Advanced Neuroimaging in Idiopathic Intracranial Hypertension

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorThomas Jefferson University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

History of head trauma and shunting or leak repair

Major concurrent, active non-cephalic pain syndrome

Contradictions for MRIs

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: Patients with TSS

Trial outcomes

Primary outcomes

1

Advanced MRI measurements changes pre- and post-stenting

DTI-ALPS index

Time frame
3 months

Secondary outcomes

1

Clinical headache outcomes

Monthly headache days

Time frame
3 months

Other outcomes

1

Questionnaire outcomes

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

Time frame
3 months

Sponsors and contacts

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Thomas Jefferson University

Lead sponsor

American Headache Society

Collaborator