NCT04314128

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

Assessment of Raised Intracranial Pressure in Patients With Idiopathic Intracranial Hypertension by Optic Nerve Sheath Diameter and Transcranial Doppler Measurements

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Idiopathic Intracranial Hypertension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	TOS and TCD	TOS: Transorbital sonography TCD: Transcranial Doppler

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2020-03-19
• Last updated: 2023-03-07

Locations

1 site across 1 country: Denmark