Danish Headache Center
Glostrup Municipality, Capital Region, 2600, Denmark
NCT Number: NCT04314128
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Glostrup Municipality, Capital Region, 2600, Denmark
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)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
PATIENT GROUP (ARM 1):
Inclusion criteria
Exclusion criteria
CONTROL GROUP (ARM 2):
Inclusion criteria
Exclusion criteria
TOS: Transorbital sonography TCD: Transcranial Doppler
Time frame: 1 year
Optic nerve sheath diameter (ONSD) potential correlation with opening pressure.
Time frame: 1 year
ONSD/ETD (external transverse diameter) ratio and potential correlation with opening pressure.
Time frame: 1 year
Comparison of ONSD in patients with elevated ICP (IIH) and healthy controls, age- sex and BMI matched.
Time frame: 1 year
Optic disc elevation measured by ultrasound in IIH compared with healthy controls
Time frame: 1 year
ONSD and correlation with ONSD on orbital MRI.
Time frame: 1 month
Changes in ONSD after 1 month
Time frame: 6 months
Changes in ONSD after 6 months
Time frame: 1 month
Changes in ODE (optic disc elevation) after 1 month
Time frame: 6 months
Changes in ODE(optic disc elevation) after 6 months
Time frame: 2 years
Evaluation of pulsatility index for major intracranial arteries (PI) using doppler ultrasound in patients with raised intracranial pressure (IIH) compared with normal values.
Time frame: 2 years
Evaluation of mean blood flow velocity (MBFV) for major intracranial arteries using doppler ultrasound in patients with raised intracranial pressure (IIH) compared with normal values.
Time frame: 2 years
Evaluation of resistance index (RI) for major intracranial arteries using doppler ultrasound in patients with raised intracranial pressure (IIH) compared with normal values.
Time frame: 2 years
Papilledema and the optic nerve is usually evaluated by neuro-ophthalmologists in patients with IIH. Investigators will compare this evaluation with the assessment made by TOS ultrasound.
Danish Headache Center
Other
Assessment of Raised Intracranial Pressure in Patients With Idiopathic Intracranial Hypertension by Optic Nerve Sheath Diameter and Transcranial Doppler Measurements
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06027567
Body Weight, Body Weight Changes
Odense, Denmark
View Trial DetailsNCT05762367
Brain Diseases, Central Nervous System Diseases
Paris, Île-de-France Region, France
View Trial DetailsNCT02017444
Blindness, Body Weight
Birmingham, West Midlands, United Kingdom
View Trial DetailsNCT03867461
Brain Diseases, Central Nervous System Diseases
Winston-Salem, North Carolina, United States
View Trial Details