Idiopathic Intracranial Hypertension (IIH) is a rare disease, primarily affecting overweight females of child-bearing age. Patients suffer from increased intracranial pressure (ICP), typically resulting in headaches, visual disturbances and bilateral papilledema, pulsatile tinnitus and cognitive deficits. The disease is difficult to diagnose, treat and monitor. The only current method of measuring the ICP in day-to-day clinical practice is by lumbar puncture. This procedure is invasive, and often painful for the patient. There is an unmet need of methods that can reliable measure or estimate ICP in a non-invasive manner. Ultrasound is one such potential method, and the aim of this study is to investigate the use of ocular ultrasound and transcranial doppler to measure or estimate ICP.
This study is a prospective cohort study. Investigators plan to include 50 patients in whom the IIH-diagnosis is suspected. Patients are referred from general practitioners, neurologists or ophthalmologists to the Danish Headache Center or admitted to the Neurology ward when the IIH diagnosis is suspected. As part of an established routine clinical work-up to establish the diagnosis of IIH, all patients will undergo (according to the Friedman criteria) the following examinations: A) 1. An interview (history taking) and clinical examination 2. Routine laboratory tests (blood tests) 3. Ophthalmological examination 4. Lumbar puncture with measurement of the ICP 5. Magnetic resonance imaging (MRI) of the brain Additionally the following investigations will be performed at baseline (before and after lumbar puncture): B) Transorbital sonography (TOS) C) Transcranial Doppler When the patient is seen at the clinic for their regular follow-up visits the same measurements will be done. A control group of healthy participants (NR=25) will be included in whom TOS (B) and TCD (C) will be performed in order to compare the values between the patient group (IIH) and control group. Controls will be included to match the patients according to BMI, age and gender. All ultrasound images- and films will be saved, and evaluated by a blinded investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
78
TOS: Transorbital sonography TCD: Transcranial Doppler
Danish Headache Center
Glostrup Municipality, Capital Region, Denmark
Correlation between opening pressure and ONSD
Optic nerve sheath diameter (ONSD) potential correlation with opening pressure.
Time frame: 1 year
Correlaton between opening pressure and ONSD/ETD ratio
ONSD/ETD (external transverse diameter) ratio and potential correlation with opening pressure.
Time frame: 1 year
Comparison of ONSD in IIH and healthy controls
Comparison of ONSD in patients with elevated ICP (IIH) and healthy controls, age- sex and BMI matched.
Time frame: 1 year
Optic disc elevation
Optic disc elevation measured by ultrasound in IIH compared with healthy controls
Time frame: 1 year
ONSD diameter on MR c in patients with IIH
ONSD and correlation with ONSD on orbital MRI.
Time frame: 1 year
Changes in the optic nerve (ONSD)
Changes in ONSD after 1 month
Time frame: 1 month
Changes in the optic nerve (ONSD)
Changes in ONSD after 6 months
Time frame: 6 months
Changes in the optic nerve (ODE)
Changes in ODE (optic disc elevation) after 1 month
Time frame: 1 month
Changes in the optic nerve (ODE)
Changes in ODE(optic disc elevation) after 6 months
Time frame: 6 months
TCD (PI - pulsatility index) in patients with IIH
Evaluation of pulsatility index for major intracranial arteries (PI) using doppler ultrasound in patients with raised intracranial pressure (IIH) compared with normal values.
Time frame: 2 years
TCD (MBFV - mean blood flow velocity) in patients with IIH
Evaluation of mean blood flow velocity (MBFV) for major intracranial arteries using doppler ultrasound in patients with raised intracranial pressure (IIH) compared with normal values.
Time frame: 2 years
TCD (RI - resistance index) in patients with IIH
Evaluation of resistance index (RI) for major intracranial arteries using doppler ultrasound in patients with raised intracranial pressure (IIH) compared with normal values.
Time frame: 2 years
Neuro-ophthalmological evaluation of papilledema versus ultrasound evaluation of the optic nerve
Papilledema and the optic nerve is usually evaluated by neuro-ophthalmologists in patients with IIH. Investigators will compare this evaluation with the assessment made by TOS ultrasound.
Time frame: 2 years
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