Observational Study of Neurocognitive Function in Neuro-Oncology Patients

This observational study is looking at how a neurocognitive function app, called Brainlab Cognition, can be used in a cancer clinic setting. It also aims to see if electronic surveys can effectively collect information about patients' quality of life. You may be able to join if you are an adult (18+) with a central nervous system (CNS) tumor, including primary brain tumors or brain metastases, and are receiving treatment like radiation, surgery, or chemotherapy at Miami Cancer Institute (MCI). The study will measure changes in your learning and memory, attention, speed of processing, and verbal fluency over time, up to 24 months. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 200 participants. It is not a treatment study but rather observes how an app and electronic surveys are used in a clinic.
What's involved
You would use the Brainlab Cognition app, which takes about 15 minutes to complete. Your neurocognitive function will be assessed at baseline, 2, 4, 6, 12, 18, and 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in neurocognitive function for up to 24 months after starting the study.

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NCT05504681

Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic

Recruiting
Not specifiedAges 18+Observational
Baptist Health South Florida
~200 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Observational study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Learning and memory (Neurocognitive Decline)
Measured over Baseline, 2, 4, 6, 12, 18, 24 months
+4 more outcomes measured
Neurocognitive Disorders
1 sites across 1 states
Florida1
  • Rupesh R Kotecha, MD · PRINCIPAL_INVESTIGATOR · Miami Cancer Institute

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  • Change in Learning and memory (Neurocognitive Decline)Baseline, 2, 4, 6, 12, 18, 24 months

    Learning and memory will be assessed by the number of correct responses (the total number of words correctly recalled). The "Verbal Recall" test will be used to measure the number of correct responses over 3 trials, the "Verbal Revision" will be used to measure the number of total correct responses, and the "Verbal Recognition" test will be used to measure number of correct responses minus the incorrect responses. Change is calculated as baseline score subtracted from post-baseline score over time.

  • Change in Attention and Speed of Processing (Neurocognitive Decline)Baseline, 2, 4, 6, 12, 18, 24 months

    This will be measured by the "Symbols Matching" test. Subjects will be asked to match symbols and corresponding numbers during 90 seconds. The score will be calculated by totaling the number of correct answers during the allotted time. A higher score indicates better functioning.

  • Change in Verbal Fluency (Neurocognitive Decline)Baseline, 2, 4, 6, 12, 18, 24 months

    This will be measured by the "Words That Start With" test. The total number of words correctly generated (no numbers, no proper names) by the subject will be recorded to generate their score. A higher score indicates better functioning.

  • Change in Fine motor and speed (Neurocognitive Decline)Baseline, 2, 4, 6, 12, 18, 24 months

    This will be measured by the "Numbers Ordering" test. This test assesses visual scanning and motor tracking requiring focused attention. Subjects are required to sequentially connect numbered dots in ascending order that are randomly scattered on the screen in consecutive order. The total time in seconds to complete the array will be recorded as the score result. A lower score indicates better functioning.

  • Change in Executive functions (Neurocognitive Decline).Baseline, 2, 4, 6, 12, 18, 24 months

    This will be measured by "Numbers and Letters Ordering" test. This test includes a divided attention component requiring mental flexibility (i.e., executive function). On this subtest, dots with numbers and letters are randomly scattered. Subjects are required to alternate between connecting numbers and letters in an ascending sequential order. Subjects will order numbers and letters from 1 to 13 and from A to M by tapping them as fast as possible in consecutive and alternating order. The total time in whole seconds to complete the array will be recorded. A lower score indicates better functioning.