Actively Recruiting
Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging
Led by Thomas Jefferson University · Updated on 2025-05-02
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
A
American Headache Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Idiopathic intracranial hypertension (IIH) is a condition where high pressure inside the skull causes symptoms like swelling of the optic nerve (papilledema), headaches, and problems with thinking. This condition often involves problems with blood flow in the brain veins, especially narrowing of the transverse sinus (TSS), which may affect the brain's system for clearing waste called the glymphatic system. Researchers are studying how advanced brain imaging can help understand these changes before and after a procedure called venous sinus stenting (VSS), which may relieve pressure by improving vein flow in patients with difficult-to-treat IIH and TSS. The study uses several advanced MRI techniques to measure brain stiffness, water movement, blood-brain barrier permeability, and pain-related brain activity. These imaging methods will be done before and three months after VSS to see how brain function changes. Researchers will compare imaging results with venous pressure and symptoms to learn more about the disease and how well VSS works. This observational study tracks patients who need VSS as part of their care. Participants will have brain MRIs before and after the stenting procedure, with follow-up at three months to assess changes in imaging and headache symptoms. The main outcome is the change in advanced MRI measurements, while secondary outcomes include clinical headache improvements. This helps researchers understand IIH better, develop new diagnostic tools, and improve treatment monitoring. The study is open to adults aged 18 to 55 with refractory IIH planning VSS and lasts at least three months after treatment.
CONDITIONS
Brief Title
Advanced Neuroimaging in Idiopathic Intracranial Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 55 years
- Diagnosed with refractory idiopathic intracranial hypertension (IIH)
- Planned to undergo venous sinus stenting (VSS)
You will not qualify if you...
- History of head trauma or brain shunting or leak repair
- Major ongoing, active pain conditions not related to the head
- Contraindications to MRI scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 months
Participants undergo advanced MRI imaging before and after venous sinus stenting to evaluate idiopathic intracranial hypertension.
2 visits (pre- and post-stenting, in-person)
Trial Site Locations
Total: 1 location
1
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
E
Enchao Qiu, MD PhD
M
Mary Hopkins
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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