Physical and Cognitive Training System for Neurocognitive Protection and Enhancement in Older Adults
The Efficacy of a Novel Multimodal Personalized Physical and Cognitive Training System for Neurocognitive Protection and Enhancement in Older Adults
1 other identifier
interventional
237
1 country
1
Brief Summary
Neurocognitive decline is a health issue that is associated with ageing. It is often irreversible from the onset. The concomitant costs of neurocognitive decline could be potentially exponential if left unchecked. Therefore, there is a need to be able to delay the onset of age-related neurocognitive decline or possibly avoid it altogether. Previous studies have shown that there is a strong positive relationship between the fitness of neurocognitive function and cognitive training. More interestingly, recent studies also suggest that combining cognitive training with physical activity may result in a better outcome for neurocognitive function as compared to only cognitive training. Anchoring on the findings of those studies, the investigators aim to develop and evaluate the efficacy of a novel personalized multimodal brain computer interface (BCI) cognitive and physical training system for neurocognitive protection and enhancement in older adults. The current study employs a three-arm randomized-controlled trial approach. The investigators hypothesize that participants in the multimodal cognitive and physical training (mBCI) group will perform significantly better than the cognitive training-only BCI (nBCI) and active control (AC) groups on the Repeated Battery for the Assessment of Neuropsychological Status (RBANS) after an initial high-intensity 36 training session period from pre- to 12 weeks post-intervention. The investigators also hypothesize that the mBCI group will perform significantly better on the RBANS than nBCI or AC groups after the consecutive high- and low-intensity periods from pre- to 24-weeks post-intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2021
CompletedFirst Posted
Study publicly available on registry
December 20, 2021
CompletedStudy Start
First participant enrolled
May 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedJuly 28, 2022
July 1, 2022
1.4 years
December 7, 2021
July 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Repeatable Battery for the Assessement Neuropsychological Status (RBANS)
The RBANS test provides reliable and well-validated assessments of five different cognitive domains including: language, attention, visuospatial awareness, immediate, and delayed memory.
Comparison in the change of RBANS total score from pre-treatment (Week 1; Session 1) to mid-treatment (Week 12; Session 36) to post-treatment (Week 24; Session 48) among all three study arms.
Secondary Outcomes (2)
Number of Adverse Events/Serious Adverse Events Reported
Throughout the intervention period (Up to 24 weeks) for all three study arms.
Systems Usability Scale
Two intervention groups(mBCI and nBCI): Post-intervention(Week 24; Session 48)
Study Arms (3)
Multimodal Training
EXPERIMENTALThe participants in the Multimodal training arm (mBCI) will undergo 48 physical and cognitive training sessions over 24 weeks on the NeeuroCycle BCI Physical and Cognitive training system. Sessions are scheduled three times a week for the first 12 weeks and then once a week for the subsequent 12 weeks. Sessions are spaced at least one day apart and will take about one hour per session.The mBCI training program will deliver cognitive training modules in tandem with a stationary cycling regime. The cognitive training program consists of six different gamified tasks that target attention, immediate/working and delayed memory, decision-making, and visuospatial abilities delivered on an electronic tablet. The cycling regime is divided into seven non-consecutive sections. The participant will be tasked to complete a cognitive training activity that will last about 2-3 minutes between each cycling session.
Neurocognitive-Training only
EXPERIMENTALThe participants in the Neurocognitive training-only arm (nBCI) will undergo 48 cognitive training sessions over 24 weeks on the NeeuroCycle BCI Cognitive training system. The sessions are scheduled three times a week for the first 12 weeks and then once a week for the subsequent 12 weeks. Sessions are spaced at least one day apart and will take about one hour per session. The nBCI training protocol will deliver cognitive training modules that consists of six different gamified tasks that target attention, immediate/working and delayed memory, decision-making, and visuospatial abilities delivered on an electronic tablet. Participants will navigate the virtual space of the cognitive training program by using arrow keys on the tablet.
Active Control
NO INTERVENTIONThe participants in the Active Control arm (AC) will undergo 48 sessions over 24 weeks. The sessions are scheduled three times a week for the first 12 weeks and then once a week for the subsequent 12 weeks. Sessions are spaced at least one day apart and will take about one hour per session. Participants in this arm will view informative documentaries on an electronic tablet and answer three general questions about documentary.
Interventions
The NeeuroCycle Physical and Cognitive Training System is a novel multimodal electroencephalogram (EEG)-based physical and cognitive training device. The system mainly comprises of a recumbent bicycle device and a customized four frontal electrode EEG-headband paired with the gamified NeeuroCycle cognitive training program delivered via an electronic application (app) on a tablet. The cognitive training program is built upon patented EEG-based attention, learning, and memory algorithms.
The NeeuroCycle Cognitive Training System is a novel electroencephalogram (EEG)-based cognitive training device. The system mainly comprises of a customized four frontal electrode EEG-headband paired with the gamified NeeuroCycle cognitive training program delivered via an electronic application (app) on a tablet. The cognitive training program is built upon patented EEG-based attention, learning, and memory algorithms.
Eligibility Criteria
You may qualify if:
- Physically healthy adults from 50 to 75 years old.
- Mini-mental state examination (MMSE) \>= 24.
- Able to travel to study site independently.
- Literate in English.
- BMI within acceptable range (BMI scores from 18.5 to 24.9).
- Able to cycle on the NeeuroCycle recumbent bicycle device at a comfortable pace for a continuous period of three minutes without experiencing symptoms of severe breathlessness, fatigue, and pain.
- Fully vaccinated against COVID-19 (Government Approved Vaccines ONLY; at least two weeks from the date of the second vaccination)
You may not qualify if:
- Any known neuropsychiatric disorders (such as dementia, epilepsy or mental retardation).
- Presence of end stage lung, cardiac, liver, and/or renal disease.
- Experienced any cerebrovascular and/or cardiac events in the last 6 months.
- Have active arthritis.
- Uncorrected gross hearing, visual and/or speech impairments.
- Prone to vertigo, motion sickness, and/or migraine episodes.
- Highly physically active.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke-NUS Graduate Medical Schoollead
- Nanyang Technological Universitycollaborator
- Tan Tock Seng Hospitalcollaborator
Study Sites (1)
Duke-NUS Graduate Medical School
Singapore, 169857, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tih Shih Lee, MD/PhD
Duke-NUS Graduate Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 7, 2021
First Posted
December 20, 2021
Study Start
May 17, 2022
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
July 28, 2022
Record last verified: 2022-07