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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients suspected of IIH at baseline | Other | Intervention: TOS and TCD measurements at baseline, and at routine follow-ups. Healthy controls will be recruited to match the patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOS and TCD | Diagnostic Test | TOS: Transorbital sonography TCD: Transcranial Doppler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between opening pressure and ONSD | Optic nerve sheath diameter (ONSD) potential correlation with opening pressure. | 1 year |
| Correlaton between opening pressure and ONSD/ETD ratio | ONSD/ETD (external transverse diameter) ratio and potential correlation with opening pressure. | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Optic disc elevation | Optic disc elevation measured by ultrasound in IIH compared with healthy controls | 1 year |
| ONSD diameter on MR c in patients with IIH | ONSD and correlation with ONSD on orbital MRI. |
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PATIENT GROUP (ARM 1):
Inclusion Criteria:
Exclusion Criteria:
CONTROL GROUP (ARM 2):
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rigmor Jensen, Dr.med. | Danish Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Glostrup Municipality | Capital Region | 2600 | Denmark |
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| ID | Term |
|---|---|
| D011559 | Pseudotumor Cerebri |
| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D017585 | Ultrasonography, Doppler, Transcranial |
| ID | Term |
|---|---|
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
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Single group, prospective cohort study with healthy controls.
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| 1 year |
| Changes in the optic nerve (ONSD) | Changes in ONSD after 1 month | 1 month |
| Changes in the optic nerve (ONSD) | Changes in ONSD after 6 months | 6 months |
| Changes in the optic nerve (ODE) | Changes in ODE (optic disc elevation) after 1 month | 1 month |
| Changes in the optic nerve (ODE) | Changes in ODE(optic disc elevation) after 6 months | 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. | 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. | 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. | 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. | 2 years |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |