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NCT06950099: IIH
Advanced Neuroimaging in Idiopathic Intracranial Hypertension
trial in Idiopathic Intracranial Hypertension (IIH) in 30 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Thomas Jefferson University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 3 March 2025 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across United States |
Conditions studied
- Idiopathic Intracranial Hypertension (IIH) — all drugs for Idiopathic Intracranial Hypertension (IIH) →
- Glymphatic System — all drugs for Glymphatic System →
Sponsor
Thomas Jefferson University
Who can join
Adults 18 to 55, any sex, with Idiopathic Intracranial Hypertension (IIH) or Glymphatic System. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06950099
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Related trials
Other recruiting trials for Idiopathic Intracranial Hypertension (IIH)
Currently open trials in the same condition.
- NCT06945848 — Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide · NA · recruiting
- NCT06919744 — Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase · NA · recruiting
- NCT06913712 — BMI in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment · recruiting
- NCT06692790 — VEHICLE Registry: Venous Stenting for IIH in the MENA Region · recruiting
Other Thomas Jefferson University trials
Trials by the same sponsor.
- NCT07526480 — Improving Dementia Care in Primary Practice · NA · not yet recruiting
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- NCT07402018 — Intra-aortic Balloon Counterpulsation (IABC) Compliance · recruiting
- NCT07217197 — Respiratory Monitoring System That Detects & Predicts OIRD · NA · enrolling by invitation
- NCT07145099 — The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06950099 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Thomas Jefferson University
- Last refreshed: 2 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06950099.
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