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NCT06950099Recruiting

Advanced Neuroimaging in Idiopathic Intracranial Hypertension

Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging

Source: ClinicalTrials.gov · Last updated 2 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
24 Mar 2025
Start date
3 Mar 2025
Primary completion date
31 Dec 2025
Lead sponsor
Thomas Jefferson University
NCT number
NCT06950099

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 3 Mar 2025 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Major concurrent, active non-cephalic pain syndrome

Other illness

  • History of head trauma and shunting or leak repair

Other

  • Contradictions for MRIs

Who the study is looking for

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

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jefferson Headache Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.