Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension

October 29, 2026 updated by: Dapeng Mo, Beijing Tiantan Hospital

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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.

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.

Exclusion Criteria:

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_CONTROL
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Choroid Plexus Volume
Time Frame: Baseline

Total bilateral choroid plexus volume (mm³) measured using structural MRI.
Baseline
Whole-Brain-Normalized Choroid Plexus Volume
Time Frame: Baseline

Choroid plexus volume normalized to whole-brain volume, expressed as a dimensionless ratio.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
Total Perivascular Space Volume Fraction
Time Frame: Baseline

Ratio of MRI-visible perivascular space volume to intracranial volume, derived from structural MRI.
Baseline
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.
Baseline
White Matter Free-Water Fraction
Time Frame: Baseline

Extracellular free-water fraction in cerebral white matter estimated using diffusion MRI.
Baseline
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.
Baseline
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.
Baseline
Whole-Brain Cerebral Blood Flow
Time Frame: Baseline

Mean whole-brain cerebral blood flow (mL/100 g/min) measured using arterial spin labeling MRI.
Baseline
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.
Baseline
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.
Baseline
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).
Baseline
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).
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cerebrospinal Fluid Opening Pressure
Time Frame: Baseline

Cerebrospinal fluid opening pressure (mmH₂O) measured during clinically indicated lumbar puncture in patients with IIH.
Baseline
Trans-Stenotic Venous Pressure Gradient
Time Frame: Baseline

Pressure gradient (mmHg) across venous sinus stenosis measured during clinically indicated venous manometry in patients with IIH.
Baseline
Visual Acuity
Time Frame: Baseline

Visual acuity recorded as a numerical measure during ophthalmological examination in patients with IIH.
Baseline
Visual Field Mean Deviation
Time Frame: Baseline

Visual field mean deviation (dB) measured using automated perimetry in patients with IIH.
Baseline
Frisén Papilledema Grade
Time Frame: Baseline

Papilledema severity assessed using the Frisén grading scale (0-5), with higher grades indicating greater severity.
Baseline
Retinal Nerve Fiber Layer Thickness
Time Frame: Baseline

Retinal nerve fiber layer thickness (µm) measured using optical coherence tomography.
Baseline
Headache Impact Test-6 Score
Time Frame: Baseline

Total score on the six-item Headache Impact Test (HIT-6), ranging from 36 to 78, with higher scores indicating greater headache-related impact.
Baseline
Tinnitus Handicap Inventory Score
Time Frame: Baseline

Total score on the Tinnitus Handicap Inventory (THI), ranging from 0 to 100, with higher scores indicating greater tinnitus-related handicap.
Baseline
EuroQol 5-Dimension Index Score
Time Frame: Baseline

Health-related quality of life measured using the EQ-5D index value, with higher scores indicating better health status.
Baseline
Mini-Mental State Examination Score
Time Frame: Baseline

Total score on the Mini-Mental State Examination (MMSE), ranging from 0 to 30, with higher scores indicating better cognitive performance.
Baseline
Montreal Cognitive Assessment Score
Time Frame: Baseline

Total score on the Montreal Cognitive Assessment (MoCA), ranging from 0 to 30, with higher scores indicating better cognitive performance.
Baseline
Oral Symbol Digit Modalities Test Score
Time Frame: Baseline

Number of correct responses on the Oral Symbol Digit Modalities Test (Oral SDMT), with higher scores indicating better information processing speed.
Baseline
Trail Making Test Part A Completion Time
Time Frame: Baseline

Completion time (seconds) for the Trail Making Test Part A (TMT-A), with longer times indicating slower performance.
Baseline
Trail Making Test Part B Completion Time
Time Frame: Baseline

Completion time (seconds) for the Trail Making Test Part B (TMT-B), with longer times indicating slower performance.
Baseline
Stroop Color-Word Interference Completion Time
Time Frame: Baseline

Completion time (seconds) for the interference condition of the Stroop Color-Word Test, with longer times indicating poorer performance.
Baseline
Backward Digit Span Score
Time Frame: Baseline

Number of digit sequences correctly recalled in reverse order, with higher scores indicating better working memory performance.
Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Whole-Brain-Normalized Choroid Plexus Volume
Time Frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Change from baseline in choroid plexus volume normalized to whole-brain volume, measured using structural MRI.
Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Net Cerebrospinal Fluid Flow Rate Through the Cerebral Aqueduct
Time Frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Change from baseline in net cerebrospinal fluid flow rate (mL/min) through the cerebral aqueduct measured using phase-contrast MRI.
Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Total Perivascular Space Volume Fraction
Time Frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Change from baseline in the ratio of MRI-visible perivascular space volume to intracranial volume.
Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Overall DTI-ALPS Index
Time Frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Change from baseline in the overall DTI-ALPS index derived from diffusion MRI.
Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in White Matter Free-Water Fraction
Time Frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Change from baseline in white matter extracellular free-water fraction estimated using diffusion MRI.
Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Global BOLD-CSF Coupling
Time Frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Change from baseline in the Pearson correlation coefficient between the global gray-matter BOLD signal and the CSF inflow signal.
Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Whole-Brain Cerebral Blood Flow
Time Frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Change from baseline in mean whole-brain cerebral blood flow (mL/100 g/min) measured using arterial spin labeling MRI.
Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in White Matter Apparent Blood-Brain Barrier Water Exchange Rate
Time Frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Change from baseline in apparent blood-brain barrier water exchange rate in white matter estimated using VEXI.
Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Frisén Papilledema Grade
Time Frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Change from baseline in papilledema severity assessed using the Frisén grading scale (0-5).
Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Visual Field Mean Deviation
Time Frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Change from baseline in visual field mean deviation (dB) measured using automated perimetry.
Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dapeng Mo, PhD, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HX-B-2026054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is currently no plan to share individual participant data outside the study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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