Idiopathic Intracranial HypertensionNCT04314128
Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler
A study testing TOS and TCD in people with Idiopathic Intracranial Hypertension, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Intracranial Hypertension
- What is being tested?
- TOS and TCD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2020to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- 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)
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- Participants with known atherosclerotic disease or known heart disease
- CONTROL GROUP (ARM 2):
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center
Glostrup Municipality, Capital Region, 2600
About this study
Official title: Assessment of Raised Intracranial Pressure in Patients With Idiopathic Intracranial Hypertension by Optic Nerve Sheath Diameter and Transcranial Doppler Measurements
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.
Read the 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)
- 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):
- 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
- Being tested
- TOS and TCD
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOS and TCDDiagnostic test
TOS: Transorbital sonography TCD: Transcranial Doppler
| Study group | Role | What they receive |
|---|---|---|
| Patients suspected of IIH at baseline | Other | Intervention: TOS and TCD measurements at baseline, and at routine follow-ups.
Healthy controls will be recruited to match the patients. Receives: Diagnostic Test: TOS and TCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between opening pressure and ONSD
Optic nerve sheath diameter (ONSD) potential correlation with opening pressure.
Measured: 1 year
Correlaton between opening pressure and ONSD/ETD ratio
ONSD/ETD (external transverse diameter) ratio and potential correlation with opening pressure.
Measured: 1 year
Comparison of ONSD in IIH and healthy controls
Comparison of ONSD in patients with elevated ICP (IIH) and healthy controls, age- sex and BMI matched.
Measured: 1 year
Secondary outcomes (10)
Optic disc elevation
Optic disc elevation measured by ultrasound in IIH compared with healthy controls
Measured: 1 year
ONSD diameter on MR c in patients with IIH
ONSD and correlation with ONSD on orbital MRI.
Measured: 1 year
Changes in the optic nerve (ONSD)
Changes in ONSD after 1 month
Measured: 1 month
Changes in the optic nerve (ONSD)
Changes in ONSD after 6 months
Measured: 6 months
Changes in the optic nerve (ODE)
Changes in ODE (optic disc elevation) after 1 month
Measured: 1 month
Changes in the optic nerve (ODE)
Changes in ODE(optic disc elevation) after 6 months
Measured: 6 months
TCD (PI - pulsatility index) in patients with IIH
Evaluation of pulsatility index for major intracranial arteries (PI) using doppler ultrasound in patients with raised intracranial pressure (IIH) compared with normal values.
Measured: 2 years
TCD (MBFV - mean blood flow velocity) in patients with IIH
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.
Measured: 2 years
TCD (RI - resistance index) in patients with IIH
Evaluation of resistance index (RI) for major intracranial arteries using doppler ultrasound in patients with raised intracranial pressure (IIH) compared with normal values.
Measured: 2 years
Neuro-ophthalmological evaluation of papilledema versus ultrasound evaluation of the optic nerve
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Jan 2020
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, prospective cohort study with healthy controls.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanne Severinsen, Danish Headache Center
- Investigators
- Rigmor Jensen, Dr.med., Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314128
- Sponsor's protocol ID
- H-19029542
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Raised Intracranial Pressure in Patients With Idiopathic Intracranial Hypertension by Optic Nerve Sheath Diameter and Transcranial Doppler Measurements
- ClinicalTrials.gov ID
- NCT04314128
- Acronym / sponsor ID
- H-19029542
- Conditions
- Idiopathic Intracranial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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):
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, prospective cohort study with healthy controls.
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of IIH at baseline | Other | Diagnostic Test: TOS and TCDIntervention: TOS and TCD measurements at baseline, and at routine follow-ups. Healthy controls will be recruited to match the patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Age 18-65
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOS and TCDTOS: Transorbital sonography TCD: Transcranial Doppler | Diagnostic test | Patients suspected of IIH at baseline |
Primary outcome
Correlation between opening pressure and ONSD
Time frame: 1 year
Optic nerve sheath diameter (ONSD) potential correlation with opening pressure.
Correlaton between opening pressure and ONSD/ETD ratio
Time frame: 1 year
ONSD/ETD (external transverse diameter) ratio and potential correlation with opening pressure.
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.
10 secondary outcomes
Optic disc elevation
Time frame: 1 year
ONSD diameter on MR c in patients with IIH
Time frame: 1 year
Changes in the optic nerve (ONSD)
Time frame: 1 month
Changes in the optic nerve (ONSD)
Time frame: 6 months
Changes in the optic nerve (ODE)
Time frame: 1 month
Changes in the optic nerve (ODE)
Time frame: 6 months
TCD (PI - pulsatility index) in patients with IIH
Time frame: 2 years
TCD (MBFV - mean blood flow velocity) in patients with IIH
Time frame: 2 years
TCD (RI - resistance index) in patients with IIH
Time frame: 2 years
Neuro-ophthalmological evaluation of papilledema versus ultrasound evaluation of the optic nerve
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rigmor Jensen, Dr.med. principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOS and TCD in people with Idiopathic Intracranial Hypertension, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between opening pressure and ONSD (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.