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

Valutazione Delle Vie Glinfatiche Utilizzando la Risonanza Magnetica Nelle Malattie Della Sostanza Bianca

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06335004
Enrollment
100
Registered
2024-03-28
Start date
2022-03-01
Completion date
2025-02-28
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glymphatic System, Pediatric Disorder, Perivascular Disease, White Matter Disease

Keywords

Glymphatic system, white matter disease, perivascular space, diffusion tensor imaging, gadolinium, rare disease

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.

Interventions

DIAGNOSTIC_TESTMagnetic resonance imaging

Patients will undergo a magnetic resonance imaging for clinical purposes to which additional sequences. Post gadolinium research sequences will be acquired only if intravenous gadolinium needs to be administered for clinical purposes.

Sponsors

IRCCS Eugenio Medea
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Months to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Extent of white matter lesionsonce at recruitmentT1 values of lesions
Number of perivascular spacesonce at recruitmentcount of perivascular spaces and total volume in disease population
Volume of parasagittal dural spaceonce at recruitmentvolume of parasagittal dural space in disease population

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026