Health TrialsbyHealthPanel

Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

ConditionBenign Intracranial Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDanish Headache Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial population

All admitted or out-patient referrals where IIH is suspected. Patients will be identified and included consecutively once there is a clinical suspicion of IIH, if they wish to participate. Most often IIH will be suspected in a typical patient (female, child-bearing age, overweight) with either bilateral papiledema and normal neuro-imaging, high ICP by lumbar puncture or a new headache with associated visual disturbances or pulsatile tinnitus. All hospitals in the Capital Region of Denmark and the Southern Region of Denmark can participate and refer patients.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard treatment

    Other intervention

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

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Certain IIH or IIH-WOP1 intervention
Group B: Suspected IIH1 intervention
Group C: IIH ruled out1 intervention

Trial outcomes

Primary outcomes

1

Biomarkers of IIH (diagnostic and prognostic)

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

Time frame
2 years
2

Visual status at conclusion of study

Assessment of visual fields

Time frame
2 years
3

Visual status at conclusion of study

Assessment of OCT

Time frame
2 years
4

Visual status at conclusion of study

Assessment of visual acuity

Time frame
2 years

Secondary outcomes

1

Baseline characteristics related to poor outcome

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

Time frame
1 year
2

Results of neuropsychological evaluations

Standard neuro-psychological tests

Time frame
1 year
3

Treatment and follow-up

Length and type of treatment and follow-up

Time frame
3 years
4

Baseline characteristics related to IIH diagnosis

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

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danish Headache Center

Lead sponsor

Odense University Hospital

Collaborator

Source ClinicalTrials.gov
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