New MRI method for detecting brain issues in Sturge-Weber syndrome

Longitudinal Neuroimaging in Sturge-Weber Syndrome

This study is testing a new, quick MRI method to see if it can better spot brain problems in kids and young adults with Sturge-Weber syndrome compared to regular MRIs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 3 Months to 30 Years
• Sex: All
• Sponsor: Wayne State University (Academic / other)
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT04517565 on ClinicalTrials.gov

What this trial studies

This project aims to evaluate a novel, rapid magnetic resonance imaging (MRI) technique designed to identify brain abnormalities in patients with Sturge-Weber syndrome (SWS). The study will compare the accuracy of this new imaging approach, which can produce various MR images in about 5 minutes without the need for sedation or contrast, to standard MRI methods. Additionally, advanced MRI techniques will be utilized to assess brain vascular and neuronal changes, with the goal of improving neurological and cognitive outcomes for affected children and young adults. Participants will undergo both advanced brain MRI and neurocognitive evaluations to support these objectives.

Who should consider this trial

Good fit: Ideal candidates include children and young adults aged 3 months to 30 years diagnosed with Sturge-Weber syndrome, particularly those with a facial port-wine birthmark or evidence of brain abnormalities.

Not a fit: Patients with metal implants in their head or mouth that prevent safe MRI scanning will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and intervention strategies for children with Sturge-Weber syndrome, potentially minimizing neurocognitive deficits.

How similar studies have performed: While this approach is innovative, similar studies utilizing advanced MRI techniques have shown promise in other pediatric brain disorders, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Subjects with Sturge-Weber syndrome (SWS):

   1. Age 3 months - 30 years;
   2. Presence of a facial port-wine birthmark (PWB) indicating a risk for SWS and/or evidence of SWS brain involvement based on the presence of one or more intracranial SWS brain abnormalities from previous clinical imaging (MRI or computed tomography) scan(s) with or without a facial PWB. SWS brain abnormalities can include both brain vascular and/or parenchymal abnormalities (including atrophy, calcification, etc.);
   3. In children who will undergo formal neuropsychology testing including detailed language testing (age 3 years and above): proficiency of English language.
2. Healthy control subjects:

   1. Age 3 years - 30 years;
   2. No history of neurological or psychiatric disorder

Exclusion Criteria:

For all subjects:

1. Metal in the head or mouth that would preclude safe, artifact-free MRI scanning; or any other metal or electronic device contraindicated for MRI scanning.
2. History of severe claustrophobia, precluding staying still in the scanner for up to 30 minutes.
3. Pregnancy (pregnant women will be scheduled for the study after delivery).

For SWS subjects, who will receive MRI contrast material, additional exclusion criteria:

1. History of sensitivity to MRI contrast material;
2. History of renal disease that would preclude safe administration of MRI contrast material

Where this trial is running

Detroit, Michigan

• Wayne State University / Children's Hospital of Michigan — Detroit, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: Csaba Juhasz, MD, PhD

Conditions Sturge-Weber Syndrome