CURATE.AI COR-Tx Trial for Post Brain Radiotherapy Patients
NCT ID: NCT04848935
Last Updated: 2021-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2021-06-14
2022-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CURATE.AI
A cognitive evaluation and a Digital Diagnostic (DD) session performed anytime before radiotherapy will serve as the baseline. After the radiotherapy treatment, which can last between 1 to 6.5 weeks, patients will have a variable recovery time (0 to 4 weeks). Subsequently, patients will be subject to a cognitive evaluation and a DD session, right before starting the Digital Intervention (DI) training. This training will comprise ten weeks of DI (three 10-15 minute sessions per week). Patients will complete cognitive evaluations and DD sessions at the end of DI, and 16 and 32 weeks after the end of DI.
CURATE.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.
Interventions
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CURATE.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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
99 Years
ALL
No
Sponsors
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National University of Singapore
OTHER
The N.1 Institute for Health (N.1)
OTHER
National University Hospital, Singapore
OTHER
Responsible Party
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Radiation Oncology
Principal Investigator
Principal Investigators
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Dr Balamurugan A Vellayappan
Role: PRINCIPAL_INVESTIGATOR
National University of Singapore
Locations
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National University Hospital
Singapore, , Singapore
The N.1 Institute for Health (N.1), NUS
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Qian Yee, Queenie Chai, Coordinator
Role: primary
Fatin Aliyah, Coordinator
Role: backup
Xavier Tadeo, PhD
Role: primary
Yoong Hun Ong, MSc
Role: backup
References
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Kee, Theodore & Weiyan, Chee & Blasiak, Agata & Chong, Jordan & Chen, Jonna & Yeo, B.T. Thomas & Ho, Dean & Asplund, Christopher. (2019). Harnessing CURATE.AI as a Digital Therapeutics Platform by Identifying N-of-1 Learning Trajectory Profiles. Advanced Therapeutics. 2. 1900023. 10.1002/adtp.201900023.
Zarrinpar A, Lee DK, Silva A, Datta N, Kee T, Eriksen C, Weigle K, Agopian V, Kaldas F, Farmer D, Wang SE, Busuttil R, Ho CM, Ho D. Individualizing liver transplant immunosuppression using a phenotypic personalized medicine platform. Sci Transl Med. 2016 Apr 6;8(333):333ra49. doi: 10.1126/scitranslmed.aac5954.
Pantuck AJ, Lee DK, Kee T, Wang P, Lakhotia S, Silverman MH, Mathis C, Drakaki A, Belldegrun AS, Ho CM, Ho D. Modulating BET bromodomain inhibitor ZEN-3694 and enzalutamide combination dosing in a metastatic prostate cancer patient using CURATE. AI, an artificial intelligence platform. Advanced Therapeutics. 2018 Oct;1(6):1800104.
Remus A, Tadeo X, Kai GNS, Blasiak A, Kee T, Vijayakumar S, Nguyen L, Raczkowska MN, Chai QY, Aliyah F, Rusalovski Y, Teo K, Yeo TT, Wong ALA, Chia D, Asplund CL, Ho D, Vellayappan BA. CURATE.AI COR-Tx platform as a digital therapy and digital diagnostic for cognitive function in patients with brain tumour postradiotherapy treatment: protocol for a prospective mixed-methods feasibility clinical trial. BMJ Open. 2023 Oct 24;13(10):e077219. doi: 10.1136/bmjopen-2023-077219.
Other Identifiers
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2020/00249
Identifier Type: -
Identifier Source: org_study_id