Longitudinal study on brain development in children with sickle cell disease
Brain Structure and Neurocognitive Development in Sickle Cell Disease; a Longitudinal Cohort Study (BRICK Study)
Erasmus Medical Center · NCT05564845
This study is trying to see how sickle cell disease affects brain development and thinking skills in children and teenagers over four years compared to healthy kids.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 6 Years to 25 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center (other) |
| Locations | 2 sites (Rotterdam, South Holland and 1 other locations) |
| Trial ID | NCT05564845 on ClinicalTrials.gov |
What this trial studies
This study evaluates the changes in brain structure and neurocognitive development in children and adolescents aged 6-18 years with sickle cell disease (SCD) over a four-year period. It aims to understand the relationship between brain structure, biomarkers, and cognitive functioning by comparing SCD patients with a healthy cohort. Participants will undergo MR scans, blood work, neurological examinations, and neuropsychological assessments to gather comprehensive data on brain health and cognitive abilities. The study seeks to identify the timing and nature of brain tissue damage in relation to other organ systems affected by SCD.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6-18 years diagnosed with sickle cell disease of any genotype.
Not a fit: Patients with prior abnormal brain MRIs unrelated to sickle cell disease or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cognitive impairments in children with sickle cell disease.
How similar studies have performed: While studies on sickle cell disease exist, this longitudinal approach focusing on brain development is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with SCD of all genotype between 6 and 18 at baseline Exclusion Criteria: * Parents/ guardians (in case of minors) or patients themselves (\>16 years) unable to make an informed decision on participating in this study. * An abnormal brain MRI prior to initiation of the study due to non-SCD related causes. * Contraindications for brain MRI per protocol
Where this trial is running
Rotterdam, South Holland and 1 other locations
- Erasmus MC — Rotterdam, South Holland, Netherlands (RECRUITING)
- Amsterdam University Medical Center — Amsterdam, Netherlands (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Aida Kidane
- Email: a.kidanegebremeskel@erasmusmc.nl
- Phone: +3110-7036691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Development Abnormality, Sickle Cell Disease, brain development, Sickle cell disease