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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
In children who will undergo formal neuropsychology testing including detailed language testing (age 3 years and above): proficiency of English language
No history of neurological or psychiatric disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Study Summary
This trial is testing the accuracy of a new, rapid MRI approach to detect brain abnormalities in patients with Sturge-Weber syndrome (SWS). The new imaging approach can create multiple types of MR images in about 5 minutes, without contrast administration (and sedation even in young children). 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 is the study for?
This trial is for individuals aged 3 months to 30 years with Sturge-Weber syndrome (SWS) or at risk due to a facial port-wine birthmark. Healthy controls without neurological/psychiatric disorders can also join. Exclusions include metal in the body, pregnancy, MRI contrast sensitivity, renal disease, and severe claustrophobia.Check my eligibility
What is being tested?
The study tests a new rapid MRI technique that captures multiple images quickly without contrast agents and sedation. It aims to identify brain abnormalities in SWS patients and understand vascular/neuronal changes that could inform future interventions.See study design
What are the potential side effects?
There are no direct side effects from the non-invasive neuro-psychology testing or advanced brain MRI being used in this trial; however, some participants may experience discomfort or anxiety during the imaging process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child, who is 3 or older, speaks English well.
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I have no history of mental health or neurological conditions.
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I am between 3 months and 30 years old.
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I am between 3 and 30 years old.
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I am between 3 months and 30 years old with Sturge-Weber syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain
Correlation of diffusion tensor imaging (DTI) brain connectivity score with non-verbal IQ acquired within 1 day.
Correlation of diffusion tensor imaging (DTI) brain connectivity score with verbal IQ acquired within 1 day.
+1 moreSecondary outcome measures
Correlation of enlarged deep vein scores determined by magnetic resonance imaging (MRI) with motor scores acquired within 1 day.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with SWS or high-risk facial port-wine birthmarkExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Wayne State UniversityLead Sponsor
310 Previous Clinical Trials
109,016 Total Patients Enrolled
1 Trials studying Sturge-Weber Syndrome
250 Patients Enrolled for Sturge-Weber Syndrome
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,366 Total Patients Enrolled
3 Trials studying Sturge-Weber Syndrome
650 Patients Enrolled for Sturge-Weber Syndrome
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 3 and 30 years old and healthy.You have a specific type of birthmark on your face, or evidence of a related brain condition.My child, who is 3 or older, speaks English well.I have no history of mental health or neurological conditions.I am not currently pregnant.I do not have kidney disease that would make MRI contrast unsafe.I am between 3 months and 30 years old.I am between 3 and 30 years old.You have metal in your head or mouth that would make it unsafe to have an MRI scan, or you have any other metal or electronic device that should not be used during an MRI scan.I am between 3 months and 30 years old with Sturge-Weber syndrome.You have a history of feeling very scared in small, enclosed spaces and can't stay still in a scanner for up to 30 minutes.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with SWS or high-risk facial port-wine birthmark
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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