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Advanced Neuroimaging in Idiopathic Intracranial Hypertension

Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06950099
Acronym
IIH
Enrollment
30
Registered
2025-04-29
Start date
2025-03-03
Completion date
2025-12-31
Last updated
2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glymphatic System, Idiopathic Intracranial Hypertension (IIH)

Keywords

idiopathic intracranial hypertension, MRI, diffusion tensor imaging, IIH

Brief summary

Idiopathic intracranial hypertension (IIH) is characterized by elevated intracranial pressure leading to symptoms like papilledema, headache, and cognitive dysfunction. While the etiology is complex, abnormal cerebrospinal fluid dynamics due to venous outflow restriction from transverse sinus stenosis (TSS) is common. TSS may disrupt the glymphatic system, a brain-wide network facilitating cerebrospinal fluid and interstitial fluid exchange, by impairing CSF absorption, altering perivascular space dynamics, and disrupting pressure gradients crucial for waste clearance. Venous sinus stenting (VSS) can improve symptoms in many patients by alleviating venous congestion, but its effects on glymphatic function are unclear. This prospective study aims to evaluate novel quantitative brain imaging metrics as surrogate markers to better understand IIH pathophysiology before and after VSS in patients with refractory IIH and TSS. The investigators will use advanced MRI techniques, including MR elastography (MRE) to assess brain stiffness, diffusion tensor imaging (DTI) to evaluate water diffusion, arterial spin labeling (ASL) imaging to measure blood-brain barrier (BBB) permeability, and functional MRI to analyze pain networks. The investigators hypothesize that 1) these noninvasive imaging metrics will correlate with the degree of venous congestion and changes after venous sinus stenting (VSS) and 2) the imaging findings will correlate with clinical treatment outcomes. By correlating imaging markers with venous pressures and symptom changes, the investigators aim to gain insights into IIH mechanisms, expand diagnostic tools, and potentially guide clinical decision-making and treatment response monitoring. The overarching goal is to better understand IIH's underlying pathophysiology, which could lead to improved diagnostic criteria, more targeted treatments, and better prediction of treatment outcomes for patients with this challenging condition.

Interventions

None listed

Sponsors

American Headache Society
CollaboratorOTHER
Thomas Jefferson University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

• Refractory IIH patients who require and plan to have a venous sinus stenting

Exclusion criteria

* History of head trauma and shunting or leak repair * Major concurrent, active non-cephalic pain syndrome * Contradictions for MRIs

Design outcomes

Primary

MeasureTime frameDescription
Advanced MRI measurements changes pre- and post-stenting3 monthsDTI-ALPS index

Secondary

MeasureTime frameDescription
Clinical headache outcomes3 monthsMonthly headache days

Other

MeasureTime frameDescription
Questionnaire outcomes3 monthsQuality of life using Physicians Global Assessment (from 0 to 10, 0=free of complaints, 10=strong discomfort),

Countries

United States

Contacts

Primary ContactEnchao Qiu, MD PhD
enchao.qiu@jefferson.edu215-955-1149
Backup ContactMary Hopkins
mary.hopkins@jefferson.edu215 955-2680

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026