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RecruitingNCT03656016Updated Nov 20, 2024

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

An observational study in Cerebrospinal Fluid, sponsored by Assiut University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Mar 2019; still recruiting 7 years 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
87
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebrospinal Fluid
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
87 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • control group

    age matched healthy individuals will undergo phase-contrast magnetic resonance imaging

    Device: Magnetic Resonance Imaging

Interventions

  • DeviceMagnetic Resonance Imaging

    Phase contrast magnetic resonance imaging technique

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: base line

Secondary outcomes

  1. To correlate these parameters to the normal values of age matched control group

    correlate Systolic stroke volume and Peak systolic velocity with normal values

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
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References and documents

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. PubMed 22100360 ↗
  • 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. PubMed 16752134 ↗
  • 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. PubMed 25012672 ↗
  • 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. PubMed 11167329 ↗
  • 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. PubMed 19816640 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03656016
Lead sponsor
Assiut University
Responsible party
Shimaa Hassanien Hassanien Bakr (principal Investigator, Assiut University) — Principal investigator
First posted
Sep 4, 2018
Start date
Mar 25, 2019
Primary completion
May 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Nov 20, 2024

Study contacts

Mostafa Hussein
Contact
thabet.mostafa@yahoo.com
01122999878
Hazem Youseif
Contact
bozaidhazz@yahoo.com
01005075888
Shimaa Bakr, MSc
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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