Age-Related Memory DisordersNCT03763344
An Examination of Visual Perceptual Training
A study testing Perceptual Cognitive Training (PCT) in people with Age-Related Memory Disorders, run by University of Victoria at 1 site in Canada.
Trial summary
Perceptual-cognitive training (PCT) is a computerized software game has been shown to improve sport performance in young elite athletes and even to aid in recovery speeds post-concussion. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Memory Disorders
- What is being tested?
- Perceptual Cognitive Training (PCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jun 2017to 15 Jul 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 and over;
- Have subjective cognitive complaints;
- The results of the screening test Mini Mental State Examination (MMSE) should be ≥ 24 (this test is used only at baseline visit to verify if the participant might be included in the sample or not).
Who cannot join
- Presence of medical diagnosis of a Major Neurocognitive Disorder (e.g. Alzheimer's disease, front temporal lobe dementia, Lewy Body dementia, vascular dementia),
- Presence of sensory deficits (e.g. colour blindness, monocular/binocular blindness, macular degeneration),
- Presence of psychiatric disorders (i.e. depression, anxiety),
- The participants with scores under 24 at MMSE screening test will be excluded and sent to the family doctor (i.e. to minimize the risk of including people with pre-clinical dementia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Examination of Visual Perceptual Training in Older Adults With Subjective Memory Complaints
Perceptual-cognitive training (PCT) is a computerized software game has been shown to improve sport performance in young elite athletes and even to aid in recovery speeds post-concussion. PCT may represent a unique type of training that could ultimately enhance cognitive performance or quality of life in all populations. What is not clear is whether PCT is beneficial to older adults with subjective memory complaints (SMCs). SMCs in older adults are an early risk indicator for Alzheimer's disease, making older adults with SMCs a target population for proactive interventions. The aim of this study was to determine if PCT can serve as a proactive intervention and enhance cognitive abilities in older adults with SMCs. The results of this research protocol introduce a new way of prevention from cognitive decline in healthy older adults and may introduce a new training programs for age-related memory disorder.
Read the detailed description
This study was approved by the University of Victoria Human Research Ethics Board (Protocol Number 17-167) and all participants provided their informed written consent prior to participating in this study. In order to reduce the placebo effect, the participants were randomly divided into the experimental and control groups. Participants from both the experimental and control groups received a total of three neuropsychological assessments over a three month period (i.e. baseline, 7 weeks, 11 weeks). Considering that an essential methodological component of the training studies is the use of standardized neuropsychological tests, validated and reliable measures such as STROOP TEST, DIGIT SPAN TEST, TRAIL MAKING TEST, VERBAL FLUENCY TESTS, CALIFORNIA VERBAL LEARNING TEST Second Edition (i.e., standard and alternate forms), were used at different time points. Each assessment was 50-60 minutes in duration and was administered by an expert neuropsychology resident. The first assessment was administered at baseline . Then, the experimental group underwent seven weeks of perceptual cognitive training, while the control group completed seven weeks without formal training. The treatment for the PCT group consisted of 14 sessions of training each lasting 25-30 min, twice per week for seven weeks. After the seven-week time period, a second neuropsychological assessment was performed on both groups. After eleven weeks, a follow-up assessment was conducted to verify whether the benefits of cognitive training endure over time.
- Conditions
- Age-Related Memory Disorders
- Being tested
- Perceptual Cognitive Training (PCT)
- Keywords
- memory, visual spatial training, multiple object tracking, Elderly
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptual Cognitive Training (PCT)Behavioural
Perceptual Cognitive Training (PCT) will be performed by having individuals work with a visual perceptual training software program called NeuroTracker. This device uses Multiple Object Tracking at increasing difficulties to develop high-level brain functions critical to recovery \& cognitive health. By increasing in difficulty with each correct response and decreasing in difficulty when mistakes are made, brain function is constantly challenged. Each session (6 mins) delivers a series of mini-tests where the patient needs to remember key targets, then track them moving among distractors for several seconds and then identify them. Simple to do, but always challenging, NeuroTracker adaptively optimizes difficulty to each patient's level, maximizing cognitive stimulation every step of the way.
| Study group | Role | What they receive |
|---|---|---|
| Cohort C | Experimental | Older adults over the age of 60 years old with subjective memory complaints that underwent:
* the first cognitive assessment (Baseline),
* intervention is fourteen sessions of Perceptual Cognitive Training (PCT) for seven weeks,
* a post-treatment cognitive assessment (Week 7), and
* a follow up cognitive assessment (Week 11) Receives: Behavioral: Perceptual Cognitive Training (PCT) |
| Cohort D | No intervention | Older adults over the age of 60 years old with subjective memory complaints that underwent: * the first cognitive assessment (baseline), * seven weeks of no intervention, * a post-treatment cognitive assessment (week 7), and * a follow up cognitive assessment (week 11) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in memory performance in older adults with SMCs
Assessed by CALIFORNIA VERBAL LEARNING TEST
Measured: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
Secondary outcomes (4)
Change in processing speed in older adults with SMCs
Assessed by Delis-Kaplan Executive Function System™ (D-KEFS™).
Measured: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
Change in cognitive flexibility in older adults with SMCs
Assessed by Delis-Kaplan Executive Function System™ (D-KEFS™)
Measured: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
Change in cognitive flexibility in older adults with SMCs
Assessed by Stroop Test
Measured: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
Change in working memory in in older adults with SMCs
Assessed by Digit Span Test
Measured: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start28 Jun 2017
- Primary completion30 Jun 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Age-Related Memory DisordersStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 73 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
- Investigators
- Brian R. Christie, Ph.D, Principal investigator, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763344
- Sponsor's protocol ID
- 19-123
- Status last verified
- Sep 2021
- First submitted
- 22 Oct 2018
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berry AS, Zanto TP, Clapp WC, Hardy JL, Delahunt PB, Mahncke HW, Gazzaley A. The influence of perceptual training on working memory in older adults. PLoS One. 2010 Jul 14;5(7):e11537. doi: 10.1371/journal.pone.0011537.
PubMed 20644719Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.
PubMed 24005416Cavanagh P, Alvarez GA. Tracking multiple targets with multifocal attention. Trends Cogn Sci. 2005 Jul;9(7):349-54. doi: 10.1016/j.tics.2005.05.009.
PubMed 15953754Parsons B, Magill T, Boucher A, Zhang M, Zogbo K, Berube S, Scheffer O, Beauregard M, Faubert J. Enhancing Cognitive Function Using Perceptual-Cognitive Training. Clin EEG Neurosci. 2016 Jan;47(1):37-47. doi: 10.1177/1550059414563746. Epub 2014 Dec 30.
PubMed 25550444Tullo D, Guy J, Faubert J, Bertone A. Training with a three-dimensional multiple object-tracking (3D-MOT) paradigm improves attention in students with a neurodevelopmental condition: a randomized controlled trial. Dev Sci. 2018 Nov;21(6):e12670. doi: 10.1111/desc.12670. Epub 2018 Apr 30.
PubMed 29707864Faubert J. Visual perception and aging. Can J Exp Psychol. 2002 Sep;56(3):164-76. doi: 10.1037/h0087394.
PubMed 12271747
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of Visual Perceptual Training in Older Adults With Subjective Memory Complaints
- ClinicalTrials.gov ID
- NCT03763344
- Acronym / sponsor ID
- 19-123
- Conditions
- Age-Related Memory Disorders
- Keywords
- memory, visual spatial training, multiple object tracking, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 4 Dec 2018 (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.
Perceptual-cognitive training (PCT) is a computerized software game has been shown to improve sport performance in young elite athletes and even to aid in recovery speeds post-concussion. PCT may represent a unique type of training that could ultimately enhance cognitive performance or quality of life in all populations. What is not clear is whether PCT is beneficial to older adults with subjective memory complaints (SMCs). SMCs in older adults are an early risk indicator for Alzheimer's disease, making older adults with SMCs a target population for proactive interventions. The aim of this study was to determine if PCT can serve as a proactive intervention and enhance cognitive abilities in older adults with SMCs. The results of this research protocol introduce a new way of prevention from cognitive decline in healthy older adults and may introduce a new training programs for age-related memory disorder.
Detailed description
This study was approved by the University of Victoria Human Research Ethics Board (Protocol Number 17-167) and all participants provided their informed written consent prior to participating in this study. In order to reduce the placebo effect, the participants were randomly divided into the experimental and control groups. Participants from both the experimental and control groups received a total of three neuropsychological assessments over a three month period (i.e. baseline, 7 weeks, 11 weeks). Considering that an essential methodological component of the training studies is the use of standardized neuropsychological tests, validated and reliable measures such as STROOP TEST, DIGIT SPAN TEST, TRAIL MAKING TEST, VERBAL FLUENCY TESTS, CALIFORNIA VERBAL LEARNING TEST Second Edition (i.e., standard and alternate forms), were used at different time points. Each assessment was 50-60 minutes in duration and was administered by an expert neuropsychology resident. The first assessment was administered at baseline . Then, the experimental group underwent seven weeks of perceptual cognitive training, while the control group completed seven weeks without formal training. The treatment for the PCT group consisted of 14 sessions of training each lasting 25-30 min, twice per week for seven weeks. After the seven-week time period, a second neuropsychological assessment was performed on both groups. After eleven weeks, a follow-up assessment was conducted to verify whether the benefits of cognitive training endure over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort C | Experimental | Behavioral: Perceptual Cognitive Training (PCT)Older adults over the age of 60 years old with subjective memory complaints that underwent: * the first cognitive assessment (Baseline), * intervention is fourteen sessions of Perceptual Cognitive Training (PCT) for seven weeks, * a post-treatment cognitive assessment (Week 7), and * a follow up cognitive assessment (Week 11) |
| Cohort D | No intervention | –Older adults over the age of 60 years old with subjective memory complaints that underwent: * the first cognitive assessment (baseline), * seven weeks of no intervention, * a post-treatment cognitive assessment (week 7), and * a follow up cognitive assessment (week 11) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60 and over;
- Have subjective cognitive complaints;
- The results of the screening test Mini Mental State Examination (MMSE) should be ≥ 24 (this test is used only at baseline visit to verify if the participant might be included in the sample or not).
Key exclusion criteria (4 listed)
- Presence of medical diagnosis of a Major Neurocognitive Disorder (e.g. Alzheimer's disease, front temporal lobe dementia, Lewy Body dementia, vascular dementia),
- Presence of sensory deficits (e.g. colour blindness, monocular/binocular blindness, macular degeneration),
- Presence of psychiatric disorders (i.e. depression, anxiety),
- The participants with scores under 24 at MMSE screening test will be excluded and sent to the family doctor (i.e. to minimize the risk of including people with pre-clinical dementia).
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 |
|---|---|---|
| Perceptual Cognitive Training (PCT)Perceptual Cognitive Training (PCT) will be performed by having individuals work with a visual perceptual training software program called NeuroTracker. This device uses Multiple Object Tracking at increasing difficulties to develop high-level brain functions critical to recovery \& cognitive health. By increasing in difficulty with each correct response and decreasing in difficulty when mistakes are made, brain function is constantly challenged. Each session (6 mins) delivers a series of mini-tests where the patient needs to remember key targets, then track them moving among distractors for several seconds and then identify them. Simple to do, but always challenging, NeuroTracker adaptively optimizes difficulty to each patient's level, maximizing cognitive stimulation every step of the way. | Behavioural | Cohort C |
Primary outcome
Change in memory performance in older adults with SMCs
Time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
Assessed by CALIFORNIA VERBAL LEARNING TEST
4 secondary outcomes
Change in processing speed in older adults with SMCs
Time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
Change in cognitive flexibility in older adults with SMCs
Time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
Change in cognitive flexibility in older adults with SMCs
Time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
Change in working memory in in older adults with SMCs
Time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
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 5 Oct 2021.
- Background: PubMed 20644719Berry AS, Zanto TP, Clapp WC, Hardy JL, Delahunt PB, Mahncke HW, Gazzaley A. The influence of perceptual training on working memory in older adults. PLoS One. 2010 Jul 14;5(7):e11537. doi: 10.1371/journal.pone.0011537.
- Background: PubMed 24005416Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.
- Background: PubMed 15953754Cavanagh P, Alvarez GA. Tracking multiple targets with multifocal attention. Trends Cogn Sci. 2005 Jul;9(7):349-54. doi: 10.1016/j.tics.2005.05.009.
- Background: PubMed 25550444Parsons B, Magill T, Boucher A, Zhang M, Zogbo K, Berube S, Scheffer O, Beauregard M, Faubert J. Enhancing Cognitive Function Using Perceptual-Cognitive Training. Clin EEG Neurosci. 2016 Jan;47(1):37-47. doi: 10.1177/1550059414563746. Epub 2014 Dec 30.
- Background: PubMed 29707864Tullo D, Guy J, Faubert J, Bertone A. Training with a three-dimensional multiple object-tracking (3D-MOT) paradigm improves attention in students with a neurodevelopmental condition: a randomized controlled trial. Dev Sci. 2018 Nov;21(6):e12670. doi: 10.1111/desc.12670. Epub 2018 Apr 30.
- Background: PubMed 12271747Faubert J. Visual perception and aging. Can J Exp Psychol. 2002 Sep;56(3):164-76. doi: 10.1037/h0087394.
- 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.
Brian R. Christie, Ph.D principal investigator
University of Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceptual Cognitive Training (PCT) in people with Age-Related Memory Disorders, 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 3 inclusion and 4 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 5 Oct 2021. 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?
Change in memory performance in older adults with SMCs (time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).). 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 NCT03763344, which also lists 6 linked publications.
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 5 Oct 2021.