HydrocephalusNCT04060810
Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients
A study testing MR CSF flowmetry in people with Hydrocephalus, run by Assiut University.
Trial summary
To evaluate accuracy of (MRI) cerebrospinal fluid flowmetry after shunt operation in patients with borderline (grey zone) hydrocephalus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- MR CSF flowmetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with borderline hydrocephalus
- Clinically:suspicious and non specific symptoms as
- Headache
- Macrocranium
- Vomiting
- Gait instability
Show all 10Show fewer
- Dementia
- Urine incontinence.
- delayed milestone.
- Radiologicaly: dilated ventricular system.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate accuracy of (MRI) cerebrospinal fluid flowmetry after shunt operation in patients with borderline (grey zone) hydrocephalus.
Read the 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.
- Conditions
- Hydrocephalus
- Being tested
- MR CSF flowmetry
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR CSF flowmetryOther
Also called CT brain, Ventriculoperitoneal shunt
MR flowmetry in grey zone hydro cephalic patients followed by ventriculoperitoneal shunt
| Study group | Role | What they receive |
|---|---|---|
| grey zone hydrocephalic patients | Other | MR CSF flowmetry CT brain Ventriculoperitoneal shunt Receives: Other: MR CSF flowmetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decompressive changes in CT brain
CT brain showing decompression of the ventricular system in response to ventriculoperitoneal shunt
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study startAug 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Hossam Mohammad Hassan, Assiut University
- Investigators
- Mohammad Taghyan, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060810
- Sponsor's protocol ID
- grey zone hydrocephalus
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brassow F, Baumann K. Volume of brain ventricles in man determined by computer tomography. Neuroradiology. 1978;16:187-9. doi: 10.1007/BF00395246.
PubMed 310977Algin 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.
PubMed 19756563Venkataramana NK. Hydrocephalus Indian scenario - A review. J Pediatr Neurosci. 2011 Oct;6(Suppl 1):S11-22. doi: 10.4103/1817-1745.85704.
PubMed 22069421Bhatnagar 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.
PubMed 6618572Reddy 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.
PubMed 23380280
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients
- ClinicalTrials.gov ID
- NCT04060810
- Acronym / sponsor ID
- grey zone hydrocephalus
- Conditions
- Hydrocephalus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| grey zone hydrocephalic patients | Other | Other: MR CSF flowmetryMR CSF flowmetry CT brain Ventriculoperitoneal shunt |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with borderline hydrocephalus
- Clinically:suspicious and non specific symptoms as
- Radiologicaly: dilated ventricular system.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR CSF flowmetryAlso: CT brain, Ventriculoperitoneal shuntMR flowmetry in grey zone hydro cephalic patients followed by ventriculoperitoneal shunt | Other | grey zone hydrocephalic patients |
Primary outcome
Decompressive changes in CT brain
Time frame: 2 months
CT brain showing decompression of the ventricular system in response to ventriculoperitoneal shunt
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Background: PubMed 310977Brassow F, Baumann K. Volume of brain ventricles in man determined by computer tomography. Neuroradiology. 1978;16:187-9. doi: 10.1007/BF00395246.
- Background: PubMed 19756563Algin 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.
- Background: PubMed 22069421Venkataramana NK. Hydrocephalus Indian scenario - A review. J Pediatr Neurosci. 2011 Oct;6(Suppl 1):S11-22. doi: 10.4103/1817-1745.85704.
- Background: PubMed 6618572Bhatnagar 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.
- Background: PubMed 23380280Reddy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Taghyan study chair
professor
Questions about this trial
What is this clinical trial studying?
A study testing MR CSF flowmetry in people with Hydrocephalus, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Mohammad (01005663647, mohamed011353@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decompressive changes in CT brain (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04060810, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.