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

• ClinicalTrials.gov Identifier: NCT03656016
• Recruitment Status: Recruiting
• First Posted: September 4, 2018
• Last Update Posted: June 29, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Shimaa Hassanien Hassanien Bakr, Assiut University

Study Description

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.

Study Design

• 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: February 2022
• Estimated Study Completion Date: June 2022

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Mostafa Hussein; 01122999878; thabet.mostafa@yahoo.com

Contact: Hazem Youseif; 01005075888; bozaidhazz@yahoo.com

Locations

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

• Principal Investigator: Shimaa Bakr, MSc; Assiut University

More Information

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. Review.

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. 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. Review.

Parkkola RK, Komu ME, Aärimaa 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.

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. Review.

• Responsible Party: Shimaa Hassanien Hassanien Bakr, principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03656016
• Other Study ID Numbers: CSFFPCMRI
• First Posted: September 4, 2018
• Last Update Posted: June 29, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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