HydroFlux: Flow MRI in Normal Pressure Hydrocephalus

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01909960
• Collaborator: (none)
• Enrollment: 144
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 76
• Patients Per Site: 72
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.

Condition or Disease	Intervention/Treatment	Phase
Normal Pressure Hydrocephalus	Other: Flow imaging	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 144 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus
• Actual Study Start Date: May 3, 2012
• Anticipated Primary Completion Date: Sep 1, 2018
• Anticipated Study Completion Date: Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgery Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)	Other: Flow imaging; 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: Flow MRI Cine phase-constrast magnetic resonance imaging CSF pulsatility Hydrodynamic Cerebral blood flow
Experimental: Clinical follow-up Patients who will undergo flow imaging but not surgery (75% of the studied population)	Other: Flow imaging; 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: Flow MRI Cine phase-constrast magnetic resonance imaging CSF pulsatility Hydrodynamic Cerebral blood flow

Outcome Measures

Primary Outcome Measures

1. cerebrospinal fluid (CSF) stroke volume evolution other 6 months [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

Secondary Outcome Measures

1. Blood flow analysis : evolution other 6 months [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.

2. Larson's score evolution over 6 months [Day 1, Day 180]

   Record symptoms on walking, living conditions and urinary disorders

3. Neuropsychological test evolution over 6 months [Day1, Day 180]

   Consists in mini mental status evaluation (MMSE) for cognitive evaluation

4. Blood flow analysis : evolution other one year [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.

5. Larson's score evolution over one year [Day 1 and Day 365]

   Record symptoms on walking, living conditions and urinary disorders

6. Neuropsychological test evolution over one year [Day1, Day 365]

   Consists in mini mental status evaluation (MMSE) for cognitive evaluation

7. cerebrospinal fluid (CSF) stroke volume evolution other one year [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Lille	Lille	Nord Pas De Calais	France	59000
2	CHU Amiens	Amiens	Picardie	France	80054

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

• Principal Investigator: Olivier Balédent, PhD, CHU Amiens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT01909960
• Other Study ID Numbers: PHRCIR11-DR-BALEDENT; 2011-A01633-38
• First Posted: Jul 29, 2013
• Last Update Posted: Aug 10, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Centre Hospitalier Universitaire, Amiens: Normal pressure hydrocephalus; Flow MRI; Dementia; Cerebrospinal fluid; Shunt
• Additional relevant MeSH terms: Hydrocephalus; Hydrocephalus, Normal Pressure

Study Results

No Results Posted as of Aug 10, 2018