Understanding cognitive function in children with brain tumors
Cognitive Biomarkers in Pediatric Brain Tumor Patients
This study looks at how brain tumors affect thinking skills in children aged 4-18 to help understand their cognitive challenges better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT02914067 on ClinicalTrials.gov |
What this trial studies
This study investigates cognitive function in pediatric patients aged 4-18 diagnosed with brain tumors. It focuses on acquiring high-quality data during the peri-diagnostic period and aims to develop predictive models for cognitive outcomes through serial examinations of functional imaging and cognitive assessments. The study includes three cohorts: newly diagnosed patients, those with previously diagnosed posterior fossa tumors, and patients with posterior fossa syndrome who cannot complete standard cognitive tests. The goal is to better understand cognitive deficits associated with various tumor types.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-18 with newly diagnosed brain tumors or those with specific previous diagnoses related to posterior fossa tumors.
Not a fit: Patients with significant visual impairments or contraindications to MRI scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive outcome predictions and tailored interventions for children with brain tumors.
How similar studies have performed: Other studies have shown promise in using cognitive assessments and imaging to understand brain function in pediatric populations, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Cohort 1 (30 patients will be enrolled to this cohort) Inclusion Criteria: * Between 4 and 18 years of age, inclusive * Newly diagnosed primary brain tumor of any location and any histology * Life expectancy of at least one year * Able to understand and willing to consent or assent to the research proposed, along with consent of legal guardian(s) if applicable Exclusion Criteria: * Presence of visual impairment to an extent that the patient is unable to complete the computer testing * Contraindication to MRI scan (i.e. due to cardiac pacemaker) * Programmable Shunt Cohort 2 (150 patients will enrolled to this cohort. This may include some or all of the patients enrolled to Cohort 1.) Inclusion Criteria: * Between 4 and 18 years of age, inclusive * Previous diagnosis of a posterior fossa brain tumor; patients who are either undergoing active treatment for posterior fossa tumor or who have completed treatment will be eligible for study enrollment * Life expectancy of at least one year * Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable Exclusion Criteria: * Presence of visual impairment to an extent that the patient is unable to complete the computer testing * Contraindication to MRI scan (i.e. due to cardiac pacemaker) Cohort 3 (20 patients will be enrolled to this cohort. This may include some or all of the patients enrolled to Cohort 1) Inclusion Criteria * Between 4 and 18 years of age, inclusive * Previous diagnosis of a posterior fossa brain tumor * Clinical diagnosis of post-operative posterior fossa syndrome * Inability to complete NIH Toolbox * Life expectancy of at least one year * Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable Exclusion Criteria * Contraindication to MRI scan (i.e. due to cardiac pacemaker) Cohort 4 (50 Patients will be enrolled to Cohort 4. This will include patients previously enrolled on Cohorts 1-3 above.) Inclusion Criteria * Between 12-30 years of age, inclusive * Diagnosis of a brain tumor \>3 years prior to study enrollment * Life expectancy of at least one year * Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable * Patient must be able to complete a 1 hour MRI scan without sedation Exclusion Criteria * Contraindiciation to MRI scan (i.e. due to cardian pacemaker) * Presence of dental braces or programmable shunt * Patient requires sedation for MRI scan
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Perkins, M.D. — Washington University School of Medicine
- Study coordinator: Stephanie Perkins, M.D.
- Email: sperkins@wustl.edu
- Phone: 314-273-2931
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.