Intracranial HypertensionNCT05647837
CSF Biomarkers in Idiopathic Intracranial Hypertension
A study testing lumper puncture in people with Intracranial Hypertension, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- lumper puncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to Mar 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1. All patients with signs and symptoms of increased intracranial pressure (headaches, nausea, vomiting, transient visual obscurations, papilledema).
- 2. CSF opening pressure >25 cm water with normal CSF composition.
Who cannot join
- 1. localizing neurologic signs, except for unilateral or bilateral sixth cranial nerve palsy.
- 2. Evidence of hydrocephalus, mass, infection, structural, or vascular lesion (including venous sinus thrombosis) on imaging.
- 3. Patients with IIH who undergo surgical intervention (thecoperitoneal shunt or optic nerve fenestration) 4. Other identified causes of increased ICP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value of Cerebrospinal Fluid (CSF) Biomarkers in Patients of Idiopathic Intracranial Hypertension (IIH) as an Indicative of Visual Affection and Treatment Modalities
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.
Read the detailed description
Idiopathic intracranial hypertension (IIH) is a rare disease of increasing incidence recently[1], owing to the rising curve of obesity and weight gain[2,3]. It is a disease of elevated intracranial pressure without known obvious aetiology. The reported incidence of IIH is 1 to 3 cases per 100,000 people of the general population[4]. IIH is diagnosed by exclusion; as patients come with continuous headache repeated vomiting , pulsatile tinnitus and the hall landmark of this disease, visual disturbance. One of the most deleterious effect of IIH is through its effect on optic nerve (papilledema) leading to visual field defect, horizontal double vision and finally decrease of visual acuity. Despite this, these presentations may not appears collectively and patient can come with one or two of vague symptoms as in IIH without papilledema variant[5]. So IIH needs an accurate, trusted, and rapid tool for diagnosis and follow up. Modified Dandy criteria[6,7] gives an informative description for IIH and a differentiation from other causes of increase intracranial pressure through; Signs and symptoms of increased intracranial pressure, Absence of localizing findings on neurologic examination, Absence of deformity, displacement, or obstruction of the ventricular system except for evidence of increased cerebrospinal fluid pressure (greater than 200 mm water)[8]. Normal neuroimaging except for empty sella turcica, optic nerve sheath with filled out CSF spaces, and smooth-walled non flow-related venous sinus stenosis or collapse should lead to another diagnosis, No other cause of increased intracranial pressure present for CSF opening pressure of 200 to 250 mm water.
The clinical presentation of the disease is heterogeneous and often not correlating with the objective findings such as lumbar puncture opening pressure and papilledema. Currently, it is not possible to predict if a patient will respond to medical treatment, or which patients may develop severe permanent visual loss. Papilledema, the only non-invasive objective measurable treatment response, develops with substantial delay compared to intracranial pressure. Therefore, an objective tool indicating permanent optic nerve damage is sorely needed and will help guide treatment and predicting disease outcome. Biomarkers have this advantage as they allow early predicting optic nerve damage. For that reason CSF biomarkers deserve precise understanding for there rule in IIH which is the aim of our study.
- Conditions
- Intracranial Hypertension
- Being tested
- lumper puncture
- Keywords
- biomarkers
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumper punctureDiagnostic test
lumper puncture
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: lumper puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Neurofilament light chain(NLC)
- Hypoxia induced factor(HIF)
Measured: 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
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Dec 2021
- Primary completion20 Nov 2022
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebrahim Ahmed Yousof Abdelhakeem, Assiut University
- Investigators
- Mahmoud H Ragab, professor, Study chair, professorAbdelhakeem A Essa, Ass. prof., Study director, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647837
- Sponsor's protocol ID
- CSF biomarkers
- Status last verified
- Nov 2022
- First submitted
- 22 Oct 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32335853Sinclair 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.
PubMed 18676028
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Cerebrospinal Fluid (CSF) Biomarkers in Patients of Idiopathic Intracranial Hypertension (IIH) as an Indicative of Visual Affection and Treatment Modalities
- ClinicalTrials.gov ID
- NCT05647837
- Acronym / sponsor ID
- CSF biomarkers
- Conditions
- Intracranial Hypertension
- Keywords
- biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- Mar 2023 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Idiopathic intracranial hypertension (IIH) is a rare disease of increasing incidence recently[1], owing to the rising curve of obesity and weight gain[2,3]. It is a disease of elevated intracranial pressure without known obvious aetiology. The reported incidence of IIH is 1 to 3 cases per 100,000 people of the general population[4]. IIH is diagnosed by exclusion; as patients come with continuous headache repeated vomiting , pulsatile tinnitus and the hall landmark of this disease, visual disturbance. One of the most deleterious effect of IIH is through its effect on optic nerve (papilledema) leading to visual field defect, horizontal double vision and finally decrease of visual acuity. Despite this, these presentations may not appears collectively and patient can come with one or two of vague symptoms as in IIH without papilledema variant[5]. So IIH needs an accurate, trusted, and rapid tool for diagnosis and follow up. Modified Dandy criteria[6,7] gives an informative description for IIH and a differentiation from other causes of increase intracranial pressure through; Signs and symptoms of increased intracranial pressure, Absence of localizing findings on neurologic examination, Absence of deformity, displacement, or obstruction of the ventricular system except for evidence of increased cerebrospinal fluid pressure (greater than 200 mm water)[8]. Normal neuroimaging except for empty sella turcica, optic nerve sheath with filled out CSF spaces, and smooth-walled non flow-related venous sinus stenosis or collapse should lead to another diagnosis, No other cause of increased intracranial pressure present for CSF opening pressure of 200 to 250 mm water.
The clinical presentation of the disease is heterogeneous and often not correlating with the objective findings such as lumbar puncture opening pressure and papilledema. Currently, it is not possible to predict if a patient will respond to medical treatment, or which patients may develop severe permanent visual loss. Papilledema, the only non-invasive objective measurable treatment response, develops with substantial delay compared to intracranial pressure. Therefore, an objective tool indicating permanent optic nerve damage is sorely needed and will help guide treatment and predicting disease outcome. Biomarkers have this advantage as they allow early predicting optic nerve damage. For that reason CSF biomarkers deserve precise understanding for there rule in IIH which is the aim of our study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients wit IIH | Experimental | Diagnostic Test: lumper puncturepatient 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1. All patients with signs and symptoms of increased intracranial pressure (headaches, nausea, vomiting, transient visual obscurations, papilledema).
- 2. CSF opening pressure >25 cm water with normal CSF composition.
Key exclusion criteria (3 listed)
- 1. localizing neurologic signs, except for unilateral or bilateral sixth cranial nerve palsy.
- 2. Evidence of hydrocephalus, mass, infection, structural, or vascular lesion (including venous sinus thrombosis) on imaging.
- 3. Patients with IIH who undergo surgical intervention (thecoperitoneal shunt or optic nerve fenestration) 4. Other identified causes of increased ICP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumper puncturelumper puncture | Diagnostic test | patients wit IIH |
Primary outcome
Relation between lumper puncture opening pressure and specific biomarkers
Time frame: Baseline
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)
Relation between lumper puncture opening pressure and visual disturbance
Time frame: 3 days
Clinical and visual assessment and CSF opening pressure measurement. measurement tools: Ophthalmoscope Measuring grades of papilledema using the Frisén scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Background: PubMed 32335853Kalyvas 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.
- Background: PubMed 18676028Sinclair 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud H Ragab, professor study chair
professor
Abdelhakeem A Essa, Ass. prof. study director
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumper puncture in people with Intracranial Hypertension, run by Assiut University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Dec 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebrahim A Yousuf, master (01118550865, Ebrahim.20133765@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between lumper puncture opening pressure and specific biomarkers (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT05647837, which also lists 2 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 13 Dec 2022.