New Reference Values for Intracranial Pressure

NCT03594136 | Completed DMC

• 1 other identifier: P1NICP
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Intracranial Pressure

Keywords

Intracranial pressure; ICP; Normal value; Reference value; Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Normal Intracranial Pressure Values

  To determine reference values for intracranial pressure in healthy adults

  Each participants will be monitored for three months

Study Arms (1)

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

Device: Raumedic Neurovent-P-tel

Interventions

Raumedic Neurovent-P-tel DEVICE

Insertion of a Neurovent-P-tel in adults to study normal intracranial pressure

Telemetric intracranial pressure implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above the age of 18
• Requiring surgery for a "cold" (unruptured) aneurysm

You may not qualify if:

• Current or previous examination or treatment for hydrocephalus
• Current or previous examination or treatment for idiopathic intracranial hypertension
• Previous operation with insertion of cerebrospinal fluid shunt
• Previous trauma with intracranial hemorrhage
• Global cerebral edema
• Increased infection risks
• Surgical complications during the primary operation
• Unable to understand patient information

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Lundbeck Foundation: collaborator

Study Sites (3)

Military University Hospital Prague

Prague, 16902, Czechia

Location

Rigshospitalet

Copenhagen, Copenhagen E, 2100, Denmark

Location

Aarhus University Hospital

Aarhus, 8100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38773608 DERIVED

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Marianne Marianne, D.M.Sc.

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researh Assistant

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 20, 2018
• Study Start: February 1, 2018
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); DK (2)