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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42476

Enrollment

Registered

2015-11-16

Start date

2016-01-23

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain pressure Intracranial pressure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Accuracy analysis: The main goal of the study is to validate the accuracy of HeadSenses non-invasive ICP monitor. In order to validate the accuracy of the HeadSenses device, a statistical comparison will be done between the ICP values from both the HeadSenses device and CSF pressure (during LP) using Pearsons correlation analysis of the paired measurements	—

Secondary

Measure	Time frame
None	—

Countries

Netherlands

Outcome results