Status:
COMPLETED
Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler
Lead Sponsor:
Danish Headache Center
Conditions:
Idiopathic Intracranial Hypertension
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Idiopathic Intracranial Hypertension (IIH) is a rare disease, primarily affecting overweight females of child-bearing age. Patients suffer from increased intracranial pressure (ICP), typically resulti...
Detailed 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 ophthalmol...
Eligibility Criteria
Inclusion
- PATIENT GROUP (ARM 1):
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04314128
Start Date
January 1 2020
End Date
February 1 2023
Last Update
March 7 2023
Active Locations (1)
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1
Danish Headache Center
Glostrup Municipality, Capital Region, Denmark, 2600