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CURATE.AI COR-Tx Trial for Post Brain Radiotherapy Patients

CURATE.AI Optimised Digital COgnitive Rehabilitation Therapy (COR-Tx) for Post Brain Radiotherapy Patients: CURATE.AI COR-Tx Mixed-methods Feasibility Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04848935
Enrollment
15
Registered
2021-04-19
Start date
2021-06-14
Completion date
2022-07-01
Last updated
2021-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline

Keywords

Oncology, Digital therapeutics, Cognitive evaluation, Digital diagnostic, Cognitive training, Phenotypic Personalised Medicine (PPM), Multi-Attribute Task Battery (MATB), Training intensity, Radiotherapy, CURATE.AI

Brief summary

Cognitive deficit is common in patients who have undergone whole brain or partial brain radiotherapy. To counteract intellectual deterioration, the conventional strategies includes drug- based treatments such as donezepil and memantine, which have shown to only provide marginal improvement and, cognitive training regimens, both of which are usually administered at fixed dose/intensities often leading to sub-optimal responses. This study aims to address this clinically relevant problem by harnessing the CURATE.AI platform to identify N-of-1cognitive training profiles the can enhance learning trajectories through individualised calibration and training regimens. CURATE.AI is a phenotypic personalised medicine (PPM) platform that correlates a patient's phenotypic response (cognitive performance) to a certain input (training intensity) based exclusively on the patient's data. This PPM platform is independent of biological system or interventional agent and can be applied to any disorder treatment where dosing/intensity could be better personalised. CURATE.AI is expected to optimise/personalise cognitive training in post-brain radiotherapy patients by dynamically modulating the intensity of a digital cognitive test battery that measures executive processing, multitasking and perceptual learning tasks. In addition, this clinical feasibility trial aims to assess this cognitive test battery as a potential analogous or complementary diagnostic tool as compared to traditional cognitive evaluations performed by a clinician.

Detailed description

Brain radiotherapy causes downstream cognitive deficits. Drug-based cognitive decline treatments show little improvement and side effects may reduce patient compliance. Regimens are usually administered at a fixed dose that doesn't incorporate high patient variability, leading to sub-optimal responses. Effective cognitive training can improve cognitive performance. Artificial intelligence platforms show great potential for training personalisation. The CURATE.AI platform can be used to identify N-of-1 (single subject) training profiles that can be used to optimise learning trajectories through individualised calibration and training regimens, potentially leading to improved outcomes compared to standard static or adaptive training strategies. CURATE.AI uses only a subject's own performance data to identify the intensity needed for his/her best output. As the subject evolves during the course of intervention, the training intensities are dynamically modulated to maintain performance within a given range. Here the investigators propose to test the feasibility of CURATE.AI, with a digital cognitive test battery as the interface, as an adaptive training platform for cognitive training addressed to improve brain cancer radiotherapy patients' cognitive performance. The acceptability, implementation and limited efficacy of the digital intervention (DI) will be explored. In addition, the investigators propose to test the feasibility of the digital cognitive test battery potential as a digital diagnostic (DD) tool as compared to traditional cognitive evaluations performed by a clinician. User experience and usability will also be explored.

Interventions

DEVICECURATE.AI

CURATE.AI will be utilised to provide personalised training intensity recommendations (low, medium or high) to the patients during the digital cognitive test battery DI session. The difficulty of each task will be modulated by CURATE.AI by adjusting the frequency of critical events that demand evaluation and/or response.

Sponsors

National University of Singapore
CollaboratorOTHER
The N.1 Institute for Health (N.1)
CollaboratorOTHER
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Age \>21 years. * ECOG performance status 0 to 2. * Patients with a neoplastic condition (benign or malignant) involving the brain or skull requiring radiotherapy (with or without chemotherapy). * Patients with a life expectancy of at least 6 months.

Exclusion criteria

* Pregnant or breastfeeding women. * Patients undergoing stereotactic radiosurgery (single fraction). * Patients who are undergoing re-irradiation to the same area of the brain. * Patients physically incapable of using computer tablet (either due to vision loss or dominant hand weakness) * Patients who cannot understand spoken English language. * Patients who are unable to give informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Digital diagnostic limited efficacyup to 12 monthsCorrelation between standard of care cognitive evaluations scores and digital diagnostic scores
Patient acceptability of the digital cognitive test battery DI/DD obtained during a semi-structured interviewOne visit 60 minutes (at the end of the 10 week intervention)Qualitative summary of patient acceptability of the digital cognitive test battery DI/DD
Patient adherence to the DI/DDup to 12 monthsPercentage of completed DI/DD sessions
Patient attrition rate to the DI/DDup to 12 monthsPercentage of patients that drop out of DI/DD
Percentage of CURATE.AI profiles successfully created and appliedup to 12 months
Timely delivery of DI/DD at indicated time pointsup to 12 monthsPercentage of DI/DD sessions successfully delivered by study team at indicated time points
Digital intervention limited efficacyup to 12 monthsChange in cognitive performance as measured by the standard of care cognitive evaluations pre-post digital intervention

Secondary

MeasureTime frameDescription
1. Usability of the digital cognitive test battery DI/DD obtained during a semi-structured interviewOne visit 60 minutes (at the end of the 10 week intervention)Qualitative summary of patient usability of the digital cognitive test battery DI/DD

Countries

Singapore

Contacts

Primary ContactDr Balamurugan A Vellayappan
bala_vellayappan@nuhs.edu.sg+65 67795555
Backup ContactQian Yee, Queenie Chai
queenie_qy_chai@nuhs.edu.sg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026