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Pseudotumor CerebriNCT04603118

Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients

A study testing Optic ultrasonography and Lumbar puncture in people with Pseudotumor Cerebri, run by Ege University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Pseudotumor Cerebri
What is being tested?
Optic ultrasonography and Lumbar puncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2014to 1 Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara Numune Training and Research Hospital

    Ankara, 06230

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Optic Nerve Sheath Diameters Measured by Optic Ultrasonography Before and After Lumbar Puncture in Idiopathic Intracranial Hypertension Patients

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.

Read the detailed description

Backgrounds: Idiopathic intracranial hypertension (IIH); symptoms include headaches, blurred vision and papilledema which may lead to permanent visual loss. Definitive diagnosis of IIH usually requires the measurement of intracranial pressure (ICP) via lumbar puncture (LP) which is an invasive technique. In our study, the relationship between ICP and optic nerve sheath diameters (ONSD) were examined. Thus it was investigated whether optic nerve ultrasonography (USG) is a useful tool instead of LP for the diagnosis of IIH.

Methods: A total of 25 patients who applied to the neurology clinics of Ankara Numune Training and Research Hospital between May 2014 and December 2015 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 CSF (cerebrospinal fluid) pressure was measured. In the control group, ONSD was measured with optic USG.

Being tested
Optic ultrasonography, Lumbar puncture
Keywords
Idiopathic intracranial hypertension, Optic nerve sheath diameter measurement, Increased intracranial pressure, Lumbar puncture
Medical subject headings
Pseudotumor Cerebri, Intracranial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optic ultrasonographyProcedure or surgery

  • Lumbar punctureProcedure or surgery

Study groups in NCT04603118
Study groupRoleWhat they receive
The patients with Idiopathic intracranial hypertension (IIH)Other33 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.
Receives: Procedure: Optic ultrasonography; Procedure: Lumbar puncture
Control groupOtherIn the control group, optic nerve sheath diameter was measured from both eyes by optic ultrasonography.
Receives: Procedure: Optic ultrasonography

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 10-15 minutes after lumbar puncture

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start1 May 2014
  3. Primary completion31 Dec 2015
  4. Study completion1 Apr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04603118
Sponsor's protocol ID
DIA-SONSD
Status last verified
Oct 2020
First submitted
3 Oct 2020
Last updated
26 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For a reasonable purpose, data can be given to appropriate people if desired.

Publications

  • Soler D, Cox T, Bullock P, Calver DM, Robinson RO. Diagnosis and management of benign intracranial hypertension. Arch Dis Child. 1998 Jan;78(1):89-94. doi: 10.1136/adc.78.1.89. No abstract available.

    PubMed 9534686

  • Sorensen PS, Krogsaa B, Gjerris F. Clinical course and prognosis of pseudotumor cerebri. A prospective study of 24 patients. Acta Neurol Scand. 1988 Feb;77(2):164-72. doi: 10.1111/j.1600-0404.1988.tb05888.x.

    PubMed 3364156

  • Wall M, George D. Idiopathic intracranial hypertension. A prospective study of 50 patients. Brain. 1991 Feb;114 ( Pt 1A):155-80.

    PubMed 1998880

  • Giuseffi V, Wall M, Siegel PZ, Rojas PB. Symptoms and disease associations in idiopathic intracranial hypertension (pseudotumor cerebri): a case-control study. Neurology. 1991 Feb;41(2 ( Pt 1)):239-44. doi: 10.1212/wnl.41.2_part_1.239.

    PubMed 1992368

  • Durcan FJ, Corbett JJ, Wall M. The incidence of pseudotumor cerebri. Population studies in Iowa and Louisiana. Arch Neurol. 1988 Aug;45(8):875-7. doi: 10.1001/archneur.1988.00520320065016.

    PubMed 3395261

  • Dhungana S, Sharrack B, Woodroofe N. Idiopathic intracranial hypertension. Acta Neurol Scand. 2010 Feb;121(2):71-82. doi: 10.1111/j.1600-0404.2009.01172.x. Epub 2009 Nov 23.

    PubMed 19930211

  • Radhakrishnan K, Ahlskog JE, Garrity JA, Kurland LT. Idiopathic intracranial hypertension. Mayo Clin Proc. 1994 Feb;69(2):169-80. doi: 10.1016/s0025-6196(12)61045-3.

    PubMed 8309269

  • Degnan AJ, Levy LM. Pseudotumor cerebri: brief review of clinical syndrome and imaging findings. AJNR Am J Neuroradiol. 2011 Dec;32(11):1986-93. doi: 10.3174/ajnr.A2404. Epub 2011 Jun 16.

    PubMed 21680652

  • Brazis PW. Clinical review: the surgical treatment of idiopathic pseudotumour cerebri (idiopathic intracranial hypertension). Cephalalgia. 2008 Dec;28(12):1361-73. doi: 10.1111/j.1468-2982.2008.01778.x.

    PubMed 19037972

  • Levine DN. Ventricular size in pseudotumor cerebri and the theory of impaired CSF absorption. J Neurol Sci. 2000 Aug 15;177(2):85-94. doi: 10.1016/s0022-510x(00)00348-8.

    PubMed 10980304

  • Bruce BB, Kedar S, Van Stavern GP, Monaghan D, Acierno MD, Braswell RA, Preechawat P, Corbett JJ, Newman NJ, Biousse V. Idiopathic intracranial hypertension in men. Neurology. 2009 Jan 27;72(4):304-9. doi: 10.1212/01.wnl.0000333254.84120.f5. Epub 2008 Oct 15.

    PubMed 18923135

  • Avery RA, Shah SS, Licht DJ, Seiden JA, Huh JW, Boswinkel J, Ruppe MD, Chew A, Mistry RD, Liu GT. Reference range for cerebrospinal fluid opening pressure in children. N Engl J Med. 2010 Aug 26;363(9):891-3. doi: 10.1056/NEJMc1004957. No abstract available.

    PubMed 20818852

  • Hayreh SS. Pathogenesis of optic disc edema in raised intracranial pressure. Prog Retin Eye Res. 2016 Jan;50:108-44. doi: 10.1016/j.preteyeres.2015.10.001.

    PubMed 26453995

  • Hayreh SS. Optic disc edema in raised intracranial pressure. V. Pathogenesis. Arch Ophthalmol. 1977 Sep;95(9):1553-65. doi: 10.1001/archopht.1977.04450090075006.

    PubMed 71138

  • Suzuki H, Takanashi J, Kobayashi K, Nagasawa K, Tashima K, Kohno Y. MR imaging of idiopathic intracranial hypertension. AJNR Am J Neuroradiol. 2001 Jan;22(1):196-9.

    PubMed 11158909

Questions about this trial

What is this clinical trial studying?

A study testing Optic ultrasonography and Lumbar puncture in people with Pseudotumor Cerebri, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between intracranial pressure change and optic nerve sheath diameter (time frame: Baseline to 10-15 minutes after lumbar puncture). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04603118, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.

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