Advanced Neuroimaging in Idiopathic Intracranial Hypertension (IIH)

Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: Glymphatic System; Idiopathic Intracranial Hypertension (IIH)

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Enchao Qiu, MD PhD; Phone Number: 215-955-1149; Email: enchao.qiu@jefferson.edu
• Study Contact Backup: Name: Mary Hopkins; Phone Number: 215 955-2680; Email: mary.hopkins@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Jefferson Headache Center
      • Contact: Mary Hopkins; Phone Number: 215-955-2680; Email: mary.hopkins@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with TSS; Pre- and post-stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advanced MRI measurements changes pre- and post-stenting	DTI-ALPS index	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical headache outcomes	Monthly headache days	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire outcomes	Quality of life using Physicians Global Assessment (from 0 to 10, 0=free of complaints, 10=strong discomfort),	3 months

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: American Headache Society
• Investigators: Principal Investigator: Hsiangkuo Yuan, MD PhD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: MRI; diffusion tensor imaging; idiopathic intracranial hypertension; IIH
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hypertension; Intracranial Hypertension; Pseudotumor Cerebri
• Other Study ID Numbers: JT44344 fMRI in IIH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No