Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Eligibility

Primary outcome measure(s)

• 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)

Trial sites (2)

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