Intracranial PressureREVERTNCT05068128
Combined Flow and Pressure Study of Craniospinal Dynamic
An observational study of Intracranial Pressure and Cerebral Blood Flows, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Normal pressure hydrocephalus (NPH) can cause a type of dementia. However, this type of dementia is the only one that is reversible. To treat this dementia it is necessary to evacuate the accumulation of CSF from the brain to another body cavity using a device called a shunt. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Intracranial Pressure, Cerebral Blood Flows, Infusion Test
- What is being tested?
- Flow MRI and PERFUSION TEST
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2022to 24 Sep 2024
- Phase
- Observational
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected active hydrocephalus (HA) known as "normal pressure" and with Flow MRI and CSF infusion test.
Who may be able to join
- age > 55 years
- Patients with suspected active hydrocephalus (HA) known as "normal pressure":
- Ventricular dilatation: Evans index > 0.3
- Patients with cognitive impairment, and/or gait disorders and/or urinary incontinence or a combination of these three symptoms.
- Absence of other neurological diseases that could cause ventriculomegaly.
- Information and collection of the patient's non opposition
Who cannot join
- All patients with neurological disease other than active hydrocephalus will be excluded.
- Individuals who cannot tolerate an MRI examination
- All individuals with implants, pacemakers, prostheses and ferromagnetic objects
- Patients under guardianship, curators or safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Flow-pressure Study of Cerebrospinal Circulation Using CSF Perfusion Tests and Phase-contrast MRI - Reversible Dementia Substudy
Normal pressure hydrocephalus (NPH) can cause a type of dementia. However, this type of dementia is the only one that is reversible. To treat this dementia it is necessary to evacuate the accumulation of CSF from the brain to another body cavity using a device called a shunt. But the implantation of this shunt is only effective when the cause of the pathology is an alteration of the normal circulation of the CSF. To diagnose these patients, morphological MRI and lumbar puncture are standard approaches used but remain perfectible in diagnostic terms.
The main objective is to build a new model of the interaction of intracranial pressures and fluids in order to obtain a new parameter allowing to obtain information on the cerebral biomechanics.
- Conditions
- Intracranial Pressure, Cerebral Blood Flows, Infusion Test, Phase Contrast MRI, Hydrocephalus, Dementia
- Being tested
- Flow MRI, PERFUSION TEST
- Keywords
- Intracranial pressure, cerebral blood flows, infusion test, Phase contrast MRI, Hydrocephalus, Dementia
- Medical subject headings
- Hydrocephalus, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow MRIOther
4 flow acquisitions based on the 2D cine phase contrast sequence (present on all MRI systems) will be performed.
This sequence requires a cardiac synchronization by a plethysmograph put on the patient's finger.
32 cardiac phases are reconstructed per acquisition. The processing of the flow MRIs and the analysis of the flow curves of the LCS and blood during the cardiac cycle will be performed using the Amiens software.
Parameters measured via flow MRI are:
- Cerebral vascular flow, intracranial LCS dynamic volume, extracranial LCS dynamic volume
PERFUSION TESTOther
The test will be performed will include:
- Inserting a needle into the lumbar space, Ommaya reservoir or valve pre-chamber, as appropriate
- Connect the needle to the pressure transducer via saline filled manometer lines connected via a 3-way valve. The other end of the 3-way connection will be connected to a saline
- Recording of the opening pressure for 10 minutes
- The infusion test is terminated either when the pressure stabilizes again on a new plateau, or when the average pressure exceeds 40 mmHg, or in case of adverse effects or symptoms such as headache, nausea/vomiting or visual disturbances.
- At the end of the test, a depletion of 30 to 50 mL of CSF will be performed.
- The pressure recording during the test is then used to calculate the parameters of the mechanical properties of the CSF circulation and reported to the neurosurgeon ordering the test.
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of number of MRICP parameters according of CSF accumulation
The MRICP parameter will combine the CSF pressure and CSF flows. MRICP parameter results of the interaction of intracranial pressures and fluids in order allowing to obtain information on the cerebral biomechanics.
Accumulation of CSF from the brain to another body cavity is neccessary to be determined.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start4 Jan 2022
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Caen, University Hospital, Brest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068128
- Sponsor's protocol ID
- PI2021_843_0017
- Acronym
- REVERT
- Status last verified
- Jun 2026
- First submitted
- 7 Sep 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Flow-pressure Study of Cerebrospinal Circulation Using CSF Perfusion Tests and Phase-contrast MRI - Reversible Dementia Substudy
- ClinicalTrials.gov ID
- NCT05068128
- Acronym / sponsor ID
- REVERT / PI2021_843_0017
- Conditions
- Intracranial Pressure, Cerebral Blood Flows, Infusion Test, Phase Contrast MRI, Hydrocephalus, Dementia
- Keywords
- Intracranial pressure, cerebral blood flows, infusion test, Phase contrast MRI, Hydrocephalus, Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Caen, University Hospital, Brest
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 5 Oct 2021 (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.
Normal pressure hydrocephalus (NPH) can cause a type of dementia. However, this type of dementia is the only one that is reversible. To treat this dementia it is necessary to evacuate the accumulation of CSF from the brain to another body cavity using a device called a shunt. But the implantation of this shunt is only effective when the cause of the pathology is an alteration of the normal circulation of the CSF. To diagnose these patients, morphological MRI and lumbar puncture are standard approaches used but remain perfectible in diagnostic terms.
The main objective is to build a new model of the interaction of intracranial pressures and fluids in order to obtain a new parameter allowing to obtain information on the cerebral biomechanics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected active hydrocephalus (HA) known as "normal pressure" and with Flow MRI and CSF infusion test.
Key inclusion criteria (6 listed)
- age > 55 years
- Patients with suspected active hydrocephalus (HA) known as "normal pressure":
- Ventricular dilatation: Evans index > 0.3
- Patients with cognitive impairment, and/or gait disorders and/or urinary incontinence or a combination of these three symptoms.
- Absence of other neurological diseases that could cause ventriculomegaly.
Key exclusion criteria (4 listed)
- All patients with neurological disease other than active hydrocephalus will be excluded.
- Individuals who cannot tolerate an MRI examination
- All individuals with implants, pacemakers, prostheses and ferromagnetic objects
- Patients under guardianship, curators or safeguard of justice
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 |
|---|---|---|
| Flow MRI4 flow acquisitions based on the 2D cine phase contrast sequence (present on all MRI systems) will be performed. This sequence requires a cardiac synchronization by a plethysmograph put on the patient's finger. 32 cardiac phases are reconstructed per acquisition. The processing of the flow MRIs and the analysis of the flow curves of the LCS and blood during the cardiac cycle will be performed using the Amiens software. Parameters measured via flow MRI are: - Cerebral vascular flow, intracranial LCS dynamic volume, extracranial LCS dynamic volume | Other | – |
| PERFUSION TESTThe test will be performed will include: * Inserting a needle into the lumbar space, Ommaya reservoir or valve pre-chamber, as appropriate * Connect the needle to the pressure transducer via saline filled manometer lines connected via a 3-way valve. The other end of the 3-way connection will be connected to a saline * Recording of the opening pressure for 10 minutes * The infusion test is terminated either when the pressure stabilizes again on a new plateau, or when the average pressure exceeds 40 mmHg, or in case of adverse effects or symptoms such as headache, nausea/vomiting or visual disturbances. * At the end of the test, a depletion of 30 to 50 mL of CSF will be performed. * The pressure recording during the test is then used to calculate the parameters of the mechanical properties of the CSF circulation and reported to the neurosurgeon ordering the test. | Other | – |
Primary outcome
Variation of number of MRICP parameters according of CSF accumulation
Time frame: up to 3 years
The MRICP parameter will combine the CSF pressure and CSF flows. MRICP parameter results of the interaction of intracranial pressures and fluids in order allowing to obtain information on the cerebral biomechanics. Accumulation of CSF from the brain to another body cavity is neccessary to be determined.
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 12 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure and Cerebral Blood Flows, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 6 inclusion and 4 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Variation of number of MRICP parameters according of CSF accumulation (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.