Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transc… (NCT04314128) | Clinical Trial Compass
CompletedNot Applicable
Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler
Denmark78 participantsStarted 2020-01-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between opening pressure and ONSD
Timeframe: 1 year
2
Correlaton between opening pressure and ONSD/ETD ratio