Recruiting

Observational Study

Sponsor:

Thomas Jefferson University

Code:

NCT06950099

Conditions

Idiopathic Intracranial Hypertension (IIH)

Glymphatic System

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Idiopathic Intracranial Hypertension (IIH)

Glymphatic System

Study ID

NCT06950099

Start date

Mar 3, 2025

Status verified date

Apr, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with TSS

Pre- and post-stenting

Primary outcome measure

  • Advanced MRI measurements changes pre- and post-stenting [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Jefferson Headache Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

More Information

Sponsor

Thomas Jefferson University

Last update posted

May 2, 2025

Last verified

Apr, 2025

Keywords

  • idiopathic intracranial hypertension
  • MRI
  • diffusion tensor imaging
  • IIH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-05-02.