Intracranial PressureNCT03594136
New Reference Values for Intracranial Pressure
A study testing Raumedic Neurovent-P-tel in people with Intracranial Pressure, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Pressure
- What is being tested?
- Raumedic Neurovent-P-tel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Feb 2018to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above the age of 18
- Requiring surgery for a "cold" (unruptured) aneurysm
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Denmark2 sites
Aarhus University Hospital
Aarhus, 8100
Rigshospitalet
Copenhagen, Copenhagen E, 2100
About this study
Official title: Challenging Reference Values for Intracranial Pressure: A Prospective, Multicenter, Clinical Study
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
- Being tested
- Raumedic Neurovent-P-tel
- Keywords
- Intracranial pressure, ICP, Normal value, Reference value, Hydrocephalus
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raumedic Neurovent-P-telDevice
Insertion of a Neurovent-P-tel in adults to study normal intracranial pressure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Raumedic Neurovent-P-tel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal Intracranial Pressure Values
To determine reference values for intracranial pressure in healthy adults
Measured: Each participants will be monitored for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Feb 2018
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Nicolas Alexander Norager, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Marianne Marianne, D.M.Sc., Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594136
- Sponsor's protocol ID
- P1NICP
- Status last verified
- Jan 2024
- First submitted
- 11 Jul 2018
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38773608
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenging Reference Values for Intracranial Pressure: A Prospective, Multicenter, Clinical Study
- ClinicalTrials.gov ID
- NCT03594136
- Acronym / sponsor ID
- P1NICP
- Conditions
- Intracranial Pressure
- Keywords
- Intracranial pressure, ICP, Normal value, Reference value, Hydrocephalus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemetric intracranial pressure implant | Experimental | Device: Raumedic Neurovent-P-telA telemetric intracranial pressure monitoring sensor is inserted into the brain parenchyma at the end of an uncomplicated surgery for an unruptured aneurysm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above the age of 18
- Requiring surgery for a "cold" (unruptured) aneurysm
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raumedic Neurovent-P-telInsertion of a Neurovent-P-tel in adults to study normal intracranial pressure | Device | Telemetric intracranial pressure implant |
Primary outcome
Normal Intracranial Pressure Values
Time frame: Each participants will be monitored for three months
To determine reference values for intracranial pressure in healthy adults
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 38773608Norager 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Marianne, D.M.Sc. study director
Copenhagen University Hospital, Rigshospitalet
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raumedic Neurovent-P-tel in people with Intracranial Pressure, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal Intracranial Pressure Values (time frame: Each participants will be monitored for three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.