Actively Recruiting

Age: 18Years - 55Years
All Genders
NCT06950099

Advanced Neuroimaging in Idiopathic Intracranial Hypertension

Led by Thomas Jefferson University · Updated on 2025-05-02

30

Participants Needed

1

Research Sites

43 weeks

Total Duration

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Sponsors

T

Thomas Jefferson University

Lead Sponsor

A

American Headache Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Advanced Neuroimaging in Idiopathic Intracranial Hypertension

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with refractory idiopathic intracranial hypertension who require and plan to have venous sinus stenting
Not Eligible

You will not qualify if you...

  • History of head trauma or prior brain shunting or leak repair surgery
  • Presence of major active non-head-related pain syndrome
  • Any contraindications to undergoing MRI scans

AI-Screening

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Trial Site Locations

Total: 1 location

1

Jefferson Headache Center

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

E

Enchao Qiu, MD PhD

CONTACT

M

Mary Hopkins

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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