Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Danish Headache Center

Status: Enrolling

Conditions: Benign Intracranial Hypertension

Treatments: Other: Standard treatment

Study type: Observational

Funder types: Other

Identifiers

NCT04032379

S-20170058

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

300 participants in 3 patient groups

Certain IIH or IIH-WOP

Description:

According to revised diagnostic criteria, Friedmann, 2013.

Treatment:

Other: Standard treatment

Suspected IIH

Description:

IIH is suspected, does not fulfill diagnostic criteria.

Treatment:

Other: Standard treatment

IIH ruled out

Description:

Patients in whom another diagnosis is made.

Treatment:

Other: Standard treatment