NCT04060810

Brief Summary

To evaluate accuracy of (MRI) cerebrospinal fluid flowmetry after shunt operation in patients with borderline (grey zone) hydrocephalus.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

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

Study Start

First participant enrolled

August 1, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

August 13, 2019

Last Update Submit

August 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Decompressive changes in CT brain

    CT brain showing decompression of the ventricular system in response to ventriculoperitoneal shunt

    2 months

Study Arms (1)

grey zone hydrocephalic patients

OTHER

MR CSF flowmetry CT brain Ventriculoperitoneal shunt

Other: MR CSF flowmetry

Interventions

MR flowmetry in grey zone hydro cephalic patients followed by ventriculoperitoneal shunt

Also known as: CT brain, Ventriculoperitoneal shunt
grey zone hydrocephalic patients

Eligibility Criteria

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

You may qualify if:

  • Patients with borderline hydrocephalus
  • Clinically:suspicious and non specific symptoms as
  • Headache
  • Macrocranium
  • Vomiting
  • Gait instability
  • Dementia
  • Urine incontinence.
  • delayed milestone.
  • Radiologicaly: dilated ventricular system.

You may not qualify if:

  • Documented or clinically and radiologically evident cases of hydrocephalus
  • Patients known to have contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Brassow F, Baumann K. Volume of brain ventricles in man determined by computer tomography. Neuroradiology. 1978;16:187-9. doi: 10.1007/BF00395246.

    PMID: 310977BACKGROUND
  • Algin O, Hakyemez B, Parlak M. Phase-contrast MRI and 3D-CISS versus contrast-enhanced MR cisternography on the evaluation of the aqueductal stenosis. Neuroradiology. 2010 Feb;52(2):99-108. doi: 10.1007/s00234-009-0592-x. Epub 2009 Sep 15.

    PMID: 19756563BACKGROUND
  • Venkataramana NK. Hydrocephalus Indian scenario - A review. J Pediatr Neurosci. 2011 Oct;6(Suppl 1):S11-22. doi: 10.4103/1817-1745.85704.

    PMID: 22069421BACKGROUND
  • Bhatnagar V, George J, Mitra DK, Upadhyaya P. Complications of cerebrospinal fluid shunts. Indian J Pediatr. 1983 Mar-Apr;50(403):133-8. doi: 10.1007/BF02821431. No abstract available.

    PMID: 6618572BACKGROUND
  • Reddy GK, Bollam P, Caldito G. Long-term outcomes of ventriculoperitoneal shunt surgery in patients with hydrocephalus. World Neurosurg. 2014 Feb;81(2):404-10. doi: 10.1016/j.wneu.2013.01.096. Epub 2013 Feb 4.

    PMID: 23380280BACKGROUND

MeSH Terms

Conditions

Hydrocephalus

Interventions

Ventriculoperitoneal Shunt

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid ShuntsAnastomosis, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Mohammad Taghyan

    professor

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at neurosurgery department

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 19, 2019

Study Start

August 1, 2019

Primary Completion

August 1, 2020

Study Completion

March 1, 2021

Last Updated

August 19, 2019

Record last verified: 2019-08