Clinical trial · Interventional
Longitudinal Neuroimaging in Sturge-Weber Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this project the accuracy of a novel, rapid magnetic resonance imaging (MRI) approach to detect brain abnormalities in patients with Sturge-Weber syndrome (SWS) will be tested; this new imaging approach, that can create multiple types of MR images in about 5 minutes, without contrast administration (and sedation even in young children), can be also readily applied in other pediatric brain disorders in the future. The investigators will also study how advanced MRI, including susceptibility-weighted and diffusion tensor imaging can detect detailed signs of brain vascular and neuronal reorganization that helps improve neurological and cognitive outcome of children and young adults with SWS, who could benefit from targeted interventions in the future to minimize neurocognitive deficits in affected patients. All enrolled subjects will undergo advanced brain MRI and neurocognitive evaluation to achieve these goals.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sturge-Weber Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain magnetic resonance imaging | Diagnostic Test | — | UNRESOLVED |
| Neuro-psychology testing | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with SWS or high-risk facial port-wine birthmark
- description
- All patients with SWS brain involvement (based on previous imaging) or facial port-wine birthmark indicating a high risk for SWS brain involvement will undergo a brain MRI and neuro-psychology testing.
- interventionNames
- Diagnostic Test: Brain magnetic resonance imaging
- Behavioral: Neuro-psychology testing
Primary outcomes (4)
- measure
- Accuracy of detection of Sturge-Weber syndrome brain involvement by a novel fast magnetic resonance imaging (MRI) approach as compared to standard MRI.
- timeFrame
- During procedure
- description
- Presence (score 1) vs. absence (score 0) of SWS brain abnormalities in each of 8 cerebral lobes using fast MRI compared with the same scores obtained from standard MRI, obtained in the same imaging session, as the ground truth.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Months
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available