Clinical trial NCT04314128: Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler
Official title: Assessment of Raised Intracranial Pressure in Patients With Idiopathic Intracranial Hypertension by Optic Nerve Sheath Diameter and Transcranial Doppler Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Intracranial Hypertension
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, prospective cohort study with healthy controls.
Primary purpose: DIAGNOSTIC

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Correlation between opening pressure and ONSD
timeFrame: 1 year
measure: Correlaton between opening pressure and ONSD/ETD ratio
timeFrame: 1 year
measure: Comparison of ONSD in IIH and healthy controls
timeFrame: 1 year
Secondary outcomes:
measure: Optic disc elevation
timeFrame: 1 year
measure: ONSD diameter on MR c in patients with IIH
timeFrame: 1 year
measure: Changes in the optic nerve (ONSD)
timeFrame: 1 month
measure: Changes in the optic nerve (ONSD)
timeFrame: 6 months
measure: Changes in the optic nerve (ODE)
timeFrame: 1 month
measure: Changes in the optic nerve (ODE)
timeFrame: 6 months
measure: TCD (PI - pulsatility index) in patients with IIH
timeFrame: 2 years
measure: TCD (MBFV - mean blood flow velocity) in patients with IIH
timeFrame: 2 years
measure: TCD (RI - resistance index) in patients with IIH
timeFrame: 2 years
measure: Neuro-ophthalmological evaluation of papilledema versus ultrasound evaluation of the optic nerve
timeFrame: 2 years
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Region Hovedstaden
Study officials:
affiliation: Danish Headache Center
name: Rigmor Jensen, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: