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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebrospinal Fluid
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Estimated): 87

Contacts and Locations

• Study Contact: Name: Mostafa Hussein; Phone Number: 01122999878; Email: thabet.mostafa@yahoo.com
• Study Contact Backup: Name: Hazem Youseif; Phone Number: 01005075888; Email: bozaidhazz@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Recruiting
    • Faculty of medicine
    • Contact: Mostafa Thabet, MD; Phone Number: 01122999878; Email: thabet.mostafa@yahoo.com
    • Contact: Marwa Ahmed, MD; Phone Number: 01006541595; Email: drmarwa201198@ymail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To calculate different cerebrospinal fluid flow parameters at different levels of flow quantification.	measure Systolic stroke volume and Peak systolic velocity at different levels of flow quantification	base line

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To correlate these parameters to the normal values of age matched control group	correlate Systolic stroke volume and Peak systolic velocity with normal values	baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Shimaa Bakr, MSc, Assiut University

Publications and helpful links

General Publications

• Sakka L, Coll G, Chazal J. Anatomy and physiology of cerebrospinal fluid. Eur Ann Otorhinolaryngol Head Neck Dis. 2011 Dec;128(6):309-16. doi: 10.1016/j.anorl.2011.03.002. Epub 2011 Nov 18.
• Yildiz H, Yazici Z, Hakyemez B, Erdogan C, Parlak M. Evaluation of CSF flow patterns of posterior fossa cystic malformations using CSF flow MR imaging. Neuroradiology. 2006 Sep;48(9):595-605. doi: 10.1007/s00234-006-0098-8. Epub 2006 Jun 3.
• Yamada S, Tsuchiya K, Bradley WG, Law M, Winkler ML, Borzage MT, Miyazaki M, Kelly EJ, McComb JG. Current and emerging MR imaging techniques for the diagnosis and management of CSF flow disorders: a review of phase-contrast and time-spatial labeling inversion pulse. AJNR Am J Neuroradiol. 2015 Apr;36(4):623-30. doi: 10.3174/ajnr.A4030. Epub 2014 Jul 10.
• Parkkola RK, Komu ME, Aarimaa TM, Alanen MS, Thomsen C. Cerebrospinal fluid flow in children with normal and dilated ventricles studied by MR imaging. Acta Radiol. 2001 Jan;42(1):33-8. doi: 10.1080/028418501127346431.
• Ng SE, Low AM, Tang KK, Lim WE, Kwok RK. Idiopathic normal pressure hydrocephalus: correlating magnetic resonance imaging biomarkers with clinical response. Ann Acad Med Singap. 2009 Sep;38(9):803-8.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CSFFPCMRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No