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New Reference Values for Intracranial Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03594136
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Lundbeck Foundation
Information provided by (Responsible Party):
Nicolas Alexander Norager, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Intracranial Pressure Device: Raumedic Neurovent-P-tel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Challenging Reference Values for Intracranial Pressure: A Prospective, Multicenter, Clinical Study
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telemetric intracranial pressure implant
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
Insertion of a Neurovent-P-tel in adults to study normal intracranial pressure

Primary Outcome Measures :
  1. Normal Intracranial Pressure Values [ Time Frame: Each participants will be monitored for three months ]
    To determine reference values for intracranial pressure in healthy adults

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03594136

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Contact: Nicolas H Norager +4531713282
Contact: Marianne Juhler, D.M.Sc. 45 35 45 20 88

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Military University Hospital Prague Not yet recruiting
Prague, Czechia, 16902
Contact: Lea Novakova, Dr   
Rigshospitalet Recruiting
Copenhagen, Copenhagen E, Denmark, 2100
Contact: Nicolas H Norager    +45 31 71 32 82   
Contact: Marianne Juhler, D.M.Sc.    +45 35 45 20 88   
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8100
Contact: Nicolas H Norager    +45 31 71 32 82   
Sponsors and Collaborators
Rigshospitalet, Denmark
Lundbeck Foundation
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Study Director: Marianne Marianne, D.M.Sc. Rigshospitalet, Denmark

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Responsible Party: Nicolas Alexander Norager, Researh Assistant, Rigshospitalet, Denmark Identifier: NCT03594136     History of Changes
Other Study ID Numbers: P1NICP
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nicolas Alexander Norager, Rigshospitalet, Denmark:
Intracranial pressure
Normal value
Reference value