Normal Pressure HydrocephalusEarly Phase 1NCT01815775
Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery
A Early Phase 1 study testing clinical and imaging examinations in people with Normal Pressure Hydrocephalus, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- clinical and imaging examinations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2006to Jul 2009
- Phase
- Early Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: over 20 years
- diagnostic of normal pressure hydrocephalus
- ventricular dilation visible on radiological examination
- patients gave their written informed consent
Who cannot join
- age: less than 20 years
- MRI contra-indication
- pregnancy
- lumbar puncture within 48 hours before MRI
- cardiac arrhythmia
- cerebral/lacunar stroke
Trial locations and contacts
1 site in 1 country.
About this study
The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery. The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of predictive value of surgery response.
In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and 4th ventricle levels.
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- clinical and imaging examinations
- 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.
clinical and imaging examinationsOther
Also called flow MRI, cine phase-constrast magnetic resonance imaging, CSF pulsatility, hydrodynamic
Quantitative CSF 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 flow was measured with a velocity-encoding value of 10-20 cm/s. 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 neuropsychological assessment (including mini mental state examination test and Bradley's scale) as well as Hakim's triad evaluation
| Study group | Role | What they receive |
|---|---|---|
| Normal pressure hydrocephalus | Experimental | Hydrocephalus patients planned for shunting surgery. They will undergo clinical and imaging examinations at day 1, 3 months and 1 year after their surgery. Receives: Other: clinical and imaging examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF stroke volume
Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level
Measured: Day 1
Secondary outcomes (8)
Hakim's triad evaluation
Assessment of the signs of normal pressure hydrocephalus
Measured: Day 1
Hakim's triad evaluation
Assessment of the signs of normal pressure hydrocephalus (follow-up)
Measured: Day 90
Hakim's triad evaluation
Assessment of the signs of normal pressure hydrocephalus (follow-up)
Measured: Day 365
Neuropsychological test
classical neuropsychological assessment (including mini mental status evaluation)
Measured: Day 1
Neuropsychological test
classical neuropsychological assessment (including mini mental status evaluation) (follow up)
Measured: Day 90
Neuropsychological test
classical neuropsychological assessment (including mini mental status evaluation) (follow up)
Measured: Day 365
CSF stroke volume
Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)
Measured: Day 60
CSF stroke volume
Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMar 2006
- Primary completionJul 2008
- Study completionJul 2009
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 Normal Pressure HydrocephalusStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815775
- Sponsor's protocol ID
- PI05-PR-LEGARS
- Other IDs
- 2006/0023
- Status last verified
- Sep 2025
- First submitted
- 19 Mar 2013
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.
PubMed 20097391
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery
- ClinicalTrials.gov ID
- NCT01815775
- Acronym / sponsor ID
- PI05-PR-LEGARS
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- Normal pressure hydrocephalus, flow MRI, dementia, cerebrospinal fluid, shunt
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Mar 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.
The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery. The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of predictive value of surgery response.
In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and 4th ventricle levels.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal pressure hydrocephalus | Experimental | Other: clinical and imaging examinationsHydrocephalus patients planned for shunting surgery. They will undergo clinical and imaging examinations at day 1, 3 months and 1 year after their surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age: over 20 years
- diagnostic of normal pressure hydrocephalus
- ventricular dilation visible on radiological examination
- patients gave their written informed consent
Key exclusion criteria (6 listed)
- age: less than 20 years
- MRI contra-indication
- pregnancy
- lumbar puncture within 48 hours before MRI
- cardiac arrhythmia
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 |
|---|---|---|
| clinical and imaging examinationsAlso: flow MRI, cine phase-constrast magnetic resonance imaging, CSF pulsatility, hydrodynamicQuantitative CSF 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 flow was measured with a velocity-encoding value of 10-20 cm/s. 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 neuropsychological assessment (including mini mental state examination test and Bradley's scale) as well as Hakim's triad evaluation | Other | Normal pressure hydrocephalus |
Primary outcome
CSF stroke volume
Time frame: Day 1
Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level
8 secondary outcomes
Hakim's triad evaluation
Time frame: Day 1
Hakim's triad evaluation
Time frame: Day 90
Hakim's triad evaluation
Time frame: Day 365
Neuropsychological test
Time frame: Day 1
Neuropsychological test
Time frame: Day 90
Neuropsychological test
Time frame: Day 365
CSF stroke volume
Time frame: Day 60
CSF stroke volume
Time frame: 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 19 Sep 2025.
- Results publication: PubMed 20097391Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.
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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?
A Early Phase 1 study testing clinical and imaging examinations in people with Normal Pressure Hydrocephalus, 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 4 inclusion and 6 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 19 Sep 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
CSF stroke volume (time frame: Day 1). 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 NCT01815775, 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 19 Sep 2025.