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
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.
Study Type
OBSERVATIONAL
Enrollment
300
No intervention, some patients have additional neuro-psychological testing.
The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup
Copenhagen, Glostrup, Denmark
RECRUITINGOdense University Hospital, Department of Neurology
Odense, Region Syddanmark, Denmark
RECRUITINGBiomarkers of IIH (diagnostic and prognostic)
Analyses of CSF and blood for protein-markers (method: Proteomics)
Time frame: 2 years
Visual status at conclusion of study
Assessment of visual fields
Time frame: 2 years
Visual status at conclusion of study
Assessment of OCT
Time frame: 2 years
Visual status at conclusion of study
Assessment of visual acuity
Time frame: 2 years
Headache status at conclusion of study
Prevalence of chronic headache (\>=15 headache days per month)
Time frame: 2 years
Biomarkers of IIH (diagnostic and prognostic)
Analyses of CSF and blood for markers of metabolism (method: Metabolomics)
Time frame: 2 years
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
Time frame: 1 year
Results of neuropsychological evaluations
Standard neuro-psychological tests
Time frame: 1 year
Treatment and follow-up
Length and type of treatment and follow-up
Time frame: 3 years
Baseline characteristics related to IIH diagnosis
Evaluation of disease presentation in the different sub-groups focusing on headache phenotype, visual disturbances and pulsatile tinnitus.
Time frame: 2 years
Weight change in a standard care program
Unit of measurement is BMI
Time frame: 2 years
Diagnostic criteria and their use in the clinical setting
Revised Friedmann criteria of 2013
Time frame: 2 years
Clinical markers related to disease activity
Clinical markers of relevance: Headache phenotype, pulsatile tinnitus, visual disturbances, weight changes.
Time frame: 2 years
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
Time frame: 2 years
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