NCT03656016

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 20, 2024

Status Verified

January 1, 2024

Enrollment Period

6.1 years

First QC Date

August 29, 2018

Last Update Submit

November 18, 2024

Conditions

Outcome Measures

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

    base line

Secondary Outcomes (1)

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

    baseline

Study Arms (2)

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

Phase contrast magnetic resonance imaging technique

control groupstudy group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Asyut, 71111, Egypt

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22100360BACKGROUND
  • 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.

    PMID: 16752134BACKGROUND
  • 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.

    PMID: 25012672BACKGROUND
  • 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.

    PMID: 11167329BACKGROUND
  • 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.

    PMID: 19816640BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Shimaa Bakr, MSc

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 4, 2018

Study Start

March 25, 2019

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

November 20, 2024

Record last verified: 2024-01

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