Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04032379

Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Benign Intracranial Hypertension Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases Pseudotumor Cerebri

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Copenhagen, Glostrup, Denmark

Loading trial locations.

About this study

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:

  • IIH is suspected
  • > 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:

  • Certain IIH or IIH-WOP
  • Suspected, but unconfirmed, IIH
  • IIH ruled out

Patients are followed at a headache center and by neuro-ophthalmologist according to standard clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

standard treatment

Other

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

Primary outcomes

  1. Biomarkers of IIH (diagnostic and prognostic)

    Time frame: 2 years

    Analyses of CSF and blood for protein-markers (method: Proteomics)

  2. Visual status at conclusion of study

    Time frame: 2 years

    Assessment of visual fields

  3. Visual status at conclusion of study

    Time frame: 2 years

    Assessment of OCT

  4. Visual status at conclusion of study

    Time frame: 2 years

    Assessment of visual acuity

  5. Headache status at conclusion of study

    Time frame: 2 years

    Prevalence of chronic headache (>=15 headache days per month)

  6. Biomarkers of IIH (diagnostic and prognostic)

    Time frame: 2 years

    Analyses of CSF and blood for markers of metabolism (method: Metabolomics)

Secondary outcomes

  1. Baseline characteristics related to poor outcome

    Time frame: 1 year

    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

  2. Results of neuropsychological evaluations

    Time frame: 1 year

    Standard neuro-psychological tests

  3. Treatment and follow-up

    Time frame: 3 years

    Length and type of treatment and follow-up

  4. Baseline characteristics related to IIH diagnosis

    Time frame: 2 years

    Evaluation of disease presentation in the different sub-groups focusing on headache phenotype, visual disturbances and pulsatile tinnitus.

  5. Weight change in a standard care program

    Time frame: 2 years

    Unit of measurement is BMI

  6. Diagnostic criteria and their use in the clinical setting

    Time frame: 2 years

    Revised Friedmann criteria of 2013

  7. Clinical markers related to disease activity

    Time frame: 2 years

    Clinical markers of relevance: Headache phenotype, pulsatile tinnitus, visual disturbances, weight changes.

  8. Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline

    Time frame: 2 years

    ICP is measured by lumbar puncture, borderline elevated ICP is considered >20-30 mmH2O

Study contacts

Contact information is provided by the study sponsor or research team.

Johanne Severinsen, M.D.

CONTACT

[email protected]

004538633553

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Collaborators

  • Odense University Hospital

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2019
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.