Trials / Active Not Recruiting
Active Not RecruitingNCT03208387
Understanding the Late Effects of Surviving a Pediatric Brain Tumor
Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 42 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 6 Years – 16 Years
- Healthy volunteers
- —
Summary
The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Diffusion tensor imaging (DTI) | DTI quantifies the degree to which water diffuses in different directions through a given brain region. The use of DTI as an in vivo index of the integrity of white matter has been applied to many disease states using several proprietary and open-source software programs (e.g. FSL 5.0). DTI tractography, employed via toolboxes such as Probtrackx within the FSL 5.0, allows the identification of white matter tracts connecting cortical and subcortical regions of interest. Furthermore, structural connectivity as measured with DTI does not duplicate functional connectivity as measure with rs-fcMRI, but rather provides complimentary perspectives. |
| DIAGNOSTIC_TEST | Resting state functional connectivity MRI (rs-fcMRI) | rs-fcMRI is a relatively new neuroimaging technique that has been applied to studying multiple clinical populations including ADHD, schizophrenia, major depressive disorder, and other neurological disorders. The approach exploits measurement of changes in brain blood oxygenation (BOLD) as is employed in task based functional MRI (measuring changes in focal cortical vascular oxygenation when engaged in a defined task, e.g. motor movement). Neuroimaging data will be collected as soon as possible (can be the same day), for up to 6 weeks. |
| BEHAVIORAL | Wechsler Intelligence Scale for Children - 5th edition (WISC-V) | Will gather IQ data and is the gold standard for IQ assessment for those between the ages of 6:0 and 16:11 years. |
| BEHAVIORAL | California Verbal Learning Test (CVLT-C) | Validated measure of verbal learning and memory for those between the ages of 5:0 and 16:11. |
| BEHAVIORAL | Beery Test of Visual Motor Integration 6th edition | Measure designed to assess visual-motor functioning of subjects between the ages of 2-99 years old by copying designs using paper and pencil. |
| BEHAVIORAL | Grooved Pegboard | This is a standard assessment of fine motor functioning and dexterity by asking the subject to place metal pegs into holes on a board. |
| BEHAVIORAL | PedsQL Multidimensional Fatigue Scale | Designed to measure fatigue in pediatric patients (ages 5-17 years) and is comprised of the General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items) and Cognitive Fatigue Scale (6 items). |
| DIAGNOSTIC_TEST | MRI | Images will be acquired on a 3.0 Tesla MRI scanner at each of the four study sites. At MSK, resting state fMRI data will be obtained using a 3T GE scanner with an 8-channel head coil (Discovery 750w DV25) |
Timeline
- Start date
- 2017-06-28
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2017-07-05
- Last updated
- 2025-09-12
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03208387. Inclusion in this directory is not an endorsement.