NCT06353412

Brief Summary

Aim of the study :

  1. 1.to determine the response to each treatment plan.
  2. 2.to determine when to choose specific treatment method.
  3. 3.to determine complication of each type of treatment method

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
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

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

March 20, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2026

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

March 20, 2024

Last Update Submit

April 2, 2024

Conditions

IIH - Idiopathic Intracranial Hypertension

Outcome Measures

Primary Outcomes (3)

  • Patient improvement regarding headache, visual symptoms

    Determine the Severity of headache on scale from (0-10) ((0-4)\>mild, (5-7)\>moderate, (8-10)\>sever)

    1 year

  • Patients improvement regarding fundus examination during regular visual assessment

    Fundus examination grading (1-2-3-4)

    1 year

  • Complication

    Complication of each treatment option

    1 year

Secondary Outcomes (1)

  • Other

    1 year

Interventions

Lumbar puncturePROCEDURE

Medical treatment Lumbar puncture Theco peritoneal shunt

Also known as: Theco peritoneal shunt

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients have symptoms of increased intracranial hypertension presenting to Assiut University hospital

You may qualify if:

  • patient has symptoms of increased intracranial pressure with :-
  • papilledema,
  • normal neurological examination,(except 6th nerve palsy),
  • elevated opening pressure( \>=25 cm) csf,
  • normal csf content

You may not qualify if:

  • Any patient diagnosed with increased intracranial pressure due to:
  • sinus thrombosis or stenosis will be excluded from this study and .accordingly endovascular stenting as a method of treatment will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Bubshait RF, Almomen AA. The Endonasal Endoscopic Management of Cerebrospinal Fluid Rhinorrhea. Cureus. 2021 Feb 20;13(2):e13457. doi: 10.7759/cureus.13457.

    PMID: 33777546BACKGROUND

  • Mollan SP, Aguiar M, Evison F, Frew E, Sinclair AJ. The expanding burden of idiopathic intracranial hypertension. Eye (Lond). 2019 Mar;33(3):478-485. doi: 10.1038/s41433-018-0238-5. Epub 2018 Oct 24.

    PMID: 30356129BACKGROUND

  • Friedman DI, Liu GT, Digre KB. Revised diagnostic criteria for the pseudotumor cerebri syndrome in adults and children. Neurology. 2013 Sep 24;81(13):1159-65. doi: 10.1212/WNL.0b013e3182a55f17. Epub 2013 Aug 21.

    PMID: 23966248BACKGROUND

  • Markey KA, Mollan SP, Jensen RH, Sinclair AJ. Understanding idiopathic intracranial hypertension: mechanisms, management, and future directions. Lancet Neurol. 2016 Jan;15(1):78-91. doi: 10.1016/S1474-4422(15)00298-7. Epub 2015 Dec 8.

    PMID: 26700907BACKGROUND

  • Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

    PMID: 29368949BACKGROUND

  • Akhter A, Schulz L, Inger HE, McGregor JM. Current Indications for Management Options in Pseudotumor Cerebri. Neurol Clin. 2022 May;40(2):391-404. doi: 10.1016/j.ncl.2021.11.011. Epub 2022 Mar 31.

    PMID: 35465882BACKGROUND

MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Intracranial HypertensionBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Radwan Elnouby, Professor

    Assiut University

    STUDY CHAIR

  • Wael M Ali, AssProfessor

    Assiut University

    STUDY DIRECTOR

  • Mohamed A Ragaee, AssProfessor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mohamed AM Mansour, Master

CONTACT

01060685379Mohamed.15235787@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 20, 2024

First Posted

April 9, 2024

Study Start

June 1, 2024

Primary Completion

September 1, 2025

Study Completion

March 9, 2026

Last Updated

April 9, 2024

Record last verified: 2024-04