- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01909960
Flow MRI in Normal Pressure Hydrocephalus (HydroFlux)
Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nord Pas De Calais
-
Lille, Nord Pas De Calais, France, 59000
- CHU Lille
-
-
Picardie
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Amiens, Picardie, France, 80054
- CHU Amiens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ventricular dilation seen on morphological magnetic resonance imaging (MRI)
- Walking disorder
- Cognitive disorder
- Participants gave their written informed consent
Exclusion Criteria:
- Contra-indication to MRI
- Obstructive tumoral hydrocephalus
- Curatorship or tutorship
- Pregnancy or lactation
- No social assurance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgery
Patients who will undergo flow imaging and neurosurgery (shunting).
(25% of the studied population)
|
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
Other Names:
|
Experimental: Clinical follow-up
Patients who will undergo flow imaging but not surgery (75% of the studied population)
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1 (baseline), Day 180
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood flow analysis : evolution other 6 months
Time Frame: Day 1 (baseline), Day 180
|
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.
|
Day 1 (baseline), Day 180
|
Larson's score evolution over 6 months
Time Frame: Day 1, Day 180
|
Record symptoms on walking, living conditions and urinary disorders
|
Day 1, Day 180
|
Neuropsychological test evolution over 6 months
Time Frame: Day1, Day 180
|
Consists in mini mental status evaluation (MMSE) for cognitive evaluation
|
Day1, Day 180
|
Blood flow analysis : evolution other one year
Time Frame: Day 1 (baseline) and Day 365
|
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.
|
Day 1 (baseline) and Day 365
|
Larson's score evolution over one year
Time Frame: Day 1 and Day 365
|
Record symptoms on walking, living conditions and urinary disorders
|
Day 1 and Day 365
|
Neuropsychological test evolution over one year
Time Frame: Day1, Day 365
|
Consists in mini mental status evaluation (MMSE) for cognitive evaluation
|
Day1, Day 365
|
cerebrospinal fluid (CSF) stroke volume evolution other one year
Time Frame: Day1 (baseline), Day 365
|
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
|
Day1 (baseline), Day 365
|
Collaborators and Investigators
Investigators
- Principal Investigator: Olivier Balédent, PhD, CHU Amiens
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRCIR11-DR-BALEDENT
- 2011-A01633-38 (Registry Identifier: RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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