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Cognitive Testing + Brain Imaging for Childhood Brain Cancer

Q: How many participants are currently engaged in this clinical research?

Affirmative. Evidentiary information hosted on clinicaltrials.gov suggests that this study is actively seeking participants, with the initial posting being made on October 26th 2016 and last updated April 5th 2022. 200 people are required to be recruited from a single location.

Q: Is it possible for me to join this medical experiment?

Participants aged between 4 and 18 who have been diagnosed with <a href="https://www.withpower.com/clinical-trials/brain-cancer">brain cancer</a> are eligible to join this trial. This medical research is hoping to recruit a total of 200 volunteers.

Q: Are geriatric participants eligible for the examination?

Only those aged between 4 and 18 are permitted to join this trial. The database of clinical trials features 77 studies concerning minors, while there is 344 for older adults.

Q: Is this clinical study still open to participants?

Clinicaltrials.gov reveals that recruitment for this research-based project is underway; the trial was first published on October 26th, 2016 and has been modified most recently on April 5th 2022.

N/A

Recruiting

Led By Josh Rubin, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 1: Between 4 and 18 years of age, inclusive, with newly diagnosed primary brain tumor of any location and any histology, having a life expectancy of at least one year, and able to understand and willing to consent or assent to the research proposed, along with consent of legal guardian(s) if applicable

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 27 months

Awards & highlights

Study Summary

This trial will focus on three groups of brain tumor patients aged 4-18 to see if cognitive function can be predicted using imaging and cognitive testing.

Who is the study for?

This trial is for children aged 4-18 with new brain tumors, focusing on those with posterior fossa tumors or related syndromes. Participants need a life expectancy of at least one year and must consent along with their guardians.Check my eligibility

What is being tested?

The study aims to collect data on cognitive function using neurocognitive tests and resting-state functional MRI (rsfcMRI) in kids during diagnosis and treatment to predict cognitive outcomes.See study design

What are the potential side effects?

There are no direct side effects from the interventions being studied as they involve non-invasive testing methods like brain scans (rsfcMRI) and cognitive assessments rather than medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 4 and 18 years old with a new brain tumor diagnosis and expected to live at least one more year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Identify reliable peri-diagnostic estimators of brain function as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data

Identify reliable peri-diagnostic estimators of brain function as measured by neurocognitive testing

Identify reliable peri-diagnostic estimators of cognition as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data

+2 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 4 Arm BExperimental Treatment2 Interventions

During standard of care MRI images, rsfcMRI imaging will be performed which will add 15 minutes of scan time. Will complete cognitive testing using the NIH Toolbox Cognitive Battery All patients will complete the Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale - 5 questionnaire. All patients will complete a self-reported assessment of neurological quality of life (QOL). Adult patients (age ≥ 18 years) will complete the adult version of the Quality of Life in Neurological Disorders (Neuro-QOL) Cognitive Function measure. All pediatric patients will complete the pediatric version of the Neuro-QOL Cognitive Function measure. For patients <18 years of age and for adult patients with parent present, parent/caregiver will complete the PROMIS® Parent Proxy for cognition. All adult patients will complete the Colorado Learning Difficulties Questionnaire (CLDQ). This questionnaire will be completed by parent/caregiver for patients < 18 years of age.

Group II: Cohort 4 Arm AExperimental Treatment2 Interventions

Undergo the following MRI images: RSFC MRI, T2/T1 MRI, and DTI. Will complete cognitive testing using the NIH Toolbox Cognitive Battery All patients will complete the Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale - 5 questionnaire. All patients will complete a self-reported assessment of neurological quality of life (QOL). Adult patients (age ≥ 18 years) will complete the adult version of the Quality of Life in Neurological Disorders (Neuro-QOL) Cognitive Function measure. All pediatric patients will complete the pediatric version of the Neuro-QOL Cognitive Function measure. For patients <18 years of age and for adult patients with parent present, parent/caregiver will complete the PROMIS® Parent Proxy for cognition. All adult patients will complete the Colorado Learning Difficulties Questionnaire (CLDQ). This questionnaire will be completed by parent/caregiver for patients < 18 years of age.

Group III: Cohort 3Experimental Treatment1 Intervention

During standard of care MRI images, rsfcMRI imaging will be performed which will add 15 minutes of scan time. rsfcMRI will be obtained annually for total of 3 rsfcMRIs for each patient.

Group IV: Cohort 2Experimental Treatment2 Interventions

Patients with diagnosis of a posterior tumor will undergo neurocognitive testing utilizing the NIH Toolbox. Testing will be every 6 months for children currently receiving therapy and annually for those that have completed all therapy for a total of 3 sessions. During standard of care MRI images, rsfcMRI imaging will be performed which will add 15 minutes of time. rsfcMRI will be obtained every 6 months for children currently receiving therapy and annually for those that have completed therapy for a total of 3 rsfcMRIs for each patient. Patients in Cohort 1 will also be eligible to continue with the longitudinal assessment as just described. These participants will then undergo repeat neurocognitive testing using the NIH toolbox 6-9 months for an additional 3 testing sessions. rsfcMRI will be obtained during their follow-up imaging at 6-9 month intervals for a total of 3 additional rsfcMRIs (4 total scans).

Group V: Cohort 1Experimental Treatment2 Interventions

Prior to surgery, subjects will have a complete standard of care history and physical exam by the neurosurgeon and then undergo peri-diagnostic neurocognitive testing utilizing the NIH Toolbox Cognitive Battery computer testing software for iPad (will take 45 minutes). The peri-diagnostic period will be defined as the period from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later. Participants will also undergo a rsfcMRI during their standard of care MRI imaging which will add 15 minutes to their scan time

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Discovery InstituteUNKNOWN

4 Previous Clinical Trials

275 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,554 Total Patients Enrolled

Neurosurgery Research & Education FoundationUNKNOWN

Media Library

Neurocognitive testing Clinical Trial Eligibility Overview. Trial Name: NCT02914067 — N/A

Neurocognitive testing 2023 Treatment Timeline for Medical Study. Trial Name: NCT02914067 — N/A

Childhood Brain Tumors Research Study Groups: Cohort 1, Cohort 2, Cohort 3, Cohort 4 Arm A, Cohort 4 Arm B

Childhood Brain Tumors Clinical Trial 2023: Neurocognitive testing Highlights & Side Effects. Trial Name: NCT02914067 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently engaged in this clinical research?

"Affirmative. Evidentiary information hosted on clinicaltrials.gov suggests that this study is actively seeking participants, with the initial posting being made on October 26th 2016 and last updated April 5th 2022. 200 people are required to be recruited from a single location."

Answered by AI

Is it possible for me to join this medical experiment?

"Participants aged between 4 and 18 who have been diagnosed with brain cancer are eligible to join this trial. This medical research is hoping to recruit a total of 200 volunteers."

Answered by AI

Are geriatric participants eligible for the examination?

"Only those aged between 4 and 18 are permitted to join this trial. The database of clinical trials features 77 studies concerning minors, while there is 344 for older adults."

Answered by AI

Is this clinical study still open to participants?

"Clinicaltrials.gov reveals that recruitment for this research-based project is underway; the trial was first published on October 26th, 2016 and has been modified most recently on April 5th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cognitive Biomarkers in Pediatric Brain Tumor Patients

2016. "Cognitive Biomarkers in Pediatric Brain Tumor Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02914067.

All > Brain Tumor