Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Benign Intracranial Hypertension Clinical Trial

Official title:

Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04032379
• Other study ID #: S-20170058
• Status: Recruiting
• Start date: February 14, 2018
• Est. completion date: May 31, 2027

Study information

• Verified date: March 2023
• Source: Danish Headache Center
• Contact: Johanne Severinsen, M.D.
• Phone: 004538633553
• Email: johanne.juhl.severinsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to and willing to provide informed consent

2. More than 18 years of age

3. Suspicion of IIH (based on clinical evaluation by neurologist or opthalmologist)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Benign Intracranial Hypertension
• Hypertension
• Intracranial Hypertension
• Pseudotumor Cerebri

Intervention

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

Locations

Country	Name	City	State
Denmark	The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup	Copenhagen	Glostrup
Denmark	Odense University Hospital, Department of Neurology	Odense	Region Syddanmark

Sponsors (2)

Lead Sponsor	Collaborator
Danish Headache Center	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of IIH (diagnostic and prognostic)	Analyses of CSF and blood for protein-markers (method: Proteomics)	2 years
Primary	Visual status at conclusion of study	Assessment of visual fields	2 years
Primary	Visual status at conclusion of study	Assessment of OCT	2 years
Primary	Visual status at conclusion of study	Assessment of visual acuity	2 years
Primary	Headache status at conclusion of study	Prevalence of chronic headache (>=15 headache days per month)	2 years
Primary	Biomarkers of IIH (diagnostic and prognostic)	Analyses of CSF and blood for markers of metabolism (method: Metabolomics)	2 years
Secondary	Baseline characteristics related to poor outcome	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	1 year
Secondary	Results of neuropsychological evaluations	Standard neuro-psychological tests	1 year
Secondary	Treatment and follow-up	Length and type of treatment and follow-up	3 years
Secondary	Baseline characteristics related to IIH diagnosis	Evaluation of disease presentation in the different sub-groups focusing on headache phenotype, visual disturbances and pulsatile tinnitus.	2 years
Secondary	Weight change in a standard care program	Unit of measurement is BMI	2 years
Secondary	Diagnostic criteria and their use in the clinical setting	Revised Friedmann criteria of 2013	2 years
Secondary	Clinical markers related to disease activity	Clinical markers of relevance: Headache phenotype, pulsatile tinnitus, visual disturbances, weight changes.	2 years
Secondary	Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline	ICP is measured by lumbar puncture, borderline elevated ICP is considered >20-30 mmH2O	2 years