Recruiting

Neurocognitive Biomarkers

Sponsor:

Baptist Health South Florida

Code:

NCT05504681

Conditions

Neurocognitive Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observational study

Study Details

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.

Conditions

Neurocognitive Disorders

Study ID

NCT05504681

Start date

Nov 30, 2021

Status verified date

Apr, 2026

Completion date

Apr, 2032

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Observational study

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

Primary outcome measure

  • Change in Learning and memory (Neurocognitive Decline) [ Time Frame: Baseline, 2, 4, 6, 12, 18, 24 months ]
  • Change in Attention and Speed of Processing (Neurocognitive Decline) [ Time Frame: Baseline, 2, 4, 6, 12, 18, 24 months ]
  • Change in Verbal Fluency (Neurocognitive Decline) [ Time Frame: Baseline, 2, 4, 6, 12, 18, 24 months ]
  • Change in Fine motor and speed (Neurocognitive Decline) [ Time Frame: Baseline, 2, 4, 6, 12, 18, 24 months ]
  • Change in Executive functions (Neurocognitive Decline). [ Time Frame: Baseline, 2, 4, 6, 12, 18, 24 months ]

Central Contacts and Locations

Central contacts

Rupesh R Kotecha

17865962000rupeshk@baptisthealth.net

Locations

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Rupesh Kotecha

786-596-2000rupeshk@baptisthealth.net

More Information

Sponsor

Baptist Health South Florida

Last update posted

May 19, 2026

Last verified

Apr, 2026

Keywords

  • Neurocognitive
  • Brainlab Cognition app

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baptist Health South Florida on 2026-05-19.