NCT05647837

Brief Summary

Aim of the study is to high lighten the rule of CSF biomarkers in early diagnosis of IIH and in follow up to reach to a definite clinically based decision if this patient will improved on medical treatment or that patient is in need for surgical intervention.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

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

Study Start

First participant enrolled

December 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

December 13, 2022

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

October 22, 2022

Last Update Submit

November 30, 2022

Conditions

Intracranial Hypertension

Keywords

biomarkers

Outcome Measures

Primary Outcomes (2)

  • Relation between lumper puncture opening pressure and specific biomarkers

    Lumper puncture and measurement of CSF opening pressure (above 20 mm water). Measurement tools: Enzyme-linked immunosorbent assay (ELISA) test for amount of specific biomarkers both in CSF and serum. Specific Biomarkers: 1. Neurofilament light chain(NLC) 2. Hypoxia induced factor(HIF)

    Baseline

  • Relation between lumper puncture opening pressure and visual disturbance

    Clinical and visual assessment and CSF opening pressure measurement. measurement tools: Ophthalmoscope Measuring grades of papilledema using the Frisén scale

    3 days

Study Arms (1)

patients wit IIH

EXPERIMENTAL

patient that complains of symptoms of chronic increase intracranial pressure especially visual with absent of organic cause through visual assessment, routine laboratory investigation and brain imaging. these patients will undergo lumper puncture to assess CSF opening pressure and Neurofilament Light Chain (NFL) and HYpoxia Induced Factor (HIF) both in CSF and blood.

Diagnostic Test: lumper puncture

Interventions

lumper punctureDIAGNOSTIC_TEST

lumper puncture

patients wit IIH

Eligibility Criteria

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

You may qualify if:

  • \- 1. All patients with signs and symptoms of increased intracranial pressure (headaches, nausea, vomiting, transient visual obscurations, papilledema).
  • \. CSF opening pressure \>25 cm water with normal CSF composition.

You may not qualify if:

  • \. localizing neurologic signs, except for unilateral or bilateral sixth cranial nerve palsy.
  • \. Evidence of hydrocephalus, mass, infection, structural, or vascular lesion (including venous sinus thrombosis) on imaging.
  • \. Patients with IIH who undergo surgical intervention (thecoperitoneal shunt or optic nerve fenestration) 4. Other identified causes of increased ICP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

Related Publications (2)

  • Kalyvas A, Neromyliotis E, Koutsarnakis C, Komaitis S, Drosos E, Skandalakis GP, Pantazi M, Gobin YP, Stranjalis G, Patsalides A. A systematic review of surgical treatments of idiopathic intracranial hypertension (IIH). Neurosurg Rev. 2021 Apr;44(2):773-792. doi: 10.1007/s10143-020-01288-1. Epub 2020 Apr 25.

    PMID: 32335853BACKGROUND

  • Sinclair AJ, Ball AK, Burdon MA, Clarke CE, Stewart PM, Curnow SJ, Rauz S. Exploring the pathogenesis of IIH: an inflammatory perspective. J Neuroimmunol. 2008 Sep 15;201-202:212-20. doi: 10.1016/j.jneuroim.2008.06.029. Epub 2008 Aug 3.

    PMID: 18676028BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mahmoud H Ragab, professor

    professor

    STUDY CHAIR

  • Abdelhakeem A Essa, Ass. prof.

    Assistant professor

    STUDY DIRECTOR

Central Study Contacts

Ebrahim A Yousuf, master

CONTACT

01118550865Ebrahim.20133765@med.au.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

October 22, 2022

First Posted

December 13, 2022

Study Start

December 1, 2021

Primary Completion

November 20, 2022

Study Completion

March 1, 2023

Last Updated

December 13, 2022

Record last verified: 2022-11

Locations

EG(1)