Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic

Recruiting

• Conditions: Neurocognitive Disorders

• Registration Number: NCT05504681
• Lead Sponsor: Baptist Health South Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-30
• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. 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)
2. Life expectancy ≥ 6 months
3. Willingness to participate in ongoing registration study

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 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.
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.

Trial Locations

Locations (1)

Miami Cancer Institute; 🇺🇸 Miami, Florida, United States