NCT01909960

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

6.3 years

First QC Date

May 24, 2013

Last Update Submit

August 9, 2018

Conditions

Normal Pressure Hydrocephalus

Keywords

Normal pressure hydrocephalusFlow MRIDementiaCerebrospinal fluidShunt

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1 (baseline), Day 180

Secondary Outcomes (7)

  • Blood flow analysis : evolution other 6 months

    Day 1 (baseline), Day 180

  • Larson's score evolution over 6 months

    Day 1, Day 180

  • Neuropsychological test evolution over 6 months

    Day1, Day 180

  • Blood flow analysis : evolution other one year

    Day 1 (baseline) and Day 365

  • Larson's score evolution over one year

    Day 1 and Day 365

  • +2 more secondary outcomes

Study Arms (2)

Surgery

EXPERIMENTAL

Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)

Other: Flow imaging

Clinical follow-up

EXPERIMENTAL

Patients who will undergo flow imaging but not surgery (75% of the studied population)

Other: Flow imaging

Interventions

Flow imagingOTHER

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

Also known as: Flow MRI, Cine phase-constrast magnetic resonance imaging, CSF pulsatility, Hydrodynamic, Cerebral blood flow
Clinical follow-upSurgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ventricular dilation seen on morphological magnetic resonance imaging (MRI)
  • Walking disorder
  • Cognitive disorder
  • Participants gave their written informed consent

You may not qualify if:

  • Contra-indication to MRI
  • Obstructive tumoral hydrocephalus
  • Curatorship or tutorship
  • Pregnancy or lactation
  • No social assurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Lille

Lille, Hauts-de-France, 59000, France

Location

CHU Amiens

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Hydrocephalus, Normal PressureDementia

Interventions

HydrodynamicsCerebrovascular Circulation

Condition Hierarchy (Ancestors)

HydrocephalusBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical PhenomenaBlood CirculationCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Olivier Balédent, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2013

First Posted

July 29, 2013

Study Start

May 3, 2012

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

FR(2)