NCT07915453Not yet recruiting
Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 105 (estimated)
- First submitted
- 29 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- High blood pressure
- NCT number
- NCT07915453
What you commit to
- Study type: Observational
- Planned participants: 105
- From 1 Nov 2026 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgical or endovascular procedures substantially affecting intracranial pressure or cerebral venous drainage.
Other illness
- Secondary intracranial hypertension due to cerebral venous sinus thrombosis, intracranial infection, mass lesions, hydrocephalus, or other identifiable causes.
- 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.
- Severe systemic illness or MRI contraindications.
- Any other condition considered unsuitable for participation by the investigator.
- 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.
- Severe systemic illness preventing completion of study examinations.
- Any other condition considered unsuitable for participation by the investigator.
Other
- Patients with IIH:
- Pregnancy or breastfeeding.
- Inadequate baseline MRI quality or substantial missing clinical data preventing reliable analysis.
- Healthy Controls:
- Pregnancy or breastfeeding.
- MRI contraindications.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.