RecruitingNCT06950099

Advanced Neuroimaging in Idiopathic Intracranial Hypertension

Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging


Sponsor

Thomas Jefferson University

Enrollment

30 participants

Start Date

Mar 3, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is using advanced brain imaging (neuroimaging) to better understand what happens in the brain of patients with idiopathic intracranial hypertension (IIH) — a condition where the pressure around the brain is too high without a known cause — before and after a procedure called venous sinus stenting (placing a small tube to improve blood drainage from the brain). **You may be eligible if...** - You have been diagnosed with IIH that has not responded to medical treatment (refractory IIH) - You are already planning to undergo a venous sinus stenting procedure as part of your treatment **You may NOT be eligible if...** - You have a history of significant head trauma, a brain shunt, or a cerebrospinal fluid leak repair - You have another significant chronic pain condition in the body (not related to headache) - You cannot safely undergo an MRI scan (due to certain implants or other contraindications) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Jefferson Headache Center

Philadelphia, Pennsylvania, United States

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NCT06950099


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