Advanced Neuroimaging in Idiopathic Intracranial Hypertension

NCT ID: NCT06950099

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-12-31

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with TSS

Pre- and post-stenting

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Headache Society

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiangkuo Yuan, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Jefferson Headache Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Enchao Qiu, MD PhD

Role: CONTACT

enchao.qiu@jefferson.edu

215-955-1149

Mary Hopkins

Role: CONTACT

mary.hopkins@jefferson.edu

215 955-2680

Facility Contacts

Mary Hopkins

Role: primary

mary.hopkins@jefferson.edu

215-955-2680

Other Identifiers

JT44344 fMRI in IIH

Identifier Type: -

Identifier Source: org_study_id