Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
NCT ID: NCT04032379
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2018-02-14
2027-05-31
Brief Summary
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This project is a prospective, population-based cohort study including clinical data and a biobank (blood samples and cerebrospinal fluid).
The investigator's primary aim is to identify biomarkers of diagnostic or prognostic value and to create a clinical IIH database. The clinical database will answer questions about patient characteristics at baseline and during follow-up, identify predictors of outcome, and help create a standardized programme for follow-up and
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Detailed Description
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Patients are eligible for inclusion into the study if:
1. IIH is suspected
2. \> 18 years old and able to provide written informed consent.
At baseline included patients will have:
A.) Medical history B.) Neurological, ophthalmological and general medical examination C.) Relevant neuro-imaging D.) Blood samples and lumbar puncture F.) Evaluation by other specialist, including neuro-psychologists, if appropriate.
Subsequently patients are divided into three sub-groups according to revised Friedmann criteria:
1. Certain IIH or IIH-WOP
2. Suspected, but unconfirmed, IIH
3. IIH ruled out
Patients are followed at a headache center and by neuro-ophthalmologist according to standard clinical practice.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Certain IIH or IIH-WOP
According to revised diagnostic criteria, Friedmann, 2013.
Standard treatment
No intervention, some patients have additional neuro-psychological testing.
Suspected IIH
IIH is suspected, does not fulfill diagnostic criteria.
Standard treatment
No intervention, some patients have additional neuro-psychological testing.
IIH ruled out
Patients in whom another diagnosis is made.
Standard treatment
No intervention, some patients have additional neuro-psychological testing.
Interventions
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Standard treatment
No intervention, some patients have additional neuro-psychological testing.
Eligibility Criteria
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Inclusion Criteria
2. More than 18 years of age
3. Suspicion of IIH (based on clinical evaluation by neurologist or opthalmologist)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Danish Headache Center
OTHER
Responsible Party
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Johanne Severinsen
Clinical assistant, M.D.
Principal Investigators
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Rigmor Jensen, M.D., Dr.Med.
Role: STUDY_DIRECTOR
The Danish Headache Center, Rigshospitalet-Glostrup
Dagmar Beier, M.D., Ph.D.
Role: STUDY_DIRECTOR
Odense University Hospital
Locations
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The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup
Copenhagen, Glostrup, Denmark
Odense University Hospital, Department of Neurology
Odense, Region Syddanmark, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Wall M, Kupersmith MJ, Kieburtz KD, Corbett JJ, Feldon SE, Friedman DI, Katz DM, Keltner JL, Schron EB, McDermott MP; NORDIC Idiopathic Intracranial Hypertension Study Group. The idiopathic intracranial hypertension treatment trial: clinical profile at baseline. JAMA Neurol. 2014 Jun;71(6):693-701. doi: 10.1001/jamaneurol.2014.133.
Yri HM, Jensen RH. Idiopathic intracranial hypertension: Clinical nosography and field-testing of the ICHD diagnostic criteria. A case-control study. Cephalalgia. 2015 Jun;35(7):553-62. doi: 10.1177/0333102414550109. Epub 2014 Sep 16.
Yri HM, Ronnback C, Wegener M, Hamann S, Jensen RH. The course of headache in idiopathic intracranial hypertension: a 12-month prospective follow-up study. Eur J Neurol. 2014 Dec;21(12):1458-64. doi: 10.1111/ene.12512. Epub 2014 Jul 29.
Yri HM, Fagerlund B, Forchhammer HB, Jensen RH. Cognitive function in idiopathic intracranial hypertension: a prospective case-control study. BMJ Open. 2014 Apr 8;4(4):e004376. doi: 10.1136/bmjopen-2013-004376.
Digre KB, Nakamoto BK, Warner JE, Langeberg WJ, Baggaley SK, Katz BJ. A comparison of idiopathic intracranial hypertension with and without papilledema. Headache. 2009 Feb;49(2):185-93. doi: 10.1111/j.1526-4610.2008.01324.x.
Peng KP, Fuh JL, Wang SJ. High-pressure headaches: idiopathic intracranial hypertension and its mimics. Nat Rev Neurol. 2012 Dec;8(12):700-10. doi: 10.1038/nrneurol.2012.223. Epub 2012 Nov 20.
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
Nielsen HH, Beck HC, Kristensen LP, Burton M, Csepany T, Simo M, Dioszeghy P, Sejbaek T, Grebing M, Heegaard NH, Illes Z. The Urine Proteome Profile Is Different in Neuromyelitis Optica Compared to Multiple Sclerosis: A Clinical Proteome Study. PLoS One. 2015 Oct 13;10(10):e0139659. doi: 10.1371/journal.pone.0139659. eCollection 2015.
Hansen NS, Korsbaek JJ, Yri HM, Jensen RH, Beier D. Are the ICHD-3 criteria for headache attributed to idiopathic intracranial hypertension valid? Headache phenotyping and field-testing in newly diagnosed idiopathic intracranial hypertension. Cephalalgia. 2024 Apr;44(4):3331024241248210. doi: 10.1177/03331024241248210.
Other Identifiers
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S-20170058
Identifier Type: -
Identifier Source: org_study_id
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