Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
- Conditions
- Benign Intracranial Hypertension
- Interventions
- Other: Standard treatment
- Registration Number
- NCT04032379
- Lead Sponsor
- Danish Headache Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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)
1.) Unable to consent (e.g. language, mental retardation).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Certain IIH or IIH-WOP Standard treatment According to revised diagnostic criteria, Friedmann, 2013. IIH ruled out Standard treatment Patients in whom another diagnosis is made. Suspected IIH Standard treatment IIH is suspected, does not fulfill diagnostic criteria.
- Primary Outcome Measures
Name Time Method Biomarkers of IIH (diagnostic and prognostic) 2 years Analyses of CSF and blood for markers of metabolism (method: Metabolomics)
Headache status at conclusion of study 2 years Prevalence of chronic headache (\>=15 headache days per month)
Visual status at conclusion of study 2 years Assessment of visual acuity
- Secondary Outcome Measures
Name Time Method Baseline characteristics related to IIH diagnosis 2 years Evaluation of disease presentation in the different sub-groups focusing on headache phenotype, visual disturbances and pulsatile tinnitus.
Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline 2 years ICP is measured by lumbar puncture, borderline elevated ICP is considered \>20-30 mmH2O
Baseline characteristics related to poor outcome 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
Results of neuropsychological evaluations 1 year Standard neuro-psychological tests
Clinical markers related to disease activity 2 years Clinical markers of relevance: Headache phenotype, pulsatile tinnitus, visual disturbances, weight changes.
Treatment and follow-up 3 years Length and type of treatment and follow-up
Weight change in a standard care program 2 years Unit of measurement is BMI
Diagnostic criteria and their use in the clinical setting 2 years Revised Friedmann criteria of 2013
Trial Locations
- Locations (2)
The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup
🇩🇰Copenhagen, Glostrup, Denmark
Odense University Hospital, Department of Neurology
🇩🇰Odense, Region Syddanmark, Denmark