Idiopathic Intracranial HypertensionNCT07915453
Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension
An observational study of Idiopathic Intracranial Hypertension, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Idiopathic intracranial hypertension (IIH) is a neurological disorder characterized by increased pressure inside the skull without an identifiable cause. It can lead to headaches, swelling of the optic nerve, and visual impairment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Intracranial Hypertension
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to Aug 2028
- Phase
- Observational
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This single-center prospective observational study will enroll 105 participants, including 65 patients with idiopathic intracranial hypertension (IIH) and 40 healthy controls. Patients with IIH will be recruited at Beijing Tiantan Hospital. Healthy controls will be selected for comparison based on age, sex, and body mass index. Patients with IIH will undergo baseline and follow-up assessments, while healthy controls will undergo baseline assessments only.
Who may be able to join
- Patients with Idiopathic Intracranial Hypertension (IIH):
- Aged 18-60 years.
- Clinical manifestations consistent with or highly suggestive of IIH, such as headache, visual disturbance, papilledema, pulsatile tinnitus, or diplopia.
- No hydrocephalus, intracranial mass, or other structural cause of increased intracranial pressure on CT or MRI.
- Normal cerebrospinal fluid composition.
- Lumbar puncture opening pressure ≥250 mmH₂O.
Show all 16Show fewer
- Ability to complete standardized baseline MRI examinations.
- Provision of written informed consent.
- Healthy Controls:
- Aged 18-60 years.
- Comparable age, sex, and body mass index to the IIH group.
- No history of IIH or symptoms suggestive of increased intracranial pressure.
- No papilledema or significant visual or neuro-ophthalmological abnormalities.
- No history of major neurological disorders.
- Ability to complete standardized multimodal MRI examinations.
- Provision of written informed consent.
Who cannot join
- Patients with IIH:
- Secondary intracranial hypertension due to cerebral venous sinus thrombosis, intracranial infection, mass lesions, hydrocephalus, or other identifiable causes.
- Previous surgical or endovascular procedures substantially affecting intracranial pressure or cerebral venous drainage.
- Ophthalmological or neuro-ophthalmological disorders that may interfere with visual assessment.
- Recent head trauma or intracranial surgery, major brain abnormalities, or neurological disorders that may substantially affect MRI assessments; long-term use of medications considered likely to interfere with intracranial pressure or fluid metabolism.
- Pregnancy or breastfeeding.
Show all 16Show fewer
- Severe systemic illness or MRI contraindications.
- Inadequate baseline MRI quality or substantial missing clinical data preventing reliable analysis.
- Any other condition considered unsuitable for participation by the investigator.
- Healthy Controls:
- History of IIH, cerebral venous disorders, intracranial mass lesions, hydrocephalus, or other neurological conditions potentially affecting brain fluid dynamics.
- Ophthalmological or neuro-ophthalmological disorders that may interfere with visual assessment.
- Pregnancy or breastfeeding.
- MRI contraindications.
- Severe systemic illness preventing completion of study examinations.
- Any other condition considered unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: A Clinical Study Using Multimodal MRI to Evaluate the Effects of Choroid Plexus Function, Glymphatic Function, and Blood-Brain Barrier Function on Cerebrospinal Fluid Circulation in Patients With Idiopathic Intracranial Hypertension
Idiopathic intracranial hypertension (IIH) is a neurological disorder characterized by increased pressure inside the skull without an identifiable cause. It can lead to headaches, swelling of the optic nerve, and visual impairment. Alterations in cerebrospinal fluid circulation and fluid exchange within the brain may contribute to this condition, but the underlying mechanisms remain incompletely understood.
This prospective observational study aims to investigate brain fluid circulation in patients with IIH using multimodal magnetic resonance imaging (MRI).A total of 105 participants will be enrolled, including 65 patients with IIH and 40 healthy controls. Healthy controls will be recruited to achieve comparable distributions of age, sex, and body mass index at the group level.
Read more
The primary objective is to compare MRI measures related to the choroid plexus, cerebrospinal fluid flow, glymphatic function, cerebral perfusion, and water exchange across the blood-brain barrier between patients with IIH and healthy controls. Secondary objectives are to assess changes in these measures after clinical treatment and examine their associations with intracranial pressure, optic nerve swelling, visual function, and clinical symptoms.
Patients with IIH will undergo clinical, ophthalmological, and MRI assessments at baseline and approximately 3 and 6 months after treatment. Healthy controls will undergo baseline assessments only.
This study will not assign treatments. All clinical management decisions will be made independently by treating physicians. Research MRI examinations will not require contrast agents, and no invasive procedures will be performed solely for research purposes.
Read the detailed description
This is a single-center, prospective observational study designed to characterize brain fluid circulation-related abnormalities in patients with idiopathic intracranial hypertension (IIH) through multimodal MRI and to investigate their clinical relevance and longitudinal changes following routine clinical treatment.
A total of 105 participants will be enrolled, including 65 patients with IIH and 40 healthy controls. Healthy controls will be recruited to achieve comparable distributions of age, sex, and body mass index at the group level. Baseline comparisons will assess differences in imaging markers representing several complementary aspects of brain fluid homeostasis.
Multimodal MRI examinations will include structural T1- and T2-weighted imaging, magnetic resonance venography, phase-contrast MRI, diffusion MRI, resting-state functional MRI, arterial spin labeling, and vascular water exchange imaging (VEXI).
The imaging assessment will include choroid plexus volume, cerebral aqueduct cerebrospinal fluid flow parameters, perivascular space burden, diffusion tensor imaging analysis along the perivascular space (DTI-ALPS) index, free-water fraction, diffusion tensor imaging-estimated periventricular diffusivity (DTI-EstPVeD), global blood oxygen level-dependent signal-cerebrospinal fluid coupling, cerebral blood flow, and the apparent water exchange rate across the blood-brain barrier (AXR_BBB).
Clinical evaluations in patients with IIH will include cerebrospinal fluid opening pressure, visual acuity, visual field mean deviation, Frisén papilledema grade, retinal nerve fiber layer thickness, and standardized assessments of headache, tinnitus, quality of life, and cognitive function. Trans-stenotic pressure gradients and other invasive clinical measurements will be recorded when available from clinically indicated procedures.
Patients with IIH will undergo repeated clinical, ophthalmological, and multimodal MRI assessments at baseline, 90 ± 14 days, and 180 ± 30 days after clinical treatment. Healthy controls will undergo baseline assessments only. Treatment, including medical management or venous sinus stenting when clinically indicated, will be determined independently by treating physicians and will not be assigned by the study protocol.
The primary analysis will compare baseline imaging measures between patients with IIH and healthy controls, adjusting for age, sex, and body mass index. Longitudinal analyses will evaluate within-patient changes in imaging measures and their associations with changes in intracranial pressure, papilledema, visual function, and clinical symptoms. Comparisons between treatment subgroups will be considered exploratory because treatment allocation is not randomized.
The study aims to provide a comprehensive multimodal imaging characterization of brain fluid circulation-related abnormalities in IIH and to identify potential imaging markers for future disease assessment and treatment monitoring.
- Conditions
- Idiopathic Intracranial Hypertension
- Keywords
- Idiopathic Intracranial Hypertension, Choroid Plexus, Glymphatic System, Blood-Brain Barrier, Cerebrospinal Fluid Dynamics, Multimodal Magnetic Resonance Imaging, DTI-ALPS, Perivascular Spaces
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IIH Patients | Sixty-five patients with idiopathic intracranial hypertension (IIH) will undergo baseline clinical, ophthalmological, and multimodal MRI assessments. Follow-up assessments will be performed at 90 ± 14 days and 180 ± 30 days after clinical treatment. Treatment, including medical management or venous sinus stenting when clinically indicated, will be determined independently by treating physicians and will not be assigned by the study protocol. | |
| Healthy Controls | Forty healthy controls will be recruited to achieve comparable distributions of age, sex, and body mass index to those of the IIH group at the group level. Healthy controls will undergo baseline demographic assessment, noninvasive screening, and multimodal MRI only. No longitudinal follow-up or study-related invasive procedures will be performed in healthy controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Choroid Plexus Volume
Total bilateral choroid plexus volume (mm³) measured using structural MRI.
Measured: Baseline
Whole-Brain-Normalized Choroid Plexus Volume
Choroid plexus volume normalized to whole-brain volume, expressed as a dimensionless ratio.
Measured: Baseline
Peak Systolic Cerebrospinal Fluid Velocity in the Cerebral Aqueduct
Peak systolic cerebrospinal fluid velocity (cm/s) in the cerebral aqueduct measured using phase-contrast MRI.
Measured: Baseline
Peak Diastolic Cerebrospinal Fluid Velocity in the Cerebral Aqueduct
Peak diastolic cerebrospinal fluid velocity (cm/s) in the cerebral aqueduct measured using phase-contrast MRI.
Measured: Baseline
Mean Cerebrospinal Fluid Velocity in the Cerebral Aqueduct
Mean cerebrospinal fluid velocity (cm/s) in the cerebral aqueduct measured using phase-contrast MRI.
Measured: Baseline
Net Cerebrospinal Fluid Flow Rate Through the Cerebral Aqueduct
Net cerebrospinal fluid flow rate (mL/min) through the cerebral aqueduct measured using cardiac-gated phase-contrast MRI.
Measured: Baseline
Total Perivascular Space Volume Fraction
Ratio of MRI-visible perivascular space volume to intracranial volume, derived from structural MRI.
Measured: Baseline
Overall Diffusion Tensor Imaging Along the Perivascular Space Index
Overall diffusion tensor imaging along the perivascular space (DTI-ALPS) index derived from diffusion MRI, expressed as a dimensionless ratio.
Measured: Baseline
White Matter Free-Water Fraction
Extracellular free-water fraction in cerebral white matter estimated using diffusion MRI.
Measured: Baseline
Diffusion Tensor Imaging-Estimated Periventricular Diffusivity Index
Periventricular diffusivity (PVeD) index estimated from the transverse tensor ratio (TTR) in periventricular white matter using diffusion tensor MRI.
Measured: Baseline
Global Blood Oxygen Level-Dependent Signal-Cerebrospinal Fluid Coupling
Pearson correlation coefficient (r) between the global gray-matter BOLD signal and the CSF inflow signal derived from resting-state functional MRI.
Measured: Baseline
Whole-Brain Cerebral Blood Flow
Mean whole-brain cerebral blood flow (mL/100 g/min) measured using arterial spin labeling MRI.
Measured: Baseline
Gray Matter Cerebral Blood Flow
Mean cerebral blood flow (mL/100 g/min) in gray matter measured using arterial spin labeling MRI.
Measured: Baseline
White Matter Cerebral Blood Flow
Mean cerebral blood flow (mL/100 g/min) in white matter measured using arterial spin labeling MRI.
Measured: Baseline
White Matter Apparent Blood-Brain Barrier Water Exchange Rate
Apparent blood-brain barrier water exchange rate (AXR_BBB) in cerebral white matter estimated using vascular water exchange imaging (VEXI).
Measured: Baseline
Deep Gray Matter Apparent Blood-Brain Barrier Water Exchange Rate
Apparent blood-brain barrier water exchange rate (AXR_BBB) in deep gray matter estimated using vascular water exchange imaging (VEXI).
Measured: Baseline
Secondary outcomes (16)
Cerebrospinal Fluid Opening Pressure
Cerebrospinal fluid opening pressure (mmH₂O) measured during clinically indicated lumbar puncture in patients with IIH.
Measured: Baseline
Trans-Stenotic Venous Pressure Gradient
Pressure gradient (mmHg) across venous sinus stenosis measured during clinically indicated venous manometry in patients with IIH.
Measured: Baseline
Visual Acuity
Visual acuity recorded as a numerical measure during ophthalmological examination in patients with IIH.
Measured: Baseline
Visual Field Mean Deviation
Visual field mean deviation (dB) measured using automated perimetry in patients with IIH.
Measured: Baseline
Frisén Papilledema Grade
Papilledema severity assessed using the Frisén grading scale (0-5), with higher grades indicating greater severity.
Measured: Baseline
Retinal Nerve Fiber Layer Thickness
Retinal nerve fiber layer thickness (µm) measured using optical coherence tomography.
Measured: Baseline
Headache Impact Test-6 Score
Total score on the six-item Headache Impact Test (HIT-6), ranging from 36 to 78, with higher scores indicating greater headache-related impact.
Measured: Baseline
Tinnitus Handicap Inventory Score
Total score on the Tinnitus Handicap Inventory (THI), ranging from 0 to 100, with higher scores indicating greater tinnitus-related handicap.
Measured: Baseline
EuroQol 5-Dimension Index Score
Health-related quality of life measured using the EQ-5D index value, with higher scores indicating better health status.
Measured: Baseline
Mini-Mental State Examination Score
Total score on the Mini-Mental State Examination (MMSE), ranging from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline
Montreal Cognitive Assessment Score
Total score on the Montreal Cognitive Assessment (MoCA), ranging from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline
Oral Symbol Digit Modalities Test Score
Number of correct responses on the Oral Symbol Digit Modalities Test (Oral SDMT), with higher scores indicating better information processing speed.
Measured: Baseline
Trail Making Test Part A Completion Time
Completion time (seconds) for the Trail Making Test Part A (TMT-A), with longer times indicating slower performance.
Measured: Baseline
Trail Making Test Part B Completion Time
Completion time (seconds) for the Trail Making Test Part B (TMT-B), with longer times indicating slower performance.
Measured: Baseline
Stroop Color-Word Interference Completion Time
Completion time (seconds) for the interference condition of the Stroop Color-Word Test, with longer times indicating poorer performance.
Measured: Baseline
Backward Digit Span Score
Number of digit sequences correctly recalled in reverse order, with higher scores indicating better working memory performance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
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.
- More trials run by Beijing Tiantan HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dapeng Mo, Beijing Tiantan Hospital
- Investigators
- Dapeng Mo, PhD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915453
- Sponsor's protocol ID
- HX-B-2026054
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Using Multimodal MRI to Evaluate the Effects of Choroid Plexus Function, Glymphatic Function, and Blood-Brain Barrier Function on Cerebrospinal Fluid Circulation in Patients With Idiopathic Intracranial Hypertension
- ClinicalTrials.gov ID
- NCT07915453
- Acronym / sponsor ID
- HX-B-2026054
- Conditions
- Idiopathic Intracranial Hypertension
- Keywords
- Idiopathic Intracranial Hypertension, Choroid Plexus, Glymphatic System, Blood-Brain Barrier, Cerebrospinal Fluid Dynamics, Multimodal Magnetic Resonance Imaging, DTI-ALPS, Perivascular Spaces
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 4 Nov 2026 (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 neurological disorder characterized by increased pressure inside the skull without an identifiable cause. It can lead to headaches, swelling of the optic nerve, and visual impairment. Alterations in cerebrospinal fluid circulation and fluid exchange within the brain may contribute to this condition, but the underlying mechanisms remain incompletely understood.
This prospective observational study aims to investigate brain fluid circulation in patients with IIH using multimodal magnetic resonance imaging (MRI).A total of 105 participants will be enrolled, including 65 patients with IIH and 40 healthy controls. Healthy controls will be recruited to achieve comparable distributions of age, sex, and body mass index at the group level.
The primary objective is to compare MRI measures related to the choroid plexus, cerebrospinal fluid flow, glymphatic function, cerebral perfusion, and water exchange across the blood-brain barrier between patients with IIH and healthy controls. Secondary objectives are to assess changes in these measures after clinical treatment and examine their associations with intracranial pressure, optic nerve swelling, visual function, and clinical symptoms.
Patients with IIH will undergo clinical, ophthalmological, and MRI assessments at baseline and approximately 3 and 6 months after treatment. Healthy controls will undergo baseline assessments only.
This study will not assign treatments. All clinical management decisions will be made independently by treating physicians. Research MRI examinations will not require contrast agents, and no invasive procedures will be performed solely for research purposes.
Detailed description
This is a single-center, prospective observational study designed to characterize brain fluid circulation-related abnormalities in patients with idiopathic intracranial hypertension (IIH) through multimodal MRI and to investigate their clinical relevance and longitudinal changes following routine clinical treatment.
A total of 105 participants will be enrolled, including 65 patients with IIH and 40 healthy controls. Healthy controls will be recruited to achieve comparable distributions of age, sex, and body mass index at the group level. Baseline comparisons will assess differences in imaging markers representing several complementary aspects of brain fluid homeostasis.
Multimodal MRI examinations will include structural T1- and T2-weighted imaging, magnetic resonance venography, phase-contrast MRI, diffusion MRI, resting-state functional MRI, arterial spin labeling, and vascular water exchange imaging (VEXI).
The imaging assessment will include choroid plexus volume, cerebral aqueduct cerebrospinal fluid flow parameters, perivascular space burden, diffusion tensor imaging analysis along the perivascular space (DTI-ALPS) index, free-water fraction, diffusion tensor imaging-estimated periventricular diffusivity (DTI-EstPVeD), global blood oxygen level-dependent signal-cerebrospinal fluid coupling, cerebral blood flow, and the apparent water exchange rate across the blood-brain barrier (AXR_BBB).
Clinical evaluations in patients with IIH will include cerebrospinal fluid opening pressure, visual acuity, visual field mean deviation, Frisén papilledema grade, retinal nerve fiber layer thickness, and standardized assessments of headache, tinnitus, quality of life, and cognitive function. Trans-stenotic pressure gradients and other invasive clinical measurements will be recorded when available from clinically indicated procedures.
Patients with IIH will undergo repeated clinical, ophthalmological, and multimodal MRI assessments at baseline, 90 ± 14 days, and 180 ± 30 days after clinical treatment. Healthy controls will undergo baseline assessments only. Treatment, including medical management or venous sinus stenting when clinically indicated, will be determined independently by treating physicians and will not be assigned by the study protocol.
The primary analysis will compare baseline imaging measures between patients with IIH and healthy controls, adjusting for age, sex, and body mass index. Longitudinal analyses will evaluate within-patient changes in imaging measures and their associations with changes in intracranial pressure, papilledema, visual function, and clinical symptoms. Comparisons between treatment subgroups will be considered exploratory because treatment allocation is not randomized.
The study aims to provide a comprehensive multimodal imaging characterization of brain fluid circulation-related abnormalities in IIH and to identify potential imaging markers for future disease assessment and treatment monitoring.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IIH Patients | – | –Sixty-five patients with idiopathic intracranial hypertension (IIH) will undergo baseline clinical, ophthalmological, and multimodal MRI assessments. Follow-up assessments will be performed at 90 ± 14 days and 180 ± 30 days after clinical treatment. Treatment, including medical management or venous sinus stenting when clinically indicated, will be determined independently by treating physicians and will not be assigned by the study protocol. |
| Healthy Controls | – | –Forty healthy controls will be recruited to achieve comparable distributions of age, sex, and body mass index to those of the IIH group at the group level. Healthy controls will undergo baseline demographic assessment, noninvasive screening, and multimodal MRI only. No longitudinal follow-up or study-related invasive procedures will be performed in healthy controls. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This single-center prospective observational study will enroll 105 participants, including 65 patients with idiopathic intracranial hypertension (IIH) and 40 healthy controls. Patients with IIH will be recruited at Beijing Tiantan Hospital. Healthy controls will be selected for comparison based on age, sex, and body mass index. Patients with IIH will undergo baseline and follow-up assessments, while healthy controls will undergo baseline assessments only.
Key inclusion criteria (16 listed)
- Aged 18-60 years.
- Clinical manifestations consistent with or highly suggestive of IIH, such as headache, visual disturbance, papilledema, pulsatile tinnitus, or diplopia.
- No hydrocephalus, intracranial mass, or other structural cause of increased intracranial pressure on CT or MRI.
- Normal cerebrospinal fluid composition.
- Lumbar puncture opening pressure ≥250 mmH₂O.
Key exclusion criteria (16 listed)
- Secondary intracranial hypertension due to cerebral venous sinus thrombosis, intracranial infection, mass lesions, hydrocephalus, or other identifiable causes.
- Previous surgical or endovascular procedures substantially affecting intracranial pressure or cerebral venous drainage.
- Ophthalmological or neuro-ophthalmological disorders that may interfere with visual assessment.
- Recent head trauma or intracranial surgery, major brain abnormalities, or neurological disorders that may substantially affect MRI assessments; long-term use of medications considered likely to interfere with intracranial pressure or fluid metabolism.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Choroid Plexus Volume
Time frame: Baseline
Total bilateral choroid plexus volume (mm³) measured using structural MRI.
Whole-Brain-Normalized Choroid Plexus Volume
Time frame: Baseline
Choroid plexus volume normalized to whole-brain volume, expressed as a dimensionless ratio.
Peak Systolic Cerebrospinal Fluid Velocity in the Cerebral Aqueduct
Time frame: Baseline
Peak systolic cerebrospinal fluid velocity (cm/s) in the cerebral aqueduct measured using phase-contrast MRI.
Peak Diastolic Cerebrospinal Fluid Velocity in the Cerebral Aqueduct
Time frame: Baseline
Peak diastolic cerebrospinal fluid velocity (cm/s) in the cerebral aqueduct measured using phase-contrast MRI.
Mean Cerebrospinal Fluid Velocity in the Cerebral Aqueduct
Time frame: Baseline
Mean cerebrospinal fluid velocity (cm/s) in the cerebral aqueduct measured using phase-contrast MRI.
Net Cerebrospinal Fluid Flow Rate Through the Cerebral Aqueduct
Time frame: Baseline
Net cerebrospinal fluid flow rate (mL/min) through the cerebral aqueduct measured using cardiac-gated phase-contrast MRI.
Total Perivascular Space Volume Fraction
Time frame: Baseline
Ratio of MRI-visible perivascular space volume to intracranial volume, derived from structural MRI.
Overall Diffusion Tensor Imaging Along the Perivascular Space Index
Time frame: Baseline
Overall diffusion tensor imaging along the perivascular space (DTI-ALPS) index derived from diffusion MRI, expressed as a dimensionless ratio.
White Matter Free-Water Fraction
Time frame: Baseline
Extracellular free-water fraction in cerebral white matter estimated using diffusion MRI.
Diffusion Tensor Imaging-Estimated Periventricular Diffusivity Index
Time frame: Baseline
Periventricular diffusivity (PVeD) index estimated from the transverse tensor ratio (TTR) in periventricular white matter using diffusion tensor MRI.
Global Blood Oxygen Level-Dependent Signal-Cerebrospinal Fluid Coupling
Time frame: Baseline
Pearson correlation coefficient (r) between the global gray-matter BOLD signal and the CSF inflow signal derived from resting-state functional MRI.
Whole-Brain Cerebral Blood Flow
Time frame: Baseline
Mean whole-brain cerebral blood flow (mL/100 g/min) measured using arterial spin labeling MRI.
Gray Matter Cerebral Blood Flow
Time frame: Baseline
Mean cerebral blood flow (mL/100 g/min) in gray matter measured using arterial spin labeling MRI.
White Matter Cerebral Blood Flow
Time frame: Baseline
Mean cerebral blood flow (mL/100 g/min) in white matter measured using arterial spin labeling MRI.
White Matter Apparent Blood-Brain Barrier Water Exchange Rate
Time frame: Baseline
Apparent blood-brain barrier water exchange rate (AXR_BBB) in cerebral white matter estimated using vascular water exchange imaging (VEXI).
Deep Gray Matter Apparent Blood-Brain Barrier Water Exchange Rate
Time frame: Baseline
Apparent blood-brain barrier water exchange rate (AXR_BBB) in deep gray matter estimated using vascular water exchange imaging (VEXI).
16 secondary outcomes
Cerebrospinal Fluid Opening Pressure
Time frame: Baseline
Trans-Stenotic Venous Pressure Gradient
Time frame: Baseline
Visual Acuity
Time frame: Baseline
Visual Field Mean Deviation
Time frame: Baseline
Frisén Papilledema Grade
Time frame: Baseline
Retinal Nerve Fiber Layer Thickness
Time frame: Baseline
Headache Impact Test-6 Score
Time frame: Baseline
Tinnitus Handicap Inventory Score
Time frame: Baseline
EuroQol 5-Dimension Index Score
Time frame: Baseline
Mini-Mental State Examination Score
Time frame: Baseline
Montreal Cognitive Assessment Score
Time frame: Baseline
Oral Symbol Digit Modalities Test Score
Time frame: Baseline
Trail Making Test Part A Completion Time
Time frame: Baseline
Trail Making Test Part B Completion Time
Time frame: Baseline
Stroop Color-Word Interference Completion Time
Time frame: Baseline
Backward Digit Span Score
Time frame: Baseline
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 4 Nov 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data outside the study team.
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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.
Dapeng Mo, PhD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Intracranial Hypertension, run by Beijing Tiantan Hospital at 1 site in China.
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 16 inclusion and 16 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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 China. 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?
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?
Contact Dapeng Mo, PhD (18811039300, bjttmodp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Choroid Plexus Volume (time frame: Baseline). The study lists 16 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 4 Nov 2026.