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Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension

29 ottobre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

105

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: CASE_CONTROL
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Choroid Plexus Volume
Lasso di tempo: Baseline

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

Choroid plexus volume normalized to whole-brain volume, expressed as a dimensionless ratio.
Baseline
Peak Systolic Cerebrospinal Fluid Velocity in the Cerebral Aqueduct
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline

Extracellular free-water fraction in cerebral white matter estimated using diffusion MRI.
Baseline
Diffusion Tensor Imaging-Estimated Periventricular Diffusivity Index
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline

Mean whole-brain cerebral blood flow (mL/100 g/min) measured using arterial spin labeling MRI.
Baseline
Gray Matter Cerebral Blood Flow
Lasso di tempo: Baseline

Mean cerebral blood flow (mL/100 g/min) in gray matter measured using arterial spin labeling MRI.
Baseline
White Matter Cerebral Blood Flow
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline

Apparent blood-brain barrier water exchange rate (AXR_BBB) in deep gray matter estimated using vascular water exchange imaging (VEXI).
Baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cerebrospinal Fluid Opening Pressure
Lasso di tempo: Baseline

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

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

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

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

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

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

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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Whole-Brain-Normalized Choroid Plexus Volume
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beijing Tiantan Hospital

Investigatori

  • Investigatore principale: Dapeng Mo, PhD, Beijing Tiantan Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 febbraio 2028

Completamento dello studio (Stimato)

1 agosto 2028

Date di iscrizione allo studio

Primo inviato

29 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 ottobre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HX-B-2026054

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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