Intracranial HypertensionHYPERPICNCT04115553
Assessment of Venous Drainage in Idiopathic Intracranial Hypertension
A study testing MRI examination and ECG in people with Intracranial Hypertension, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Intracranial hypertension (IIH) is a disorder producing a syndrome of increased intracranial pressure secondary to a compressive intracranial lesion or said to be idiopathic. The most common symptoms are headaches, blindness, pulsatile tinnitus or papillary edema. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- MRI examination and ECG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2020to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age : >18 years old
- adult patients referred to the imaging department for intracranial hypertension assessment
- adult control subjects without history of cerebral or vascular pathology
Who cannot join
- history of cerebral or vascular pathology for the control subjects
- pregnant woman
- claustrophobia
- major obesity
- any contraindication to MRI exam
Trial locations and contacts
1 site in 1 country.
About this study
Intracranial hypertension (IIH) is a disorder producing a syndrome of increased intracranial pressure secondary to a compressive intracranial lesion or said to be idiopathic. The most common symptoms are headaches, blindness, pulsatile tinnitus or papillary edema. There are many options for the treatment of IIH, especially neurosurgery (derivation of cerebrospinal fluid or stent placement). Currently, idiopathic IIH has no clear etiology but the hypothesis of sino-venous insufficiency is more and more recognized. The assumption of venous insufficiency has not been demonstrated so far. Therefore the investigators propose to demonstrate that cerebral venous drainage pathways are altered in adult patients with idiopathic intracranial hypertension in comparison to healthy individuals having normal circulation. Assessment will be performed using Magnetic Resonance Imaging which is part of the patient care.
Read the detailed description
The investigator working hypothesis is an impairment of the cerebral venous drainage in IIH compared to the circulation observed in healthy volunteers considered as the reference. The research will focus on adult patients referred to the imaging department for intracranial hypertension assessment. MRI support is common for this type of request The reference will be established in a population of healthy volunteers for whom MRI blood flow measurements will be performed. In addition to the primary objective, the investigators assess the impact of IIH on CSF dynamics The study does not present any risk for the subject, any contraindication to MRI examination being respected. The subjects will undergo MRI examination including morphological and flow sequences without contrast injection. The flow sequences, in planes located at the C2-C3 and aqueductal levels, will be used to measure vascular flows (venous and arterial) and CSF oscillatory volumes. Image post-processing will be performed on a semi-automatic software allowing to extract fluid dynamics parameters.
- Conditions
- Intracranial Hypertension
- Being tested
- MRI examination, ECG
- Keywords
- Intracranial Hypertension, venous drainage, MRI, blood flow, cerebrospinal fluid flow
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationDiagnostic test
Also called Magnetic resonance imaging (MRI)
Subjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. Standard MRI examination using a 32-channel head coil consists of angiographic, morphological and phase-contrast 2D flow sequences. The flow planes are set perpendicularly to the structure axis (blood or CSF regions). The velocity measured in the pixels inside the region of interest allow the calculation of a mean flow rate as well as the volume displaced during a cardiac cycle.
ECGDiagnostic test
Also called Electrocardiogram
A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.
| Study group | Role | What they receive |
|---|---|---|
| idiopathic intracranial hypertension | Experimental | patients with idiopathic intracranial hypertension Receives: Diagnostic Test: MRI examination; Diagnostic Test: ECG |
| healthy subjects | Sham comparator | Healthy subjects Receives: Diagnostic Test: MRI examination; Diagnostic Test: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio between jugular vein flow and total arterial brain flow.
Venous jugular flow is the sum right and left internal jugular vein flows. Total arterial flow is the sum of right and left internal carotid and vertebral arteries flows.
Measured: day 0 = day of inclusion
Secondary outcomes (1)
CSF (cerebrospinal fluid) Stroke volumes
CSF oscillatory volumes measured at the Sylvius' aqueduct and sub-arachnoidian space levels
Measured: day 0 = day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start19 Feb 2020
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115553
- Sponsor's protocol ID
- PI2019_843_0056
- Acronym
- HYPERPIC
- Status last verified
- Jun 2025
- First submitted
- 3 Oct 2019
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Venous Drainage in Idiopathic Intracranial Hypertension
- ClinicalTrials.gov ID
- NCT04115553
- Acronym / sponsor ID
- HYPERPIC / PI2019_843_0056
- Conditions
- Intracranial Hypertension
- Keywords
- Intracranial Hypertension, venous drainage, MRI, blood flow, cerebrospinal fluid flow
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 4 Oct 2019 (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.
Intracranial hypertension (IIH) is a disorder producing a syndrome of increased intracranial pressure secondary to a compressive intracranial lesion or said to be idiopathic. The most common symptoms are headaches, blindness, pulsatile tinnitus or papillary edema. There are many options for the treatment of IIH, especially neurosurgery (derivation of cerebrospinal fluid or stent placement). Currently, idiopathic IIH has no clear etiology but the hypothesis of sino-venous insufficiency is more and more recognized. The assumption of venous insufficiency has not been demonstrated so far. Therefore the investigators propose to demonstrate that cerebral venous drainage pathways are altered in adult patients with idiopathic intracranial hypertension in comparison to healthy individuals having normal circulation. Assessment will be performed using Magnetic Resonance Imaging which is part of the patient care.
Detailed description
The investigator working hypothesis is an impairment of the cerebral venous drainage in IIH compared to the circulation observed in healthy volunteers considered as the reference. The research will focus on adult patients referred to the imaging department for intracranial hypertension assessment. MRI support is common for this type of request The reference will be established in a population of healthy volunteers for whom MRI blood flow measurements will be performed. In addition to the primary objective, the investigators assess the impact of IIH on CSF dynamics The study does not present any risk for the subject, any contraindication to MRI examination being respected. The subjects will undergo MRI examination including morphological and flow sequences without contrast injection. The flow sequences, in planes located at the C2-C3 and aqueductal levels, will be used to measure vascular flows (venous and arterial) and CSF oscillatory volumes. Image post-processing will be performed on a semi-automatic software allowing to extract fluid dynamics parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| idiopathic intracranial hypertension | Experimental | Diagnostic Test: MRI examination, Diagnostic Test: ECGpatients with idiopathic intracranial hypertension |
| healthy subjects | Sham comparator | Diagnostic Test: MRI examination, Diagnostic Test: ECGHealthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age : >18 years old
- adult patients referred to the imaging department for intracranial hypertension assessment
- adult control subjects without history of cerebral or vascular pathology
Key exclusion criteria (5 listed)
- history of cerebral or vascular pathology for the control subjects
- pregnant woman
- claustrophobia
- major obesity
- any contraindication to MRI exam
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 |
|---|---|---|
| MRI examinationAlso: Magnetic resonance imaging (MRI)Subjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. Standard MRI examination using a 32-channel head coil consists of angiographic, morphological and phase-contrast 2D flow sequences. The flow planes are set perpendicularly to the structure axis (blood or CSF regions). The velocity measured in the pixels inside the region of interest allow the calculation of a mean flow rate as well as the volume displaced during a cardiac cycle. | Diagnostic test | healthy subjects, idiopathic intracranial hypertension |
| ECGAlso: ElectrocardiogramA cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate. | Diagnostic test | healthy subjects, idiopathic intracranial hypertension |
Primary outcome
Ratio between jugular vein flow and total arterial brain flow.
Time frame: day 0 = day of inclusion
Venous jugular flow is the sum right and left internal jugular vein flows. Total arterial flow is the sum of right and left internal carotid and vertebral arteries flows.
1 secondary outcome
CSF (cerebrospinal fluid) Stroke volumes
Time frame: day 0 = day of inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI examination and ECG in people with Intracranial Hypertension, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. 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 France. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Ratio between jugular vein flow and total arterial brain flow. (time frame: day 0 = day of inclusion). 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 10 Jun 2025.