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| Name | Class |
|---|---|
| Lundbeck Foundation | OTHER |
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Intracranial pressure is a cornerstone in neurosurgical care used in a variety of diseases. However currently, doubts regarding normal intracranial pressure exist. Few studies have investigated normal intracranial pressure in truly normal adults. The aim of this study is to investigate intracranial pressure in adults who have normal intracranial pressure physiology.
In this prospective, multicenter, clinical study, the intracranial pressure of 10 adults requiring surgery for an unruptured aneurysm will be investigated. These patients are thought to be normal in terms of intracranial pressure physiology. At the end of their surgery for an aneurysm, a telemetric intracranial pressure monitoring sensor will be implanted. Afterward, intracranial pressure curves will be obtained non-invasively 1., 14., 30 and 90 days after implantation. The intracranial pressure will be investigated in 5 different positions (supine, lumbar, upright sitting, standing and walking). Furthermore, a 24-hour measurement will be performed in their home environment, thus investigating intracranial pressure under daily activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemetric intracranial pressure implant | Experimental | A telemetric intracranial pressure monitoring sensor is inserted into the brain parenchyma at the end of an uncomplicated surgery for an unruptured aneurysm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raumedic Neurovent-P-tel | Device | Insertion of a Neurovent-P-tel in adults to study normal intracranial pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normal Intracranial Pressure Values | To determine reference values for intracranial pressure in healthy adults | Each participants will be monitored for three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Marianne, D.M.Sc. | Rigshospitalet, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military University Hospital Prague | Prague | 16902 | Czechia | |||
| Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38773608 | Derived | Norager NH, Lilja-Cyron A, Riedel CS, Holst AV, Pedersen SH, Juhler M. Intracranial pressure following surgery of an unruptured intracranial aneurysm-a model for normal intracranial pressure in humans. Fluids Barriers CNS. 2024 May 21;21(1):44. doi: 10.1186/s12987-024-00549-1. |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Copenhagen |
| Copenhagen E |
| 2100 |
| Denmark |
| Aarhus University Hospital | Aarhus | 8100 | Denmark |