Jefferson Headache Center
Philadelphia, Pennsylvania, 19107, United States
Location status: Recruiting
NCT Number: NCT06950099
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Observational
Philadelphia, Pennsylvania, 19107, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months
DTI-ALPS index
Time frame: 3 months
Monthly headache days
Time frame: 3 months
Quality of life using Physicians Global Assessment (from 0 to 10, 0=free of complaints, 10=strong discomfort),
Contact information is provided by the study sponsor or research team.
Enchao Qiu, MD PhD
CONTACT
Mary Hopkins
CONTACT
Thomas Jefferson University
Other
Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging
Acronym: IIH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06913712
Brain Diseases, Central Nervous System Diseases
Valencia, Spain
View Trial DetailsNCT06945848
Brain Diseases, Central Nervous System Diseases
Montpellier, France
View Trial DetailsNCT06919744
Brain Diseases, Central Nervous System Diseases
Montpellier, France
View Trial DetailsNCT07191873
Brain Diseases, Central Nervous System Diseases
Durham, North Carolina, United States
View Trial Details