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NCT Number: NCT05504681

Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic

This is prospective observational registry study that will assess 1) if the neurocognitive function app (Brainlab Cognition) can be used in a widespread neuro-oncology clinic setting and 2) if patient reported quality of life parameters can be obtained electronically and integrated into clinic.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location status: Recruiting

Location contact

Rupesh Kotecha

CONTACT

[email protected]

786-596-2000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult (18+) patients with central nervous system (CNS) tumors, both primary brain malignancies and brain metastases, treated with radiotherapy (partial brain, stereotactic radiosurgery, stereotactic fractionated radiotherapy, or whole-brain radiotherapy), surgery, and/or antineoplastic therapy and followed thereafter at Miami Cancer Institute (MCI)
  • Life expectancy ≥ 6 months
  • Willingness to participate in ongoing registration study

Exclusion criteria

  • Patients receiving radiotherapy to the brain for functional disease (arteriovenous malformations, trigeminal neuralgia, essential tremors, etc.)
  • Pediatric patients (<18 years old), pregnant women, and prisoners.

Treatment and study plan

observational study

Other

It takes the patient on average 15 minutes to complete the Brainlab Cognition app.

Primary outcomes

  1. Change in Learning and memory (Neurocognitive Decline)

    Time frame: 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.

  2. Change in Attention and Speed of Processing (Neurocognitive Decline)

    Time frame: 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.

  3. Change in Verbal Fluency (Neurocognitive Decline)

    Time frame: 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.

  4. Change in Fine motor and speed (Neurocognitive Decline)

    Time frame: 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.

  5. Change in Executive functions (Neurocognitive Decline).

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rupesh R Kotecha

CONTACT

[email protected]

17865962000

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Collaborators

  • Brainlab AG

Registry information

Important dates

Study start
2021
Primary completion
2030
Study completion
2032
First posted
Aug 17, 2022
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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