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Completed

NCT Number: NCT04314128

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, Capital Region, 2600, Denmark

About this study

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)

  • An interview (history taking) and clinical examination
  • Routine laboratory tests (blood tests)
  • Ophthalmological examination
  • Lumbar puncture with measurement of the ICP
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TOS and TCD

Diagnostic Test

TOS: Transorbital sonography TCD: Transcranial Doppler

Primary outcomes

  1. Correlation between opening pressure and ONSD

    Time frame: 1 year

    Optic nerve sheath diameter (ONSD) potential correlation with opening pressure.

  2. Correlaton between opening pressure and ONSD/ETD ratio

    Time frame: 1 year

    ONSD/ETD (external transverse diameter) ratio and potential correlation with opening pressure.

  3. Comparison of ONSD in IIH and healthy controls

    Time frame: 1 year

    Comparison of ONSD in patients with elevated ICP (IIH) and healthy controls, age- sex and BMI matched.

Secondary outcomes

  1. Optic disc elevation

    Time frame: 1 year

    Optic disc elevation measured by ultrasound in IIH compared with healthy controls

  2. ONSD diameter on MR c in patients with IIH

    Time frame: 1 year

    ONSD and correlation with ONSD on orbital MRI.

  3. Changes in the optic nerve (ONSD)

    Time frame: 1 month

    Changes in ONSD after 1 month

  4. Changes in the optic nerve (ONSD)

    Time frame: 6 months

    Changes in ONSD after 6 months

  5. Changes in the optic nerve (ODE)

    Time frame: 1 month

    Changes in ODE (optic disc elevation) after 1 month

  6. Changes in the optic nerve (ODE)

    Time frame: 6 months

    Changes in ODE(optic disc elevation) after 6 months

  7. TCD (PI - pulsatility index) in patients with IIH

    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.

  8. TCD (MBFV - mean blood flow velocity) in patients with IIH

    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.

  9. TCD (RI - resistance index) in patients with IIH

    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.

  10. Neuro-ophthalmological evaluation of papilledema versus ultrasound evaluation of the optic nerve

    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.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 19, 2020
Registry last updated
Mar 7, 2023

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.

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