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

August 16, 2019 updated by: Mohammad Hossam Mohammad Hassan, Assiut University
To evaluate accuracy of (MRI) cerebrospinal fluid flowmetry after shunt operation in patients with borderline (grey zone) hydrocephalus.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decompressive changes in CT brain
Time Frame: 2 months
CT brain showing decompression of the ventricular system in response to ventriculoperitoneal shunt
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mohammad Taghyan, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2019

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 16, 2019

First Posted (ACTUAL)

August 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2019

Last Update Submitted That Met QC Criteria

August 16, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • grey zone hydrocephalus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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