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Cognitive DeclineNCT05163769

Physical and Cognitive Training System for Neurocognitive Protection and Enhancement in Older Adults

A study testing NeeuroCycle Physical and Cognitive Training System and NeeuroCycle Cognitive Training System in people with Cognitive Decline, run by Duke-NUS Graduate Medical School at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Decline
What is being tested?
NeeuroCycle Physical and Cognitive Training System and NeeuroCycle Cognitive Training System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
237 participants
Where
1 siteSingapore
Study dates
17 May 2022to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site, 1 recruiting
  • Duke-NUS Graduate Medical School

    Singapore, 169857

    Melissa Ng, +65 65161766, melissa.ng@duke-nus.edu.sg

    Tih Shih Lee, MD, PhD

    Recruiting

Other trials in Singapore

About this study

Official title: The Efficacy of a Novel Multimodal Personalized Physical and Cognitive Training System for Neurocognitive Protection and Enhancement in Older Adults

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.

Read the detailed description

Neurocognitive decline is a health problem that is associated with ageing. More often than not, age-related cognitive decline may be indicative of the onset of mild cognitive impairment (MCI), or even more severe neurocognitive disorders such as Alzheimer's and Parkinson's disease-both of which will eventually lead to dementia. Cognitive decline and neurocognitive disorders can often lead to the gross deterioration in one's quality of life. Depending on the severity and duration of the onset of the neurocognitive decline, patients may experience anything from forgetfulness or learning difficulties, to major issues such as a decreased capacity for decision-making, confusion, disorientation, communication problems, and social behavioral issues. All of these issues could impede one's ability to care for one's self, which may also lead to the increased reliance and burden on caretakers.

On a global scale, it is estimated that about 46.8 million people suffer from dementia or other dementia subtypes. That number is expected to increase by 68% over the next 30 years. The current economic burden of dementia and other dementia subtypes is evaluated at $818 billion, with projections expecting cost to rise to $2 trillion by the year 2030. In Singapore specifically, the estimated cost of dementia was reported at $1.4 billion per year, with costs expecting to rise in tandem with Singapore's rapidly aging population. Given the impact and impending threats of neurocognitive decline, it is clear that intentional efforts to combat neurocognitive decline is necessary.

To date, experts in the field have yet to identify specific causes of neurocognitive decline. This is due to the heterogeneity of neurocognitive decline and the diseases associated with it. As such, it has been challenging to find definitive causes and cures for neurocognitive decline. That said, there are several risk factors associated with neurocognitive decline and dementia. Risk factors such as age and genetics are fairly predictive of neurocognitive decline, but are, by nature, unmodifiable. However, risk factors such as, but not limited to, cardiovascular problems, physical activity, cognitive training, and social engagement are possible and much easier to modify. Hence, there has been a preponderance of interventions in the field that targets those specific modifiable risk factors with the intention of manipulating current or future neurocognitive outcomes. For example, cognitive training (CT) has been a target for interventions that promote the delay and/or prevention of neurocognitive decline. Over the past few decades, CT programs in the field have evolved to computerized, gamified, and self-manned versions that usually target specific areas of cognition such as memory, attention, decision-making, inhibition, or a combination of those areas.

Similarly, physical activity (PA) has also been a target for interventions that promote the delay and/or prevention of neurocognitive decline. Studies with PA-specific interventions have also shown to positively influence neurocognitive function in patients with mild cognitive impairment, as well as those who are at risk of developing Alzheimer's Disease. Evidence also show that PA can delay the effects of neurocognitive decline in patients with existing cognitive decline, dementia, and other dementia subtypes.

Interestingly, there has been a recent surge of interventions in the field that amalgamates both PA and CT elements. This shift in direction in the field acknowledges the symbiotic relationship between CT and PA with regards to neurocognitive outcome. Many of these studies set out to investigate the effects of 'exergaming' (a portmanteau of exercise and gaming) on neurocognitive function in the older adult population with varying neurocognitive capacity ranging from healthy to declining. Exergaming interventions have shown to improve the subjects' executive function and cognitive performance after the intervention period as compared to the subject controls. The effects of exergaming interventions were also able to delay the onset of mild cognitive impairment in healthy subjects as compared to the healthy controls in some studies. That said, such programs are still limited by factors such as poor personalization capabilities, substandard controls, and high attrition rates (lack of participant engagement). Additionally, studies of such nature are far and few between in Asia, making it unclear if similar results can be replicated in an Asian-majority demographic like Singapore.

To address these issues, the current study aims to use a novel personalized multimodal physical and cognitive brain computer interface (BCI) training system to delay and/or prevent neurocognitive decline, and enhance neurocognitive function. The investigators' proposed training system integrates a stationary cycling intervention and a corresponding personalized BCI cognitive training program. The BCI cognitive training program uses machine learning technologies and elderly-friendly user-interface/user-experience (UI/UX) game design to actively track individual neurocognitive status, provide feedback in real-time, and encourage older adults to persist in training for the long term. The investigators also seek to customize the program's UI/UX by employing locally-relevant materials to reduce accessibility barriers and increase participant engagement. For the purposes of this study, all instructions and interventions will be delivered in English. However, there are plans for future iterations of this program to include other local languages to facilitate the use of the program by non-English speaking Singaporean elderly.

Being tested
NeeuroCycle Physical and Cognitive Training System, NeeuroCycle Cognitive Training System
Keywords
Cognitive Decline, Cognitive Training, Physical Training, Exergaming, Personalized, Older Adults
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeeuroCycle Physical and Cognitive Training SystemDevice

    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.

  • NeeuroCycle Cognitive Training SystemDevice

    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.

Study groups in NCT05163769
Study groupRoleWhat they receive
Multimodal TrainingExperimentalThe 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.
Receives: Device: NeeuroCycle Physical and Cognitive Training System
Neurocognitive-Training onlyExperimentalThe 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.
Receives: Device: NeeuroCycle Cognitive Training System
Active ControlNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Number of Adverse Events/Serious Adverse Events Reported

    To record the number of adverse events/serious adverse events reported.

    Measured: Throughout the intervention period (Up to 24 weeks) for all three study arms.

  2. Systems Usability Scale

    Participants will rate their agreeableness on 10 statements regarding their satisfaction and ease of use of the training components on a 5-point Likert scale. Participants will also answer three qualitative questions regarding their satisfaction and ease of use.

    Measured: Two intervention groups(mBCI and nBCI): Post-intervention(Week 24; Session 48)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start17 May 2022
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
237 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05163769
Sponsor's protocol ID
2021-591
Status last verified
Jul 2022
First submitted
7 Dec 2021
Last updated
28 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing NeeuroCycle Physical and Cognitive Training System and NeeuroCycle Cognitive Training System in people with Cognitive Decline, run by Duke-NUS Graduate Medical School at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Melissa Ng, BSc (+65 90272218, melissa.ng@duke-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Repeatable Battery for the Assessement Neuropsychological Status (RBANS) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.

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