Evaluation of Brain Waste Clearance Pathways Using Magnetic Resonance Imaging in Pediatric Patients With White Matter Diseases

Active, not recruiting

• Conditions: Glymphatic System; White Matter Disease; Pediatric Disorder; Perivascular Disease
• Interventions: Diagnostic Test: Magnetic resonance imaging

• Registration Number: NCT06335004
• Lead Sponsor: IRCCS Eugenio Medea

Brief Summary

The dilation of perivascular spaces can be the result of various etiopathogenetic processes. White matter atrophy can cause enlargement of these perivascular spaces (PVS) but also obstruction of fluid drainage systems (interstitial fluid, ISF) and metabolites, as evidenced by some recent studies. Focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction. Dilation of PVS can be associated with changes in white matter and microhemorrhages. We want to study these etiopathogenetic phenomena by implementing specific MRI methods.

Detailed Description

Primary objective: the quantification of indirect magnetic resonance markers of altered waste drainage systems using validated scales in patients with white matter disease. Secondary objective: the evaluation of white matter alterations in relation to the known anatomical glymphatic pathways by analyzing both structural and diffusion data.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-05-05
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients with and without white matter disease
• patients willing to participate in research with signed consent form
• no age limit (results will be age matched)

Exclusion Criteria

• unwilling to participate in research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with no white matter disease	Magnetic resonance imaging	Patients undergoing MRI with or without gadolinium for clinical diagnostic purposes, with no known white matter disease.
Patients with white matter disease/healthy subjects	Magnetic resonance imaging	Patients with white matter disease due to genetic or acquired causes. MRI with or without intravenous gadolinium will be performed

Primary Outcome Measures

Name	Time	Method
Extent of white matter lesions	once at recruitment	T1 values of lesions
Number of perivascular spaces	once at recruitment	count of perivascular spaces and total volume in disease population
Volume of parasagittal dural space	once at recruitment	volume of parasagittal dural space in disease population

Trial Locations

Locations (1)

Scientific Institute IRCCS Eugenio Medea; 🇮🇹 Bosisio Parini, Lecco, Italy