Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler

  • STATUS
    Recruiting
  • End date
    Apr 1, 2029
  • participants needed
    75
  • sponsor
    Danish Headache Center
Updated on 24 January 2021

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.

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.

Details
Condition Pseudotumor Cerebri
Treatment TOS and TCD
Clinical Study IdentifierNCT04314128
SponsorDanish Headache Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have Pseudotumor Cerebri?
Do you have any of these conditions: Do you have Pseudotumor Cerebri??
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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