NCT06950099 Advanced Neuroimaging in Idiopathic Intracranial Hypertension
| NCT ID | NCT06950099 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Thomas Jefferson University |
| Condition | Idiopathic Intracranial Hypertension (IIH) |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-03-03 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Hsiangkuo Yuan, MD PhD
PRINCIPAL INVESTIGATOR
Thomas Jefferson University
Frequently Asked Questions
Who can join the NCT06950099 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Idiopathic Intracranial Hypertension (IIH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06950099 currently recruiting?
Yes, NCT06950099 is actively recruiting participants. Contact the research team at enchao.qiu@jefferson.edu for enrollment information.
Where is the NCT06950099 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06950099 clinical trial?
NCT06950099 is sponsored by Thomas Jefferson University. The principal investigator is Hsiangkuo Yuan, MD PhD at Thomas Jefferson University. The trial plans to enroll 30 participants.