Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 02/29/2020 |
| First Submitted: | 03/11/2020 |
| Estimated Enrollment Submitted: | 03/17/2020 |
| First Posted: | 03/18/2020 |
| Last Update Submitted: | 03/17/2020 |
| Last Update Posted: | 03/18/2020 |
| Actual Study Start Date: | 12/31/2019 |
| Estimated Primary Completion Date: | 03/31/2029 |
| Estimated Study Completion Date: | 03/31/2029 |
Condition or disease
Intervention/treatment
Diagnostic Test: Patients suspected of IIH at baseline
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Other: Patients suspected of IIH at baseline Intervention: TOS and TCD measurements at baseline, and at routine follow-ups.
Healthy controls will be recruited to match the patients. | Diagnostic Test: Patients suspected of IIH at baseline TOS: Transorbital sonography TCD: Transcranial Doppler |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | PATIENT GROUP (ARM 1): Inclusion Criteria: - Age 18-65 - Patients in whom the IIH diagnosis is suspected/or confirmed - The diagnosis of migraine with or without aura or tension-type headache is allowed as a comorbid headache type. - Participants must read and understand the Danish language, or have an official interpreter present to be able to understand the work-up and sign the participation consent for the study Exclusion Criteria: - Pregnant or breastfeeding females - Patients who do not need a diagnostic lumbar puncture at the time of evaluation - Patients treated with acetazolamide, topiramate or furosemide for IIH or suspected IIH before inclusion in the study (baseline) - Any other primary or secondary headache diagnosis than migraine with or without aura or tension type headache as a comorbid disorder - Patients in whom the examination cannot be performed due to anatomical reasons such as severe head dysmorphia or severe ophthalmological diseases - Participants with secondary causes of raised intracranial pressure, or patients that have been treated for such (e.g. brain tumor, hydrocephalus, stroke or severe head injury) - Participants with known atherosclerotic disease or known heart disease CONTROL GROUP (ARM 2): Inclusion criteria: - Age 18-65 - Healthy persons who do not suffer from any form of primary headache except infrequent tension-type headache - Participants must read and understand the Danish language or have an official interpreter present to be able to sign the participation consent for the study. Exclusion criteria: - Pregnant or breastfeeding females - Participants in whom the examination cannot be performed due to anatomical reasons such as severe head dysmorphia or severe ophthalmological diseases |
Outcome
Primary Outcome Measures
1. Correlation between opening pressure and ONSD [1 year]
2. Correlaton between opening pressure and ONSD/ETD ratio [1 year]
3. Comparison of ONSD in IIH and healthy controls [1 year]
Secondary Outcome Measures
1. Optic disc elevation [1 year]
2. ONSD diameter on MR c in patients with IIH [1 year]
3. Changes in the optic nerve (ONSD) [1 month]
4. Changes in the optic nerve (ONSD) [6 months]
5. Changes in the optic nerve (ODE) [1 month]
6. Changes in the optic nerve (ODE) [6 months]
7. TCD (PI - pulsatility index) in patients with IIH [2 years]
8. TCD (MBFV - mean blood flow velocity) in patients with IIH [2 years]
9. TCD (RI - resistance index) in patients with IIH [2 years]
10. Neuro-ophthalmological evaluation of papilledema versus ultrasound evaluation of the optic nerve [2 years]
