Comparison of the non-invasive intracranial pressure Headsense monitor vs lumbar cerebrospinal fluid pressure measurements

Completed

• Conditions: brain pressure; Intracranial pressure; 10021666

• Registration Number: NL-OMON42476
• Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

-Male or Female in the age range of 18 years and older
-All patients who are referred for elective lumbar puncture including CSF pressure measurement

Exclusion Criteria

-Local infection in the ear
-Pregnant or lactating women
-Cervical spine stenose
-Arnold-Chiari malformations
-Aquaductal stenosis or other changes causing an uneven CSF pressure between different compartments
-Mass lesions
-Current or previous craniotomy or craniectomies
-Suspection of meningitis or encephalitis

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Accuracy analysis: The main goal of the study is to validate the accuracy of<br /><br>HeadSense*s non-invasive ICP monitor. In order to validate the accuracy of the<br /><br>HeadSense*s device, a statistical comparison will be done between the ICP<br /><br>values from both the HeadSense*s device and CSF pressure (during LP) using<br /><br>Pearson*s correlation analysis of the paired measurements</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>None</p><br>