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Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04032379
Enrollment
300
Registered
2019-07-25
Start date
2018-02-14
Completion date
2027-05-31
Last updated
2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Intracranial Hypertension

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

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: 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.

Interventions

OTHERStandard treatment

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

Sponsors

Odense University Hospital
CollaboratorOTHER
Danish Headache Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Biomarkers of IIH (diagnostic and prognostic)2 yearsAnalyses of CSF and blood for protein-markers (method: Proteomics)
Visual status at conclusion of study2 yearsAssessment of visual fields
Headache status at conclusion of study2 yearsPrevalence of chronic headache (\>=15 headache days per month)

Secondary

MeasureTime frameDescription
Baseline characteristics related to IIH diagnosis2 yearsEvaluation of disease presentation in the different sub-groups focusing on headache phenotype, visual disturbances and pulsatile tinnitus.
Weight change in a standard care program2 yearsUnit of measurement is BMI
Treatment and follow-up3 yearsLength and type of treatment and follow-up
Clinical markers related to disease activity2 yearsClinical 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 baseline2 yearsICP is measured by lumbar puncture, borderline elevated ICP is considered \>20-30 mmH2O
Diagnostic criteria and their use in the clinical setting2 yearsRevised Friedmann criteria of 2013
Baseline characteristics related to poor outcome1 yearPoor 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 evaluations1 yearStandard neuro-psychological tests

Countries

Denmark

Contacts

Primary ContactJohanne Severinsen, M.D.
johanne.juhl.severinsen@regionh.dk004538633553

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026