Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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:
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IIH is suspected
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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:
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Certain IIH or IIH-WOP
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Suspected, but unconfirmed, IIH
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IIH ruled out
Patients are followed at a headache center and by neuro-ophthalmologist according to standard clinical practice.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Certain IIH or IIH-WOP According to revised diagnostic criteria, Friedmann, 2013. |
Other: Standard treatment
No intervention, some patients have additional neuro-psychological testing.
|
| Suspected IIH IIH is suspected, does not fulfill diagnostic criteria. |
Other: Standard treatment
No intervention, some patients have additional neuro-psychological testing.
|
| IIH ruled out Patients in whom another diagnosis is made. |
Other: Standard treatment
No intervention, some patients have additional neuro-psychological testing.
|
Outcome Measures
Primary Outcome Measures
- Biomarkers of IIH (diagnostic and prognostic) [2 years]
Analyses of CSF and blood for protein-markers (method: Proteomics)
- Visual status at conclusion of study [2 years]
Assessment of visual fields
- Visual status at conclusion of study [2 years]
Assessment of OCT
- Visual status at conclusion of study [2 years]
Assessment of visual acuity
- Headache status at conclusion of study [2 years]
Prevalence of chronic headache (>=15 headache days per month)
- Biomarkers of IIH (diagnostic and prognostic) [2 years]
Analyses of CSF and blood for markers of metabolism (method: Metabolomics)
Secondary Outcome Measures
- Baseline characteristics related to poor outcome [1 year]
Poor outcome is defined as either a.) Persistent visual field defects, decreased visual acuity after 12 months and or b.) Headache >= 15 days per month after 12 months
- Results of neuropsychological evaluations [1 year]
Standard neuro-psychological tests
- Treatment and follow-up [3 years]
Length and type of treatment and follow-up
- Baseline characteristics related to IIH diagnosis [2 years]
Evaluation of disease presentation in the different sub-groups focusing on headache phenotype, visual disturbances and pulsatile tinnitus.
- Weight change in a standard care program [2 years]
Unit of measurement is BMI
- Diagnostic criteria and their use in the clinical setting [2 years]
Revised Friedmann criteria of 2013
- Clinical markers related to disease activity [2 years]
Clinical markers of relevance: Headache phenotype, pulsatile tinnitus, visual disturbances, weight changes.
- Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline [2 years]
ICP is measured by lumbar puncture, borderline elevated ICP is considered >20-30 mmH2O
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able to and willing to provide informed consent
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More than 18 years of age
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Suspicion of IIH (based on clinical evaluation by neurologist or opthalmologist)
Exclusion Criteria:
1.) Unable to consent (e.g. language, mental retardation).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup | Copenhagen | Glostrup | Denmark | 2600 |
| 2 | Odense University Hospital, Department of Neurology | Odense | Region Syddanmark | Denmark | 5000 |
Sponsors and Collaborators
- Danish Headache Center
- Odense University Hospital
Investigators
- Study Director: Rigmor Jensen, M.D., Dr.Med., The Danish Headache Center, Rigshospitalet-Glostrup
- Study Director: Dagmar Beier, M.D., Ph.D., Odense University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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. Review.
- 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, 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.
- 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, Rönnbäck 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.
- S-20170058