Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard treatment.
- Who it may be relevant to
- Registry conditions: Benign Intracranial Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Idiopathic intracranial hypertension (IIH) is a condition of unknown etiology, primarily affecting overweight females of childbearing age. Typically, patients experience headache and visual symptoms due to increased intracranial pressure (ICP) and papilledema. The diagnosis is difficult, and outcomes vary from no sequelae to blindness or chronic headaches. No clear prognostic indicators exist. Treatment consists of medication, weight loss, and possibly surgical intervention.There is an unmet need of defining biomarkers with prognostic or diagnostic value and defining predictors of a poor outcome. 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
Detailed description
This study is a multicenter, prospective, population-based cohort study with consecutive inclusion of patients in which the diagnosis of IIH is suspected. This study is carried out in collaboration between the Danish Headache Center, Rigshospitalet-Glostrup, and the Neurological Department at Odense University Hospital.
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.
Interventions
- Other Standard treatment
No intervention, some patients have additional neuro-psychological testing.
Primary outcome measures
- Biomarkers of IIH (diagnostic and prognostic) [Time frame: 2 years]
- Visual status at conclusion of study [Time frame: 2 years]
- Visual status at conclusion of study [Time frame: 2 years]
- Visual status at conclusion of study [Time frame: 2 years]
- Headache status at conclusion of study [Time frame: 2 years]
- Biomarkers of IIH (diagnostic and prognostic) [Time frame: 2 years]
Secondary outcome measures (8)
- Baseline characteristics related to poor outcome [Time frame: 1 year]
- Results of neuropsychological evaluations [Time frame: 1 year]
- Treatment and follow-up [Time frame: 3 years]
- Baseline characteristics related to IIH diagnosis [Time frame: 2 years]
- Weight change in a standard care program [Time frame: 2 years]
- Diagnostic criteria and their use in the clinical setting [Time frame: 2 years]
- Clinical markers related to disease activity [Time frame: 2 years]
- Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Able to and willing to provide informed consent
- More than 18 years of age
- Suspicion of IIH (based on clinical evaluation by neurologist or opthalmologist)
Exclusion criteria
1.) Unable to consent (e.g. language, mental retardation).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 2 centers
- The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup — Copenhagen
- Odense University Hospital, Department of Neurology — Odense
Publications
- 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. PMID 3395261
- 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. PMID 24756302
- 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. PMID 25228684
- 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. PMID 25070715
- 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. PMID 24713214
- 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. PMID 19222592
- 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. PMID 23165338
- 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. PMID 23771276
Identifiers
NCT: NCT04032379 · S-20170058