Back to resultsAssessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler
Primary Purpose
Idiopathic Intracranial Hypertension
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
TOS and TCD
Sponsored by
About this trial
This is an interventional diagnostic trial for Idiopathic Intracranial Hypertension
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
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients suspected of IIH at baseline
Arm Description
Intervention: TOS and TCD measurements at baseline, and at routine follow-ups. Healthy controls will be recruited to match the patients.
Outcomes
Primary Outcome Measures
Correlation between opening pressure and ONSD
Optic nerve sheath diameter (ONSD) potential correlation with opening pressure.
Correlaton between opening pressure and ONSD/ETD ratio
ONSD/ETD (external transverse diameter) ratio and potential correlation with opening pressure.
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.
Secondary Outcome Measures
Optic disc elevation
Optic disc elevation measured by ultrasound in IIH compared with healthy controls
ONSD diameter on MR c in patients with IIH
ONSD and correlation with ONSD on orbital MRI.
Changes in the optic nerve (ONSD)
Changes in ONSD after 1 month
Changes in the optic nerve (ONSD)
Changes in ONSD after 6 months
Changes in the optic nerve (ODE)
Changes in ODE (optic disc elevation) after 1 month
Changes in the optic nerve (ODE)
Changes in ODE(optic disc elevation) after 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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04314128
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Intracranial Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, prospective cohort study with healthy controls.
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients suspected of IIH at baseline
Arm Type
Other
Arm Description
Intervention: TOS and TCD measurements at baseline, and at routine follow-ups.
Healthy controls will be recruited to match the patients.
Intervention Type
Diagnostic Test
Intervention Name(s)
TOS and TCD
Intervention Description
TOS: Transorbital sonography TCD: Transcranial Doppler
Primary Outcome Measure Information:
Title
Correlation between opening pressure and ONSD
Description
Optic nerve sheath diameter (ONSD) potential correlation with opening pressure.
Time Frame
1 year
Title
Correlaton between opening pressure and ONSD/ETD ratio
Description
ONSD/ETD (external transverse diameter) ratio and potential correlation with opening pressure.
Time Frame
1 year
Title
Comparison of ONSD in IIH and healthy controls
Description
Comparison of ONSD in patients with elevated ICP (IIH) and healthy controls, age- sex and BMI matched.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Optic disc elevation
Description
Optic disc elevation measured by ultrasound in IIH compared with healthy controls
Time Frame
1 year
Title
ONSD diameter on MR c in patients with IIH
Description
ONSD and correlation with ONSD on orbital MRI.
Time Frame
1 year
Title
Changes in the optic nerve (ONSD)
Description
Changes in ONSD after 1 month
Time Frame
1 month
Title
Changes in the optic nerve (ONSD)
Description
Changes in ONSD after 6 months
Time Frame
6 months
Title
Changes in the optic nerve (ODE)
Description
Changes in ODE (optic disc elevation) after 1 month
Time Frame
1 month
Title
Changes in the optic nerve (ODE)
Description
Changes in ODE(optic disc elevation) after 6 months
Time Frame
6 months
Title
TCD (PI - pulsatility index) in patients with IIH
Description
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
Title
TCD (MBFV - mean blood flow velocity) in patients with IIH
Description
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
Title
TCD (RI - resistance index) in patients with IIH
Description
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
Title
Neuro-ophthalmological evaluation of papilledema versus ultrasound evaluation of the optic nerve
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rigmor Jensen, Dr.med.
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
State/Province
Region Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler
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