Clinical Value of Noninvasive Intracranial Pressure Measurement (Braincare)

Lithuanian University of Health Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Intracranial Hypertension

Treatments: Device: Brain MRI/CT; Device: Non-invasive intracranial pressure measurement; Procedure: Lumbar puncture and cerebrospinal fluid pressure measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT02130219

CH-3-SMM-01/06

BE-2-26 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 4 patient groups

Chronic daily headache group

Experimental group

Description:

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.

Treatment:

Procedure: Lumbar puncture and cerebrospinal fluid pressure measurement

Device: Non-invasive intracranial pressure measurement

Device: Brain MRI/CT

Multiple sclerosis group

Experimental group

Description:

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

Treatment:

Procedure: Lumbar puncture and cerebrospinal fluid pressure measurement

Device: Non-invasive intracranial pressure measurement

Device: Brain MRI/CT

Stroke group

Experimental group

Description:

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

Treatment:

Device: Non-invasive intracranial pressure measurement

Device: Brain MRI/CT

Normal pressure hydrocephalus group

Experimental group

Description:

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

Treatment:

Procedure: Lumbar puncture and cerebrospinal fluid pressure measurement

Device: Non-invasive intracranial pressure measurement

Device: Brain MRI/CT