Aún no reclutaNCT07915453Registro de ClinicalTrials.gov

Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension

Idiopathic Intracranial Hypertension

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: Observacional
Fase: No aplica / no indicada
Rango de edad: 18 años - 60 años
Sexo admitido: Todos los sexos
Voluntarios sanos: Aceptados
Participantes: 105 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

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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.

Población del estudio

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No informado
Enmascaramiento: No informado

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Total Choroid Plexus Volume

Plazo: Baseline

Total bilateral choroid plexus volume (mm³) measured using structural MRI.

Whole-Brain-Normalized Choroid Plexus Volume

Plazo: Baseline

Choroid plexus volume normalized to whole-brain volume, expressed as a dimensionless ratio.

Peak Systolic Cerebrospinal Fluid Velocity in the Cerebral Aqueduct

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: Baseline

Net cerebrospinal fluid flow rate (mL/min) through the cerebral aqueduct measured using cardiac-gated phase-contrast MRI.

Total Perivascular Space Volume Fraction

Plazo: Baseline

Ratio of MRI-visible perivascular space volume to intracranial volume, derived from structural MRI.

Overall Diffusion Tensor Imaging Along the Perivascular Space Index

Plazo: 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

Plazo: Baseline

Extracellular free-water fraction in cerebral white matter estimated using diffusion MRI.

Diffusion Tensor Imaging-Estimated Periventricular Diffusivity Index

Plazo: 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

Plazo: 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

Plazo: Baseline

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

Gray Matter Cerebral Blood Flow

Plazo: Baseline

Mean cerebral blood flow (mL/100 g/min) in gray matter measured using arterial spin labeling MRI.

White Matter Cerebral Blood Flow

Plazo: 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

Plazo: 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

Plazo: Baseline

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

Medidas secundarias

Cerebrospinal Fluid Opening Pressure

Plazo: Baseline

Cerebrospinal fluid opening pressure (mmH₂O) measured during clinically indicated lumbar puncture in patients with IIH.

Trans-Stenotic Venous Pressure Gradient

Plazo: Baseline

Pressure gradient (mmHg) across venous sinus stenosis measured during clinically indicated venous manometry in patients with IIH.

Visual Acuity

Plazo: Baseline

Visual acuity recorded as a numerical measure during ophthalmological examination in patients with IIH.

Visual Field Mean Deviation

Plazo: Baseline

Visual field mean deviation (dB) measured using automated perimetry in patients with IIH.

Frisén Papilledema Grade

Plazo: Baseline

Papilledema severity assessed using the Frisén grading scale (0-5), with higher grades indicating greater severity.

Retinal Nerve Fiber Layer Thickness

Plazo: Baseline

Retinal nerve fiber layer thickness (µm) measured using optical coherence tomography.

Headache Impact Test-6 Score

Plazo: 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.

Tinnitus Handicap Inventory Score

Plazo: Baseline

Total score on the Tinnitus Handicap Inventory (THI), ranging from 0 to 100, with higher scores indicating greater tinnitus-related handicap.

EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score

Plazo: Baseline

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).

Mini-Mental State Examination Score

Plazo: Baseline

Total score on the Mini-Mental State Examination (MMSE), ranging from 0 to 30, with higher scores indicating better cognitive performance.

Montreal Cognitive Assessment Score

Plazo: Baseline

Total score on the Montreal Cognitive Assessment (MoCA), ranging from 0 to 30, with higher scores indicating better cognitive performance.

Oral Symbol Digit Modalities Test Score

Plazo: Baseline

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.

Trail Making Test Part A Completion Time

Plazo: Baseline

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

Trail Making Test Part B Completion Time

Plazo: Baseline

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

Stroop Color-Word Interference Completion Time

Plazo: Baseline

Completion time (seconds) for the interference condition of the Stroop Color-Word Test, with longer times indicating poorer performance.

Backward Digit Span Score

Plazo: Baseline

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.