Advanced Neuroimaging in Idiopathic Intracranial Hypertension

NCT06950099 | Recruiting

• 1 other identifier: JT44344 fMRI in IIH
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

idiopathic intracranial hypertension; MRI; diffusion tensor imaging; IIH

Outcome Measures

Primary Outcomes (1)

• Advanced MRI measurements changes pre- and post-stenting

  DTI-ALPS index

  3 months

Secondary Outcomes (1)

• Clinical headache outcomes

  3 months

Other Outcomes (1)

• Questionnaire outcomes

  3 months

Study Arms (1)

Patients with TSS

Pre- and post-stenting

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• History of head trauma and shunting or leak repair
• Major concurrent, active non-cephalic pain syndrome
• Contradictions for MRIs

Sponsors & Collaborators

• Thomas Jefferson University: lead
• American Headache Society: collaborator

Study Sites (1)

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hsiangkuo Yuan, MD PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enchao Qiu, MD PhD

CONTACT

215-955-1149; enchao.qiu@jefferson.edu

Mary Hopkins

CONTACT

215 955-2680; mary.hopkins@jefferson.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 29, 2025
• Study Start: March 3, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

US (1)