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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04060810
Collaborator
(none)
10
1
19

Study Details

Study Description

Brief Summary

To evaluate accuracy of (MRI) cerebrospinal fluid flowmetry after shunt operation in patients with borderline (grey zone) hydrocephalus.

Condition or Disease Intervention/Treatment Phase
  • Other: MR CSF flowmetry
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients
Anticipated Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: grey zone hydrocephalic patients

MR CSF flowmetry CT brain Ventriculoperitoneal shunt

Other: MR CSF flowmetry
MR flowmetry in grey zone hydro cephalic patients followed by ventriculoperitoneal shunt
Other Names:
  • CT brain
  • Ventriculoperitoneal shunt
  • Outcome Measures

    Primary Outcome Measures

    1. Decompressive changes in CT brain [2 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Mohammad Taghyan, professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohammad Hossam Mohammad Hassan, Resident at neurosurgery department, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04060810
    Other Study ID Numbers:
    • grey zone hydrocephalus
    First Posted:
    Aug 19, 2019
    Last Update Posted:
    Aug 19, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2019