Normal Pressure HydrocephalusHydroFluxNCT01909960
Flow MRI in Normal Pressure Hydrocephalus
A study testing Flow imaging in people with Normal Pressure Hydrocephalus, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- Flow imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesFrance
- Study dates
- 3 May 2012to 18 Aug 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ventricular dilation seen on morphological magnetic resonance imaging (MRI)
- Walking disorder
- Cognitive disorder
- Participants gave their written informed consent
Who cannot join
- Contra-indication to MRI
- Obstructive tumoral hydrocephalus
- Curatorship or tutorship
- Pregnancy or lactation
- No social assurance
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Amiens
Amiens, Picardie, 80054
CHU Lille
Lille, Hauts-de-France, 59000
About this study
Official title: Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus
Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- Flow imaging
- Keywords
- Normal pressure hydrocephalus, Flow MRI, Dementia, Cerebrospinal fluid, Shunt
- Medical subject headings
- Hydrocephalus, Normal Pressure, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow imagingOther
Also called Flow MRI, Cine phase-constrast magnetic resonance imaging, CSF pulsatility, Hydrodynamic
Quantitative flow study was performed by 2D phase-contrast velocity-encoded cine MRI (repetition/echo time, 15/7 ms; field of view = 140 x 140 mm²; matrix size = 256 x 128, flip angle = 25 degrees,one excitation, slice thickness = 5 mm). Cerebrospinal fluid and blood flows are measured with a velocity-encoding value of 5-10 cm/s and 80 cm/s respectively. Peripheral gating was used to cover the entire cardiac cycle with retrospective cardiac synchronization of 32 quantitative flow-encoded images per cycle.
Clinical examination consists in Larson's score and MMSE
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population) Receives: Other: Flow imaging |
| Clinical follow-up | Experimental | Patients who will undergo flow imaging but not surgery (75% of the studied population) Receives: Other: Flow imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebrospinal fluid (CSF) stroke volume evolution other 6 months
Measurement of cerebrospinal fluid (CSF) stroke volume via flow MRI at the Sylvius' aqueduct, pontine cistern and spinal spaces levels and determination of its evolution
Measured: Day 1 (baseline), Day 180
Secondary outcomes (7)
Blood flow analysis : evolution other 6 months
Assessment of arterial (internal carotids and cerebral arteries) and venous (sagittal sinus, straight sinus) blood flow in terms of mean cerebral blood outflow and stroke volume and determination of blood flow evolution.
Measured: Day 1 (baseline), Day 180
Larson's score evolution over 6 months
Record symptoms on walking, living conditions and urinary disorders
Measured: Day 1, Day 180
Neuropsychological test evolution over 6 months
Consists in mini mental status evaluation (MMSE) for cognitive evaluation
Measured: Day1, Day 180
Blood flow analysis : evolution other one year
Assessment of arterial (internal carotids and cerebral arteries) and venous (sagittal sinus, straight sinus) blood flow in terms of mean cerebral blood outflow and stroke volume and determination of blood flow evolution.
Measured: Day 1 (baseline) and Day 365
Larson's score evolution over one year
Record symptoms on walking, living conditions and urinary disorders
Measured: Day 1 and Day 365
Neuropsychological test evolution over one year
Consists in mini mental status evaluation (MMSE) for cognitive evaluation
Measured: Day1, Day 365
cerebrospinal fluid (CSF) stroke volume evolution other one year
Measurement of cerebrospinal fluid (CSF) stroke volume via flow MRI at the Sylvius' aqueduct, pontine cistern and spinal spaces levels and determination of its evolution
Measured: Day1 (baseline), Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study start3 May 2012
- Primary completion18 Aug 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Balédent, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909960
- Sponsor's protocol ID
- PHRCIR11-DR-BALEDENT
- Other IDs
- 2011-A01633-38
- Acronym
- HydroFlux
- Status last verified
- Jun 2026
- First submitted
- 24 May 2013
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT01909960
- Acronym / sponsor ID
- HydroFlux / PHRCIR11-DR-BALEDENT
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- Normal pressure hydrocephalus, Flow MRI, Dementia, Cerebrospinal fluid, Shunt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 3 May 2012 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 29 Jul 2013 (estimated)
- 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 diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Other: Flow imagingPatients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population) |
| Clinical follow-up | Experimental | Other: Flow imagingPatients who will undergo flow imaging but not surgery (75% of the studied population) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ventricular dilation seen on morphological magnetic resonance imaging (MRI)
- Walking disorder
- Cognitive disorder
- Participants gave their written informed consent
Key exclusion criteria (5 listed)
- Contra-indication to MRI
- Obstructive tumoral hydrocephalus
- Curatorship or tutorship
- Pregnancy or lactation
- No social assurance
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 imagingAlso: Flow MRI, Cine phase-constrast magnetic resonance imaging, CSF pulsatility, HydrodynamicQuantitative flow study was performed by 2D phase-contrast velocity-encoded cine MRI (repetition/echo time, 15/7 ms; field of view = 140 x 140 mm²; matrix size = 256 x 128, flip angle = 25 degrees,one excitation, slice thickness = 5 mm). Cerebrospinal fluid and blood flows are measured with a velocity-encoding value of 5-10 cm/s and 80 cm/s respectively. Peripheral gating was used to cover the entire cardiac cycle with retrospective cardiac synchronization of 32 quantitative flow-encoded images per cycle. Clinical examination consists in Larson's score and MMSE | Other | Clinical follow-up, Surgery |
Primary outcome
cerebrospinal fluid (CSF) stroke volume evolution other 6 months
Time frame: Day 1 (baseline), Day 180
Measurement of cerebrospinal fluid (CSF) stroke volume via flow MRI at the Sylvius' aqueduct, pontine cistern and spinal spaces levels and determination of its evolution
7 secondary outcomes
Blood flow analysis : evolution other 6 months
Time frame: Day 1 (baseline), Day 180
Larson's score evolution over 6 months
Time frame: Day 1, Day 180
Neuropsychological test evolution over 6 months
Time frame: Day1, Day 180
Blood flow analysis : evolution other one year
Time frame: Day 1 (baseline) and Day 365
Larson's score evolution over one year
Time frame: Day 1 and Day 365
Neuropsychological test evolution over one year
Time frame: Day1, Day 365
cerebrospinal fluid (CSF) stroke volume evolution other one year
Time frame: Day1 (baseline), Day 365
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 11 Jun 2026.
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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.
Olivier Balédent, PhD principal investigator
CHU Amiens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow imaging in people with Normal Pressure Hydrocephalus, run by Centre Hospitalier Universitaire, Amiens at 2 sites 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 4 inclusion and 5 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 11 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 2 sites 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?
cerebrospinal fluid (CSF) stroke volume evolution other 6 months (time frame: Day 1 (baseline), Day 180). 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 11 Jun 2026.