Cognition Disorders in Old AgeNCT05278273
A Feasibility Trial and Protocol for Remote Cognitive Training Developed for Use in a Cognitively Healthy Adult Population During the COVID-19 Pandemic
A study testing NeurotrackerX in people with Cognition Disorders in Old Age, run by University of Victoria at 1 site in Canada.
Trial summary
The COVID-19 pandemic has created a shift in the use of at-home spaces for work, play and research. In the current study, the feasibility of implementing an at-home cognitive training tool called NeuroTrackerX, an anaglyph version of the three-dimensional multiple object tracking (3D-MOT) software NeuroTracker was… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorders in Old Age
- What is being tested?
- NeurotrackerX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2021to 10 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for both groups included being aged 50 years and older and to have either normal or corrected vision.
Who cannot join
- Exclusion criteria included the presence of any major neurocognitive disorder or the presence of visual deficits that impeded one's ability to complete the 3D task.
Trial locations and contacts
1 site in 1 country.
About this study
The COVID-19 pandemic has created a shift in the use of at-home spaces for work, play and research. In the current study, the feasibility of implementing an at-home cognitive training tool called NeuroTrackerX, an anaglyph version of the three-dimensional multiple object tracking (3D-MOT) software NeuroTracker was examined, and with the intent of developing an effective protocol and determining the suitability of this tool for research purposes .
Read the detailed description
The work looks at the feasibility of using a newly developed anaglyph 3D cognitive training tool called NeuroTrackerX in research with adult participants. The work looks to validate an at-home program by comparing participants who complete an online version of Neurotracker (NeurotrackerX) with a group of individuals who completed the classically used in-lab version (Neurotracker). Due to COVID-19, many laboratories forced to transition to remote-based studies, and the purpose of the work is to validate the remote-based protocol. Twenty cognitively healthy adults (10 Male; 10 female) were recruited to engage in this at-home program. The results of these individuals will be compared with results from a group of cognitively healthy adults who had previously engaged in the in-lab version of the program prior to the pandemic.
- Conditions
- Cognition Disorders in Old Age
- Being tested
- NeurotrackerX
- Keywords
- 3-dimensional multiple object tracking, Cognitive Training, Neurotracker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurotrackerXDevice
At-home participants loaned the necessary equipment (e.g., 3D-glasses, computer equipment) from the research facilities and engaged in 10 training sessions over five weeks (2x per week). Participant recruitment, retention, adherence and experience were used as markers of feasibility. For program validation, twenty participants above 50 years old, who had previously completed at least eight sessions of the in-lab 3D-MOT program, were randomly selected as the control group.
| Study group | Role | What they receive |
|---|---|---|
| At home cognitive training | Experimental | We recruited 20 adults (10 female, mean age = 68.3 years, SD = 6.75) as the at-home training group. We assessed cognitive health status for participants using a self-report questionnaire and the Mini-Mental State Examination (MMSE), and all participants were deemed cognitively healthy (MMSE > 26). At-home participants loaned the necessary equipment (e.g., 3D-glasses, computer equipment) from the research facilities and engaged in 10 training sessions over five weeks (2x per week). Participant recruitment, retention, adherence and experience were used as markers of feasibility. Receives: Device: NeurotrackerX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurotracker scores
Performance on the multiple-object tracking program across 10 sessions. Scores are between 0 - 4, with increasing scores indicating increasing performance.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start4 Jan 2021
- Primary completion14 Feb 2021
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognition Disorders in Old AgeStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Twenty adults (10 female, 10 male) will serve as the at-home training group. The cognitive health status for participants will be assessed using a self-report questionnaire and the Mini-Mental State Examination (MMSE), and all participants were deemed cognitively healthy (MMSE \> 26). At-home participants loaned the necessary equipment (e.g., 3D-glasses, computer equipment) from the research facilities and engaged in 10 training sessions over five weeks (2x per week). Participant recruitment, retention, adherence and experience will be used as markers of feasibility. For program validation, twenty participants above 50 years old, who had previously completed at least eight sessions of the in-lab 3D-MOT program, were randomly selected as the control group. Individual session scores, overall improvement and learning rates between groups will be compared.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Christie, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278273
- Sponsor's protocol ID
- 20-0531
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Snowden T, Ohlhauser L, Morrison J, Faubert J, Gawryluk J, Christie BR. A Protocol for Remote Cognitive Training Developed for Use in Clinical Populations During the COVID-19 Pandemic. Neurotrauma Rep. 2023 Aug 14;4(1):522-532. doi: 10.1089/neur.2023.0009. eCollection 2023.
PubMed 37645472
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial and Protocol for Remote Cognitive Training Developed for Use in a Cognitively Healthy Adult Population During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05278273
- Acronym / sponsor ID
- 20-0531
- Conditions
- Cognition Disorders in Old Age
- Keywords
- 3-dimensional multiple object tracking, Cognitive Training, Neurotracker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 14 Feb 2021 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 14 Mar 2022 (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.
The COVID-19 pandemic has created a shift in the use of at-home spaces for work, play and research. In the current study, the feasibility of implementing an at-home cognitive training tool called NeuroTrackerX, an anaglyph version of the three-dimensional multiple object tracking (3D-MOT) software NeuroTracker was examined, and with the intent of developing an effective protocol and determining the suitability of this tool for research purposes .
Detailed description
The work looks at the feasibility of using a newly developed anaglyph 3D cognitive training tool called NeuroTrackerX in research with adult participants. The work looks to validate an at-home program by comparing participants who complete an online version of Neurotracker (NeurotrackerX) with a group of individuals who completed the classically used in-lab version (Neurotracker). Due to COVID-19, many laboratories forced to transition to remote-based studies, and the purpose of the work is to validate the remote-based protocol. Twenty cognitively healthy adults (10 Male; 10 female) were recruited to engage in this at-home program. The results of these individuals will be compared with results from a group of cognitively healthy adults who had previously engaged in the in-lab version of the program prior to the pandemic.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Twenty adults (10 female, 10 male) will serve as the at-home training group. The cognitive health status for participants will be assessed using a self-report questionnaire and the Mini-Mental State Examination (MMSE), and all participants were deemed cognitively healthy (MMSE > 26). At-home participants loaned the necessary equipment (e.g., 3D-glasses, computer equipment) from the research facilities and engaged in 10 training sessions over five weeks (2x per week). Participant recruitment, retention, adherence and experience will be used as markers of feasibility. For program validation, twenty participants above 50 years old, who had previously completed at least eight sessions of the in-lab 3D-MOT program, were randomly selected as the control group. Individual session scores, overall improvement and learning rates between groups will be compared.
| Arm | Type | Receives |
|---|---|---|
| At home cognitive training | Experimental | Device: NeurotrackerXWe recruited 20 adults (10 female, mean age = 68.3 years, SD = 6.75) as the at-home training group. We assessed cognitive health status for participants using a self-report questionnaire and the Mini-Mental State Examination (MMSE), and all participants were deemed cognitively healthy (MMSE > 26). At-home participants loaned the necessary equipment (e.g., 3D-glasses, computer equipment) from the research facilities and engaged in 10 training sessions over five weeks (2x per week). Participant recruitment, retention, adherence and experience were used as markers of feasibility. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria for both groups included being aged 50 years and older and to have either normal or corrected vision.
Key exclusion criteria (1 listed)
- Exclusion criteria included the presence of any major neurocognitive disorder or the presence of visual deficits that impeded one's ability to complete the 3D task.
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 |
|---|---|---|
| NeurotrackerXAt-home participants loaned the necessary equipment (e.g., 3D-glasses, computer equipment) from the research facilities and engaged in 10 training sessions over five weeks (2x per week). Participant recruitment, retention, adherence and experience were used as markers of feasibility. For program validation, twenty participants above 50 years old, who had previously completed at least eight sessions of the in-lab 3D-MOT program, were randomly selected as the control group. | Device | At home cognitive training |
Primary outcome
Neurotracker scores
Time frame: 5 weeks
Performance on the multiple-object tracking program across 10 sessions. Scores are between 0 - 4, with increasing scores indicating increasing performance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Derived from this study: PubMed 37645472Snowden T, Ohlhauser L, Morrison J, Faubert J, Gawryluk J, Christie BR. A Protocol for Remote Cognitive Training Developed for Use in Clinical Populations During the COVID-19 Pandemic. Neurotrauma Rep. 2023 Aug 14;4(1):522-532. doi: 10.1089/neur.2023.0009. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeurotrackerX in people with Cognition Disorders in Old Age, run by University of Victoria at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Mar 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurotracker scores (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05278273, which also lists 1 linked publication.
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 14 Mar 2022.