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Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients

Primary Purpose

Hydrocephalus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MR CSF flowmetry
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hydrocephalus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with borderline hydrocephalus

  • Clinically:suspicious and non specific symptoms as

    • Headache
    • Macrocranium
    • Vomiting
    • Gait instability
    • Dementia
    • Urine incontinence.
    • delayed milestone.
  • Radiologicaly: dilated ventricular system.

Exclusion Criteria:

  • Documented or clinically and radiologically evident cases of hydrocephalus
  • Patients known to have contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    grey zone hydrocephalic patients

    Arm Description

    MR CSF flowmetry CT brain Ventriculoperitoneal shunt

    Outcomes

    Primary Outcome Measures

    Decompressive changes in CT brain
    CT brain showing decompression of the ventricular system in response to ventriculoperitoneal shunt

    Secondary Outcome Measures

    Full Information

    First Posted
    August 13, 2019
    Last Updated
    August 16, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04060810
    Brief Title
    Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients
    Official Title
    Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2019 (Anticipated)
    Primary Completion Date
    August 2020 (Anticipated)
    Study Completion Date
    March 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate accuracy of (MRI) cerebrospinal fluid flowmetry after shunt operation in patients with borderline (grey zone) hydrocephalus.
    Detailed Description
    Hydrocephalus could be defined as disturbance of formation, flow or absorption of CSF. We encounter some challenging cases with intermittent non specific symptoms as delayed milestones and headache with concomitant imaging showing dilated ventricular system, so we find ourselves hesitating to take the decision of surgical intervention to put shunt or not, therefore MRI CSF flowmetry gives us a chance to overcome this problem. Phase contrast MR imaging is a rapid, simple and non-invasive technique which is sensitive to even small CSF flows, and can be used to evaluate CSF flow both qualitatively and quantitatively. CSF flow measurement at the suspected level of obstruction gives reliable and reproducible results for more accurate diagnosis and can be used to guide therapeutic decisions in a more reliable manner, and follow up post treatment outcome. With the CT and magnetic resonance imaging (MRI) techniques, it is possible to localize with accuracy the exact site of blockage of flow to CSF. Hence classification is as follows: The hydrocephalus may be due to 1) overproduction of CSF 2) obstructive 3) absorption defect. Depending on the exact aetiology, a secondary classification could be added under the following headings: 1) congenital, 2) acquired, eg; traumatic inflammatory, neoplastic, and degenerative . Bypassing the site of obstruction to CSF flow by diverting the CSF from ventricular cavity to a site where it is readily absorbed is the basic principle underlying the treatment of hydrocephalus. Extensive range of complications has been reported for shunting for hydrocephalus. They could be classified as mechanical or flow-related complications as CSF over drainage leading to subdural hematoma, subdural collections, low-pressure headaches cranial deformity, and asymmetrical drainage can lead to trapping or isolation of a part of a ventricular system. The slit ventricular syndrome is a complication related to absorption. Besides, ascites, loculations, hydrocele, perforation of the stomach, large and small bowel are also described. The success rates of shunt operation for hydrocephalus depend on the age of the patient and the reason why the shunt is needed. Generally, there is around a 50% failure rate for ventriculoperitoneal shunts.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hydrocephalus

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    grey zone hydrocephalic patients
    Arm Type
    Other
    Arm Description
    MR CSF flowmetry CT brain Ventriculoperitoneal shunt
    Intervention Type
    Other
    Intervention Name(s)
    MR CSF flowmetry
    Other Intervention Name(s)
    CT brain, Ventriculoperitoneal shunt
    Intervention Description
    MR flowmetry in grey zone hydro cephalic patients followed by ventriculoperitoneal shunt
    Primary Outcome Measure Information:
    Title
    Decompressive changes in CT brain
    Description
    CT brain showing decompression of the ventricular system in response to ventriculoperitoneal shunt
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with borderline hydrocephalus Clinically:suspicious and non specific symptoms as Headache Macrocranium Vomiting Gait instability Dementia Urine incontinence. delayed milestone. Radiologicaly: dilated ventricular system. Exclusion Criteria: Documented or clinically and radiologically evident cases of hydrocephalus Patients known to have contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammad Mohammad
    Phone
    01005663647
    Email
    mohamed011353@med.aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad Taghyan
    Organizational Affiliation
    professor
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    310977
    Citation
    Brassow F, Baumann K. Volume of brain ventricles in man determined by computer tomography. Neuroradiology. 1978;16:187-9. doi: 10.1007/BF00395246.
    Results Reference
    background
    PubMed Identifier
    19756563
    Citation
    Algin O, Hakyemez B, Parlak M. Phase-contrast MRI and 3D-CISS versus contrast-enhanced MR cisternography on the evaluation of the aqueductal stenosis. Neuroradiology. 2010 Feb;52(2):99-108. doi: 10.1007/s00234-009-0592-x. Epub 2009 Sep 15.
    Results Reference
    background
    PubMed Identifier
    22069421
    Citation
    Venkataramana NK. Hydrocephalus Indian scenario - A review. J Pediatr Neurosci. 2011 Oct;6(Suppl 1):S11-22. doi: 10.4103/1817-1745.85704.
    Results Reference
    background
    PubMed Identifier
    6618572
    Citation
    Bhatnagar V, George J, Mitra DK, Upadhyaya P. Complications of cerebrospinal fluid shunts. Indian J Pediatr. 1983 Mar-Apr;50(403):133-8. doi: 10.1007/BF02821431. No abstract available.
    Results Reference
    background
    PubMed Identifier
    23380280
    Citation
    Reddy GK, Bollam P, Caldito G. Long-term outcomes of ventriculoperitoneal shunt surgery in patients with hydrocephalus. World Neurosurg. 2014 Feb;81(2):404-10. doi: 10.1016/j.wneu.2013.01.096. Epub 2013 Feb 4.
    Results Reference
    background

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    Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients

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