An observational study in Idiopathic Intracranial Hypertension, sponsored by Beijing Tiantan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Beijing Tiantan Hospital · Observational
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.
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.
53 studies on the registry are indexed under Pseudotumor Cerebri; 22 are open to participants now.
This study's planned enrollment of 105 is above the median of 64 across 17 observational studies indexed under Pseudotumor Cerebri.
Browse Pseudotumor Cerebri studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
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The criteria were revised on the registry on Nov 10, 2026. See what changed
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with Idiopathic Intracranial Hypertension (IIH):
Healthy Controls:
Exclusion Criteria:
Patients with IIH:
Healthy Controls:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Total Choroid Plexus Volume
Total bilateral choroid plexus volume (mm³) measured using structural MRI.
Time frame: Baseline
Whole-Brain-Normalized Choroid Plexus Volume
Choroid plexus volume normalized to whole-brain volume, expressed as a dimensionless ratio.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Mean Cerebrospinal Fluid Velocity in the Cerebral Aqueduct
Mean cerebrospinal fluid velocity (cm/s) in the cerebral aqueduct measured using phase-contrast MRI.
Time frame: 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.
Time frame: Baseline
Total Perivascular Space Volume Fraction
Ratio of MRI-visible perivascular space volume to intracranial volume, derived from structural MRI.
Time frame: 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.
Time frame: Baseline
White Matter Free-Water Fraction
Extracellular free-water fraction in cerebral white matter estimated using diffusion MRI.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Whole-Brain Cerebral Blood Flow
Mean whole-brain cerebral blood flow (mL/100 g/min) measured using arterial spin labeling MRI.
Time frame: Baseline
Gray Matter Cerebral Blood Flow
Mean cerebral blood flow (mL/100 g/min) in gray matter measured using arterial spin labeling MRI.
Time frame: Baseline
White Matter Cerebral Blood Flow
Mean cerebral blood flow (mL/100 g/min) in white matter measured using arterial spin labeling MRI.
Time frame: 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).
Time frame: 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).
Time frame: Baseline
Cerebrospinal Fluid Opening Pressure
Cerebrospinal fluid opening pressure (mmH₂O) measured during clinically indicated lumbar puncture in patients with IIH.
Time frame: Baseline
Trans-Stenotic Venous Pressure Gradient
Pressure gradient (mmHg) across venous sinus stenosis measured during clinically indicated venous manometry in patients with IIH.
Time frame: Baseline
Visual Acuity
Visual acuity recorded as a numerical measure during ophthalmological examination in patients with IIH.
Time frame: Baseline
Visual Field Mean Deviation
Visual field mean deviation (dB) measured using automated perimetry in patients with IIH.
Time frame: Baseline
Frisén Papilledema Grade
Papilledema severity assessed using the Frisén grading scale (0-5), with higher grades indicating greater severity.
Time frame: Baseline
Retinal Nerve Fiber Layer Thickness
Retinal nerve fiber layer thickness (µm) measured using optical coherence tomography.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score
Health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score based on the Chinese value set. The score ranges from -0.391 to 1.000, where higher scores indicate better health-related quality of life (1.000 represents full health and values less than 0 represent states perceived as worse than death).
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Oral Symbol Digit Modalities Test Score
Information processing speed assessed using the oral version of the Symbol Digit Modalities Test (SDMT). The score is the number of correct symbol-digit substitutions completed within 90 seconds, ranging from 0 to 110. Higher scores indicate better information processing speed and cognitive performance.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Backward Digit Span Score
Working memory and attention assessed using the Backward Digit Span task of the Wechsler Adult Intelligence Scale (WAIS). The score reflects the total number of correctly recalled digit sequences in reverse order, ranging from 0 to 14. Higher scores indicate better working memory capacity and cognitive performance.
Time frame: Baseline
Change From Baseline in Whole-Brain-Normalized Choroid Plexus Volume
Change from baseline in choroid plexus volume normalized to whole-brain volume, measured using structural MRI.
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 Through the Cerebral Aqueduct
Change from baseline in net cerebrospinal fluid flow rate (mL/min) through the cerebral aqueduct measured using phase-contrast MRI.
Time frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Total Perivascular Space Volume Fraction
Change from baseline in the ratio of MRI-visible perivascular space volume to intracranial volume.
Time frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Overall DTI-ALPS Index
Change from baseline in the overall DTI-ALPS index derived from diffusion MRI.
Time frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in White Matter Free-Water Fraction
Change from baseline in white matter extracellular free-water fraction estimated using diffusion MRI.
Time frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Global BOLD-CSF Coupling
Change from baseline in the Pearson correlation coefficient between the global gray-matter BOLD signal and the CSF inflow signal.
Time frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Whole-Brain Cerebral Blood Flow
Change from baseline in mean whole-brain cerebral blood flow (mL/100 g/min) measured using arterial spin labeling MRI.
Time frame: 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
Change from baseline in apparent blood-brain barrier water exchange rate in white matter estimated using VEXI.
Time frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Frisén Papilledema Grade
Change from baseline in optic disc edema severity assessed using the Frisén Grading Scale for Papilledema. The scale ranges from Grade 0 to Grade 5, where 0 indicates a normal optic disc (no edema) and 5 indicates severe optic disc edema with major vessel obscuration. Higher grades indicate more severe papilledema; a decrease in grade from baseline indicates clinical improvement.
Time frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Change From Baseline in Visual Field Mean Deviation
Change from baseline in visual field mean deviation (dB) measured using automated perimetry.
Time frame: Baseline, 90 ± 14 days and 180 ± 30 days after clinical treatment (IIH patients only)
Plan to share: No — There is currently no plan to share individual participant data outside the study team.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2028, 15 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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