Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients

NCT04603118 | Completed

• 1 other identifier: DIA-SONSD
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic intracranial hypertensionis a type of increased intracranial pressure. Diagnosis is made by lumbar puncture, which is an invasive technique. The relationship between ICP and optic nerve sheath diameters (ONSD) were examined in our study. Thus, it was investigated whether the optic nerve sheath diameter could be used in the diagnosis of IIH. In the present study, it was found that ONSD measurement by optic USG significantly reflects increased ICP and decreasing pressure via LP is rapidly reflects to ONSD measurement. And it is suggested that ONSD measurements by optic USG, a non-invasive method, can be used in the diagnosis and follow-up of IIH patients.

Conditions

Pseudotumor Cerebri

Keywords

Idiopathic intracranial hypertension; Optic nerve sheath diameter measurement; Increased intracranial pressure; Lumbar puncture

Outcome Measures

Primary Outcomes (1)

• Correlation between intracranial pressure change and optic nerve sheath diameter

  Before and after lumbar puncture, optic nerve sheath diameter measured with optic ultrasonography. The correlation of these measurements with cerebrospinal fluid opening and closing pressures was investigated.

  Baseline to 10-15 minutes after lumbar puncture

Study Arms (2)

The patients with Idiopathic intracranial hypertension (IIH)

OTHER

33 patients who applied to the neurology clinic with the pre-diagnosis of IIH were performed lumbar puncture. 25 of them diagnosed with IIH. Optic nerve sheath diameter was measured by optic ultrasonography from both eyes before and after the LP.

Procedure: Optic ultrasonography; Procedure: Lumbar puncture

Control group

OTHER

In the control group, optic nerve sheath diameter was measured from both eyes by optic ultrasonography.

Procedure: Optic ultrasonography

Interventions

Optic ultrasonography PROCEDURE

Control group; The patients with Idiopathic intracranial hypertension (IIH)

Lumbar puncture PROCEDURE

The patients with Idiopathic intracranial hypertension (IIH)

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of idiopathic intracranial hypertension
• Adults aged 17-65

You may not qualify if:

• In cranial imaging, if pathology such as tumor, sinus vein thrombosis is detected
• People for whom lumbar puncture is contraindicated or cannot be performed

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ankara Numune Training and Research Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (29)

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MeSH Terms

Conditions

Pseudotumor Cerebri; Intracranial Hypertension

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Oğuzhan Kurşun

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Model Details: Patients who applied to the neurology clinics and were diagnosed with IIH were included in the study. The control group consisted of 22 individuals who applied with other complaints than headaches. ONSD was measured from both eyes before and after the LP. After pre-LP measurements were taken, opening and closing cerebrospinal fluid pressure was measured. In the control group, ONSD was measured with optic USG.

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 26, 2020
• Study Start: May 1, 2014
• Primary Completion: December 31, 2015
• Study Completion: April 1, 2016
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data is available for one year after publication
• Access Criteria: The reason and purpose of the request is clearly explained and the appropriate persons can access it via e-mail.

Locations

TU (1)