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.
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
- Type of treatment
- Pill or oral medicine, Medical device
- 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
- Recruiting
Duke-NUS Graduate Medical School
Singapore, 169857
Melissa Ng, +65 65161766, melissa.ng@duke-nus.edu.sg
Tih Shih Lee, MD, PhD
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.
- Conditions
- Cognitive Decline
- 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 group | Role | What they receive |
|---|---|---|
| Multimodal Training | Experimental | The 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 only | Experimental | The 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 Control | No intervention | The 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.
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)
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.
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.
- First posted20 Dec 2021
- Study start17 May 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University, Tan Tock Seng Hospital
- Responsible party
- Principal investigator, Lee Tih Shih, Duke-NUS Graduate Medical School
- Investigators
- Tih Shih Lee, MD/PhD, Principal investigator, Duke-NUS Graduate Medical School
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Novel Multimodal Personalized Physical and Cognitive Training System for Neurocognitive Protection and Enhancement in Older Adults
- ClinicalTrials.gov ID
- NCT05163769
- Acronym / sponsor ID
- 2021-591
- Conditions
- Cognitive Decline
- Keywords
- Cognitive Decline, Cognitive Training, Physical Training, Exergaming, Personalized, Older Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- Nanyang Technological University, Tan Tock Seng Hospital
- Study start
- 17 May 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multimodal Training | Experimental | Device: NeeuroCycle Physical and Cognitive Training SystemThe 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 | Experimental | Device: NeeuroCycle Cognitive Training SystemThe 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 intervention | –The 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeeuroCycle Physical and Cognitive Training SystemThe 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. | Device | Multimodal Training |
| NeeuroCycle Cognitive Training SystemThe 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. | Device | Neurocognitive-Training only |
Primary outcome
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.
The RBANS test provides reliable and well-validated assessments of five different cognitive domains including: language, attention, visuospatial awareness, immediate, and delayed memory.
2 secondary outcomes
Number of Adverse Events/Serious Adverse Events Reported
Time frame: Throughout the intervention period (Up to 24 weeks) for all three study arms.
Systems Usability Scale
Time frame: Two intervention groups(mBCI and nBCI): Post-intervention(Week 24; Session 48)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
Related trials for Cognitive Decline
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tih Shih Lee, MD/PhD principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
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.