RECRUITING

Advanced Neuroimaging in Idiopathic Intracranial Hypertension

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging

Quick Facts

Study Start:2025-03-03
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06950099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * History of head trauma and shunting or leak repair
  2. * Major concurrent, active non-cephalic pain syndrome
  3. * Contradictions for MRIs

Contacts and Locations

Study Contact

Enchao Qiu, MD PhD
CONTACT
215-955-1149
enchao.qiu@jefferson.edu
Mary Hopkins
CONTACT
215 955-2680
mary.hopkins@jefferson.edu

Principal Investigator

Hsiangkuo Yuan, MD PhD
PRINCIPAL_INVESTIGATOR
Thomas Jefferson University

Study Locations (Sites)

Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

  • Hsiangkuo Yuan, MD PhD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-03-03
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Idiopathic Intracranial Hypertension (IIH)
  • Glymphatic System