New Reference Values for Intracranial Pressure

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Unknown status

CT.gov ID

NCT03594136

Collaborator

Lundbeck Foundation (Other)

Enrollment

Locations

Arm

26.9

Anticipated Duration (Months)

3.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

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 :

Feb 1, 2018

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Normal Intracranial Pressure Values [Each participants will be monitored for three months]
To determine reference values for intracranial pressure in healthy adults

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Military University Hospital Prague	Prague		Czechia	16902
2	Rigshospitalet	Copenhagen	Copenhagen E	Denmark	2100
3	Aarhus University Hospital	Aarhus		Denmark	8100

Sponsors and Collaborators

Rigshospitalet, Denmark
Lundbeck Foundation

Investigators

Study Director: Marianne Marianne, D.M.Sc., Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nicolas Alexander Norager, Researh Assistant, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT03594136

Other Study ID Numbers:

P1NICP

First Posted:

Jul 20, 2018

Last Update Posted:

Jul 20, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nicolas Alexander Norager, Researh Assistant, Rigshospitalet, Denmark

Intracranial pressure

Study Results

No Results Posted as of Jul 20, 2018