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NCT Number: NCT06950099

Advanced Neuroimaging in Idiopathic Intracranial Hypertension

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Mary Hopkins

CONTACT

[email protected]

215-955-2680

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Advanced MRI measurements changes pre- and post-stenting

    Time frame: 3 months

    DTI-ALPS index

Secondary outcomes

  1. Clinical headache outcomes

    Time frame: 3 months

    Monthly headache days

Other outcomes

  1. Questionnaire outcomes

    Time frame: 3 months

    Quality of life using Physicians Global Assessment (from 0 to 10, 0=free of complaints, 10=strong discomfort),

Study contacts

Contact information is provided by the study sponsor or research team.

Enchao Qiu, MD PhD

CONTACT

[email protected]

215-955-1149

Mary Hopkins

CONTACT

[email protected]

215 955-2680

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • American Headache Society

Registry information

Official study title

Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging

Acronym: IIH

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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