. Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT
Multiple sclerosis group	Lumbar puncture and cerebrospinal fluid pressure measurement	Multiple sclerosis (MS) group patients selected based on clinical symptoms and brain MRI changes typical for the disease. Diagnosis based on McDonalds criteria. CSF test for oligoclonal bands required as supporting diagnostic criteria. Patients selected with disease relapse symptoms. Simultaneous noninvasive ICP and CSF pressure measured. Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT
Normal pressure hydrocephalus group	Non-invasive intracranial pressure measurement	Patients meeting normal pressure hydrocephalus diagnosis criteria selected to compare invasive CSF pressure versus non-invasive ICP. Interventions: non-invasive intracranial pressure measurement; lumbar puncture and cerebrospinal fluid pressure measurement; brain MRI/CT

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