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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03656016
Other study ID # CSFFPCMRI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 25, 2018
Est. completion date December 2024

Study information

Verified date January 2024
Source Assiut University
Contact Mostafa Hussein
Phone 01122999878
Email thabet.mostafa@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 87
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Magnetic Resonance Imaging
Phase contrast magnetic resonance imaging technique

Locations

Country Name City State
Egypt Faculty of medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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