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Assessment of Cerebrospinal Fluid Flow Related Disorders Using a Phase-contrast Magnetic Resonance Imaging Technique.

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ClinicalTrials.gov Identifier: NCT03656016
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
Shimaa Hassanien Hassanien Bakr, Assiut University

Brief Summary:
Cerebrospinal fluid is a clear, colorless fluid that circulates in the cranial and spinal subarachnoid spaces, located between the pia and arachnoid matters. It is mainly produced by the choroid plexus, while lesser amount produced by the ependymal cells lining the ventricles. Its function includes cushioning and lubrication of the central nervous system, circulation of nutrients and waste collection providing basic mechanical and immunological protection to the brain.

Condition or disease Intervention/treatment
Cerebrospinal Fluid Device: Magnetic Resonance Imaging

Detailed Description:

There are several disorders such as communicating and non- communicating hydrocephalus, normal pressure hydrocephalus, cystic cerebrospinal fluid collections, Chiari malformation, syringomyelic cyst and arachnoid cyst that can change the cerebrospinal fluid dynamics.

Rapid advances in imaging techniques have remarkably improved the diagnosis and treatment of these disorders.

Phase contrast magnetic resonance imaging is a rapid, simple and non-invasive technique which is sensitive to even small cerebrospinal fluid flows, and can be used to evaluate cerebrospinal fluid flow both qualitatively and quantitatively. Cine phase contrast magnetic resonance images show cerebrospinal fluid flow in a dynamic, more easily appreciable, and in a more pleasing manner, allowing the delineation of obstruction, if present, along the portions of cerebrospinal fluid pathway where obstruction is common.

Phase contrast magnetic resonance imaging can be used to discriminate between communicating hydrocephalus and non-communicating hydrocephalus, to localize the level of obstruction in obstructive hydrocephalus, to determine whether arachnoid cysts communicate with the subarachnoid space, to differentiate between arachnoid cysts and subarachnoid space, to discriminate between syringomyelia and cystic myelomalacia, and to evaluate flow patterns of posterior fossa cystic malformations.

This imaging method can also provide significant information in pre-operative evaluation of Chiari 1 malformation and post-operative follow-up of patients with neuroendoscopic third ventriculostomy and ventriculoperitoneal shunt.

The application of cine phase contrast magnetic resonance imaging technique in patients with normal pressure hydrocephalus holds great promise for improvement of the diagnosis, especially in those cases where the differentiation from atrophy on clinical and conventional radiological basis is difficult.

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Study Type : Observational
Estimated Enrollment : 87 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment of Cerebrospinal Fluid Flow Related Disorders Using a Phase-contrast Magnetic Resonance Imaging Technique.
Actual Study Start Date : November 25, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
study group
patients with congenital and acquired disorders that can alter the CSF dynamics will undergo phase-contrast magnetic resonance imaging
Device: Magnetic Resonance Imaging
Phase contrast magnetic resonance imaging technique

control group
age matched healthy individuals will undergo phase-contrast magnetic resonance imaging
Device: Magnetic Resonance Imaging
Phase contrast magnetic resonance imaging technique




Primary Outcome Measures :
  1. To calculate different cerebrospinal fluid flow parameters at different levels of flow quantification. [ Time Frame: base line ]
    measure Systolic stroke volume and Peak systolic velocity at different levels of flow quantification


Secondary Outcome Measures :
  1. To correlate these parameters to the normal values of age matched control group [ Time Frame: baseline ]
    correlate Systolic stroke volume and Peak systolic velocity with normal values



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with different age groups and both sex with clinical and routine conventional magnetic resonance imaging findings suggestive of cerebrospinal fluid flow disorders
Criteria

Inclusion Criteria:

  • Patients with different age groups and both sex with clinical and routine conventional magnetic resonance imaging findings suggestive of cerebrospinal fluid flow disorders.

Exclusion Criteria:

  1. Patients with contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.
  2. Patients with VP shunts
  3. Patients with ventriculomegally due to brain SOLs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656016


Contacts
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Contact: Mostafa Hussein 01122999878 thabet.mostafa@yahoo.com
Contact: Hazem Youseif 01005075888 bozaidhazz@yahoo.com

Locations
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Egypt
Faculty of medicine Recruiting
Assiut, Egypt, 71111
Contact: Mostafa Thabet, MD    01122999878    thabet.mostafa@yahoo.com   
Contact: Marwa Ahmed, MD    01006541595    drmarwa201198@ymail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Shimaa Bakr, MSc Assiut University
Publications:
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Responsible Party: Shimaa Hassanien Hassanien Bakr, principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03656016    
Other Study ID Numbers: CSFFPCMRI
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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