Imaging - Clinical Evaluation of Altered Nervous System Drainage

NCT06432023 | Recruiting

• 1 other identifier: 1022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to evaluate the aspects of perfusion, fluid diffusivity in the interstitium and the T1 and T2 signal of the PVS and WMH. The current study has the following objectives: a) evaluate the perfusion aspects using the gadolinium-based contrast medium of brain tissues in the short term; b) the direction of flow of fluids at very low speed in the white matter using the DTI sequences configured for this purpose; c) T1-mapping of the lesions of interest. The expected results will help us understand two aspects of neurofluid dynamics: a) how the fluid moves within the central nervous system in the first minutes after the injection of the tracer (in our case the gadolinium-based contrast medium) and b) what is the composition of the fluid within the PVS and WMH and how can investigators characterize them more accurately.

Conditions

Neuroinflammation; Autism Spectrum Disorder

Keywords

magnetic resonance imaging; autism spectrum disorder; white matter disease; glymphatic system; brain waste clearance

Outcome Measures

Primary Outcomes (3)

• Perivascular space count

  Number and distribution of enlarged perivascular spaces

  once at recruitment

• Volume of parasagittal dura

  correlation of parasagittal dura and perivascular count

  once at recruitment

• fMRI signal during sedation

  effect of sedation on BOLD signal

  once at recruitment

Study Arms (2)

Patients

patients with white matter hyperintensities, patients with enlarged perivascular spaces, Focus will be on patients with a clinical diagnosis of muscular dystrophy or autism spectrum disorder or traumatic brain injury.

Diagnostic Test: Magnetic resonance imaging

Controls

Patients who need a diagnostic scan but do not carry a diagnosis of psychomotor or cognitive impairment or without a history of TBI and tumors. No white matter hyperintensities.

Diagnostic Test: Magnetic resonance imaging

Interventions

Magnetic resonance imaging DIAGNOSTIC_TEST

Diagnostic and research scanning using magnetic resonance imaging.

Controls; Patients

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with obvious white matter disease on T2 and FLAIR sequences will be included in this study. In particular patients with recent diagnosis of autism spectrum disorder, traumatic brain injury, Steinert's muscular dystrophy will be included.

You may qualify if:

• patients with white matter lesions and/or enlarged perivascular spaces

You may not qualify if:

• have contraindications to the use of contrast medium;
• are clinically unstable patients and prolonged sedation is inappropriate
• have tumors
• contraindications to perform MR.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Neuroinflammatory Diseases; Autism Spectrum Disorder; Leukoencephalopathies

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 29, 2024
• Study Start: October 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: January 31, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

IT (1)