CURATE.AI Optimised Digital COgnitive Rehabilitation Therapy (COR-Tx) for Post Brain Radiotherapy Patients: CURATE.AI COR-Tx Mixed-methods Feasibility Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Patient acceptability of the digital cognitive test battery DI/DD obtained during a semi-structured interview
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >21 years.
- •ECOG performance status 0 to
- •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.
排除标准
- •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.
结局指标
主要结局
Patient acceptability of the digital cognitive test battery DI/DD obtained during a semi-structured interview
时间窗: One 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 attrition rate to the DI/DD
时间窗: up to 12 months
Percentage of patients that drop out of DI/DD
Digital diagnostic limited efficacy
时间窗: up to 12 months
Correlation between standard of care cognitive evaluations scores and digital diagnostic scores
Percentage of CURATE.AI profiles successfully created and applied
时间窗: up to 12 months
Timely delivery of DI/DD at indicated time points
时间窗: up to 12 months
Percentage of DI/DD sessions successfully delivered by study team at indicated time points
Patient adherence to the DI/DD
时间窗: up to 12 months
Percentage of completed DI/DD sessions
Digital intervention limited efficacy
时间窗: up to 12 months
Change in cognitive performance as measured by the standard of care cognitive evaluations pre-post digital intervention
次要结局
- 1. Usability of the digital cognitive test battery DI/DD obtained during a semi-structured interview(One visit 60 minutes (at the end of the 10 week intervention))
研究者
Radiation Oncology
Principal Investigator
National University Hospital, Singapore