An Examination of Visual Perceptual Training

September 27, 2021 updated by: Brian Christie, University of Victoria

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8P5C2
        • University of Victoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort C

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)
Behavioral: 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.
No Intervention: Cohort D

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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Assessed by Delis-Kaplan Executive Function System™ (D-KEFS™).
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).
Assessed by Delis-Kaplan Executive Function System™ (D-KEFS™)
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).
Assessed by Stroop Test
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).
Assessed by Digit Span Test
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Victoria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian R. Christie, Ph.D, University of Victoria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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