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NCT06950099 · ClinicalTrials.gov registry record

Advanced Neuroimaging in Idiopathic Intracranial Hypertension

A clinical trial of Idiopathic Intracranial Hypertension (IIH) and Glymphatic System, sponsored by Thomas Jefferson University.

Recruiting
Registry status
30
Enrollment target
1
Study location

NCT06950099: Recruiting study of Idiopathic Intracranial Hypertension (IIH) and Glymphatic System, sponsored by Thomas Jefferson University.

NCT06950099 is a study of Idiopathic Intracranial Hypertension (IIH) and Glymphatic System that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 30 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06950099, a study of Idiopathic Intracranial Hypertension (IIH) and Glymphatic System, is actively recruiting participants, sponsored by Thomas Jefferson University.

RECRUITING
Registry status
30 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

DTI-ALPS index

Study Locations (1)

Pennsylvania

  • Jefferson Headache Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-03-03
Est. Completion 2025-12-31
Thomas Jefferson University

292 total trials

What NCT06950099 shows while recruiting

NCT06950099 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.

The record links to 2 conditions, with Idiopathic Intracranial Hypertension (IIH) appearing as the primary indexed condition, and to 0 interventions.

NCT06950099 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06950099 about?

NCT06950099 is a clinical study titled "Advanced Neuroimaging in Idiopathic Intracranial Hypertension". 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 stenos...

What is the current status of trial NCT06950099?

This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2025-03-03. Estimated completion is 2025-12-31.

What conditions does trial NCT06950099 study?

This clinical trial studies the following conditions: Idiopathic Intracranial Hypertension (IIH), Glymphatic System.

Who is sponsoring clinical trial NCT06950099?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06950099 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06950099, the US trial registry maintained by the National Library of Medicine. NCT06950099 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.