Mild Cognitive ImpairmentNCT02559063
Vision-based Speed of Processing Cognitive Training and Mild Cognitive Impairment
A study testing Vision-based speed of processing training and Mental leisure activities in people with Mild Cognitive Impairment, run by University of Rochester at 1 site in United States.
Trial summary
This project seeks to identify neural changes that occur in adults with mild cognitive impairment (MCI) after engagement in computerized cognitive training. In addition, this project aims to identify physiological factors that may bolster effects of the training on cognitive function. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Vision-based speed of processing training and Mental leisure activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2016to 1 Jul 2019
- 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
- a clinical diagnosis of "mild cognitive impairment due to Alzheimer's disease" using the most recent NIA and Alzheimer's Association workshop criteria within 3 months: a) must have memory deficit (1-1.5SD below age- and education-corrected population norms); b) may have deficits in other cognitive domains (e.g., executive function); c) preserved BADL, defined as requiring occasional assistance on less than two items on the Minimum Data Set-Home Care interview, d) absence of dementia using NINCDS-ADRDA criteria;
- if on AD medication (i.e., memantine or cholinesterase inhibitors), no changes of doses in the 3 months prior to recruitment;
- capacity to give consent based on clinician assessment; and
- other: age ≥60 years, English-speaking, adequate visual acuity for testing, and community-dwelling.
Who cannot join
- current enrollment in another cognitive improvement study;
- major depression: 15-item Geriatric Depression Scale scored > 7;
- MRI contraindications, e.g., metallic implant, pacemaker, claustrophobia; and
- major vascular diseases: stroke, myocardial infarction, congestive heart failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Memory Care Program
Rochester, New York, 14642
About this study
Official title: Neurophysiological Aspects of Vision-based Speed of Processing Cognitive Training in Older Adults With Mild Cognitive Impairment
This project seeks to identify neural changes that occur in adults with mild cognitive impairment (MCI) after engagement in computerized cognitive training. In addition, this project aims to identify physiological factors that may bolster effects of the training on cognitive function. Individuals with MCI are at high risk for Alzheimer's disease (AD). Understanding how cognitive training protects cognitive function in MCI can contribute to development of effective interventions to slow progression to AD in individuals at risk, thereby reducing the significant morbidity and health care costs associated with AD.
Read the detailed description
Mild Cognitive Impairment (MCI), especially amnestic type, is considered a symptomatic pre-Alzheimer's disease (AD) phase, and is prevalent in the aging population. Vision-based speed of processing (VSOP) cognitive training is one of the most widely applied behavioral interventions in community-dwelling older Americans free of AD, holding potential to slow cognitive decline. Its particular relevance to MCI is supported by converging evidence from our preliminary studies, including a recently completed pilot intervention study. However, we know little about the mechanisms underlying the benefits of VSOP training, limiting our ability to further exploit VSOP or other forms of cognitive training. In particular, we do not know if and how the effects of VSOP training on cognitive performance are mediated by neuroplasticity-related brain changes. Since recent evidence suggests that neuroplasticity is inducible throughout adult life, even in MCI, it is possible that VSOP training promotes neuroplasticity and slows neurodegeneration. In this early stage and new investigator application, we will focus on assessing whether and how VSOP training, relative to mental leisure activities (MLA), alters cognitive and neural functions in older adults with MCI, up to 6 months after training. The study will enroll and randomize 84 participants with amnestic MCI to VSOP training or MLA control groups. Three specific research aims are to (1) determine whether VSOP training improves processing speed and attention that are associated with changes of brain structural and functional connectivity; (2) test a novel neurophysiological pathway of VSOP training effect on brain structure and function; (3) examine the effect of VSOP training on untrained cognitive and functional domains and the role of neurophysiological changes underlying possible transfer effects. By examining multiple neural and novel physiological mechanisms linking a promising VSOP training intervention to improvements in cognitive performance, this application seeks to challenge and shift current research on cognitive training that merely examines training effects on cognitive outcomes. Discovery of neural, and physiological-related mechanisms in VSOP training will have important implications beyond this particular intervention. Findings from recent behavioral studies (e.g., cognitive intervention, physical exercise, nutrition, and bio-feedback intervention) suggest that for cognitive decline to be mitigated in individuals at risk for AD, it will be necessary for interventions to target the neural and peripheral physiological pathways that are susceptible to AD neuropathology. Confirmation of the study hypotheses could support immediate translation to clinical practices by demonstrating the efficacy, sustainability, and generalizability of cognitive training.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Vision-based speed of processing training, Mental leisure activities
- Keywords
- cognitive training, speed of processing, neuroplasticity, cognitive aging
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision-based speed of processing trainingBehavioural
computerized cognitive tasks addressing vision-based speed of processing
Mental leisure activitiesBehavioural
computerized cognitive tasks addressing different aspects of executive function
| Study group | Role | What they receive |
|---|---|---|
| Vision-based speed of processing | Experimental | Vision-based speed of processing training will use the INSIGHT online program (Posit Science), which includes five games (i.e., Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All games share visual components, and the tasks become increasingly more difficult and require faster reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores. Receives: Behavioral: Vision-based speed of processing training |
| Mental leisure activities | Active comparator | Mental leisure activities control activities were chosen to: 1) control for computer, online experience [and amount of time]; 2) not induce acute stress (i.e., without time management, speed component, or novel cognitive stimuli); 3) simulate participants' everyday mental activities; and 4) entertain participants to keep them from dropping out. Cross-word, Sudoku, and solitaire games will be used, which were also used in previous VSOP training study as control exercises. Participants can choose to practice any combination of games. At the end of their participation, the MLA control group will be provided with free 6-week access to the VSOP training program. Receives: Behavioral: Mental leisure activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention and processing speed test (UFOV)
Measured: change from baseline to 6-month follow-up
Secondary outcomes (4)
Cognitive control and working memory (EXAMINER)
Measured: change from baseline to 6-month follow-up
instrumental activities of daily living (TIADL)
Measured: change from baseline to 6-month follow-up
mean of functional connectivity in default mode network
Resting state fMRI will be used to assess the functional connectivity of the neural network. SPM will be used to analyze and determine the change of the connectivity over time.
Measured: change from baseline to 6-month follow-up
mean of structural connectivity in default mode network
Diffusion tensor imaging will be used to assess the structural connectivity of the neural network. FSL will be used to analyze and determine the change of the connectivity over time.
Measured: change from baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start12 Jan 2016
- Primary completion9 Oct 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Vankee Lin, University of Rochester
- Investigators
- Vankee Lin, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559063
- Sponsor's protocol ID
- 1R01NR015452
- Other IDs
- 1R01NR015452
- Status last verified
- Oct 2019
- First submitted
- 22 Sep 2015
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Aspects of Vision-based Speed of Processing Cognitive Training in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02559063
- Acronym / sponsor ID
- 1R01NR015452
- Conditions
- Mild Cognitive Impairment
- Keywords
- cognitive training, speed of processing, neuroplasticity, cognitive aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 24 Sep 2015 (estimated)
- 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.
This project seeks to identify neural changes that occur in adults with mild cognitive impairment (MCI) after engagement in computerized cognitive training. In addition, this project aims to identify physiological factors that may bolster effects of the training on cognitive function. Individuals with MCI are at high risk for Alzheimer's disease (AD). Understanding how cognitive training protects cognitive function in MCI can contribute to development of effective interventions to slow progression to AD in individuals at risk, thereby reducing the significant morbidity and health care costs associated with AD.
Detailed description
Mild Cognitive Impairment (MCI), especially amnestic type, is considered a symptomatic pre-Alzheimer's disease (AD) phase, and is prevalent in the aging population. Vision-based speed of processing (VSOP) cognitive training is one of the most widely applied behavioral interventions in community-dwelling older Americans free of AD, holding potential to slow cognitive decline. Its particular relevance to MCI is supported by converging evidence from our preliminary studies, including a recently completed pilot intervention study. However, we know little about the mechanisms underlying the benefits of VSOP training, limiting our ability to further exploit VSOP or other forms of cognitive training. In particular, we do not know if and how the effects of VSOP training on cognitive performance are mediated by neuroplasticity-related brain changes. Since recent evidence suggests that neuroplasticity is inducible throughout adult life, even in MCI, it is possible that VSOP training promotes neuroplasticity and slows neurodegeneration. In this early stage and new investigator application, we will focus on assessing whether and how VSOP training, relative to mental leisure activities (MLA), alters cognitive and neural functions in older adults with MCI, up to 6 months after training. The study will enroll and randomize 84 participants with amnestic MCI to VSOP training or MLA control groups. Three specific research aims are to (1) determine whether VSOP training improves processing speed and attention that are associated with changes of brain structural and functional connectivity; (2) test a novel neurophysiological pathway of VSOP training effect on brain structure and function; (3) examine the effect of VSOP training on untrained cognitive and functional domains and the role of neurophysiological changes underlying possible transfer effects. By examining multiple neural and novel physiological mechanisms linking a promising VSOP training intervention to improvements in cognitive performance, this application seeks to challenge and shift current research on cognitive training that merely examines training effects on cognitive outcomes. Discovery of neural, and physiological-related mechanisms in VSOP training will have important implications beyond this particular intervention. Findings from recent behavioral studies (e.g., cognitive intervention, physical exercise, nutrition, and bio-feedback intervention) suggest that for cognitive decline to be mitigated in individuals at risk for AD, it will be necessary for interventions to target the neural and peripheral physiological pathways that are susceptible to AD neuropathology. Confirmation of the study hypotheses could support immediate translation to clinical practices by demonstrating the efficacy, sustainability, and generalizability of cognitive training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vision-based speed of processing | Experimental | Behavioral: Vision-based speed of processing trainingVision-based speed of processing training will use the INSIGHT online program (Posit Science), which includes five games (i.e., Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All games share visual components, and the tasks become increasingly more difficult and require faster reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores. |
| Mental leisure activities | Active comparator | Behavioral: Mental leisure activitiesMental leisure activities control activities were chosen to: 1) control for computer, online experience [and amount of time]; 2) not induce acute stress (i.e., without time management, speed component, or novel cognitive stimuli); 3) simulate participants' everyday mental activities; and 4) entertain participants to keep them from dropping out. Cross-word, Sudoku, and solitaire games will be used, which were also used in previous VSOP training study as control exercises. Participants can choose to practice any combination of games. At the end of their participation, the MLA control group will be provided with free 6-week access to the VSOP training program. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a clinical diagnosis of "mild cognitive impairment due to Alzheimer's disease" using the most recent NIA and Alzheimer's Association workshop criteria within 3 months: a) must have memory deficit (1-1.5SD below age- and education-corrected population norms); b) may have deficits in other cognitive domains (e.g., executive function); c) preserved BADL, defined as requiring occasional assistance on less than two items on the Minimum Data Set-Home Care interview, d) absence of dementia using NINCDS-ADRDA criteria;
- if on AD medication (i.e., memantine or cholinesterase inhibitors), no changes of doses in the 3 months prior to recruitment;
- capacity to give consent based on clinician assessment; and
- other: age ≥60 years, English-speaking, adequate visual acuity for testing, and community-dwelling.
Key exclusion criteria (4 listed)
- current enrollment in another cognitive improvement study;
- major depression: 15-item Geriatric Depression Scale scored > 7;
- MRI contraindications, e.g., metallic implant, pacemaker, claustrophobia; and
- major vascular diseases: stroke, myocardial infarction, congestive heart failure.
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 |
|---|---|---|
| Vision-based speed of processing trainingcomputerized cognitive tasks addressing vision-based speed of processing | Behavioural | Vision-based speed of processing |
| Mental leisure activitiescomputerized cognitive tasks addressing different aspects of executive function | Behavioural | Mental leisure activities |
Primary outcome
Attention and processing speed test (UFOV)
Time frame: change from baseline to 6-month follow-up
4 secondary outcomes
Cognitive control and working memory (EXAMINER)
Time frame: change from baseline to 6-month follow-up
instrumental activities of daily living (TIADL)
Time frame: change from baseline to 6-month follow-up
mean of functional connectivity in default mode network
Time frame: change from baseline to 6-month follow-up
mean of structural connectivity in default mode network
Time frame: change from baseline to 6-month follow-up
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 2 Oct 2019.
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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.
Vankee Lin, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vision-based speed of processing training and Mental leisure activities in people with Mild Cognitive Impairment, run by University of Rochester at 1 site in United States.
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 4 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 2 Oct 2019. 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 United States. 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?
Attention and processing speed test (UFOV) (time frame: change from baseline to 6-month follow-up). 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 2 Oct 2019.