Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Standard treatment
  No intervention, some patients have additional neuro-psychological testing.

Первичные конечные точки

• Biomarkers of IIH (diagnostic and prognostic) [Срок оценки: 2 years]
• Visual status at conclusion of study [Срок оценки: 2 years]
• Visual status at conclusion of study [Срок оценки: 2 years]
• Visual status at conclusion of study [Срок оценки: 2 years]
• Headache status at conclusion of study [Срок оценки: 2 years]
• Biomarkers of IIH (diagnostic and prognostic) [Срок оценки: 2 years]

Вторичные конечные точки (8)

• Baseline characteristics related to poor outcome [Срок оценки: 1 year]
• Results of neuropsychological evaluations [Срок оценки: 1 year]
• Treatment and follow-up [Срок оценки: 3 years]
• Baseline characteristics related to IIH diagnosis [Срок оценки: 2 years]
• Weight change in a standard care program [Срок оценки: 2 years]
• Diagnostic criteria and their use in the clinical setting [Срок оценки: 2 years]
• Clinical markers related to disease activity [Срок оценки: 2 years]
• Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

1.) Unable to consent (e.g. language, mental retardation).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Дания · 2 центра

• The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup — Copenhagen
• Odense University Hospital, Department of Neurology — Odense

Публикации

• 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

Идентификаторы

NCT: NCT04032379 · S-20170058

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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