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
About this trial
This is an interventional other trial for Hydrocephalus
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.
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
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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