- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03661190
Online Grammatical Reasoning Training for Older Adults (START)
Impact of Short-term Intensive Online Grammatical Reasoning Training on Cognition and Function in Adults Over 50: An Online Randomised Controlled Trial
The START study will investigate the impact of playing a Grammatical Reasoning brain training task on overall brain function (cognition) and day-to-day function in people over 50.
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Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study builds on existing work that has shown very promising results with brain training approaches in older adults. There is good evidence that playing brain training games leads to improvements in brain functions including memory and reasoning. There is also a suggestion that regular involvement in brain training games might help reduce the risk of cognitive decline and dementia later in life. It appears that reasoning, or problem-solving, is particularly important as it is one of the first abilities to decline with age. This study will use this evidence to target reasoning in a specific brain training task. It will also explore the potential role of genetic factors in how people perform in the task.
The study will compare the impact of a Grammatical Reasoning Task (START) with a control task consisting of simple picture-matching. Over 7000 participants will be randomly allocated to either START or the control and will be asked to play the task as often as they wish for a period of six weeks. Both tasks will be delivered entirely online so people will access the study from home on their computers. This will be achieved through our dedicated online research platform, PROTECT, which hosts a cohort of over 20,000 older adults who have provided DNA samples as part of a longitudinal study.
This study will measure the impact of the training on cognition and Instrumental Activities of Daily Living. Assessments will be completed online at baseline, two/six weeks and six months. Overall, this study aims to generate exciting new data about how brain training could be included in guidance on healthy ageing
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Exeter, United Kingdom, EX1 2LU
- University of Exeter Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults over 50
- Access to a computer with a keyboard and the internet
- Participant registered on the PROTECT study
Exclusion Criteria:
- Diagnosis of dementia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Grammatical Reasoning
This group will complete a short-term Intensive Grammatical Reasoning cognitive task delivered online by Wesnes Cognition Ltd (START).
Participants will be encouraged to complete the START training once a day for six-weeks.
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START measures the ability to determine the relationships among different shape combinations which are assigned to grammatical statements about them which can be either correct or incorrect.
It is a measure of attention, working memory and executive control.
Other Names:
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Other: Control - Card Pairs
The control group will complete a basic picture-matching task that will provide the same level of engagement, but without the learning effects.
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A basic picture-matching task.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Executive Function From Baseline
Time Frame: Baseline to Six weeks
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Measured by the validated task-switching test of Trailmaking B. This is a well established computerised test of executive function. On a computer screen participants are presented with 24 circles with either numbers (0-13) or letters (A-L). They must select the circles in the correct numerical and alphabetic order, alternating numbers and letters each time (e.g. 1, A, 2, B, 3, C etc). The test is completed when all the circles have been correctly selected. The test outputs a total score. A higher score indicates a better performance. A negative mean score indicates a decline in performance. The range of scoring for this test is 0 - 300,000. Data reported here are for mean change per group form baseline to six weeks |
Baseline to Six weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Numerical Working Memory From Six Weeks
Time Frame: Baseline to six weeks
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Digit Span test for numerical working memory.
Partifcipants complete a computerised task.
They must remember increasingly long strings of digits and repeat them back.
Scores are based on correct responses.
Higher score means better performance.
Score range is 0 - 20
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Baseline to six weeks
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Change in Working Memory From Baseline
Time Frame: Baseline to six weeks
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Measured through a computerised version of the Paired Associate Learning task in which participants must remember the location of a symbol behind a series of boxes on a screen, and accurately identify the correct location when prompted.
Scores are based on accuracy.
Higher score indicates better performance.
Data reported here shows mean change from baseline.
Range of scores is 0 - 16
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Baseline to six weeks
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Change in Reaction Time From Baseline
Time Frame: Baseline to six weeks
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Measured through a Simple Reaction time test as part of the Wesnes Cognition Ltd CogTrackTM system.
Participants are shown a target symbol on the screen and must react by pressing the keyboard / touching the screen (depending on the device being used) when the target appears.
Output is measured in milliseconds as a reaction time variable.
Lower scores are better; higher scores are worse.
Range of scores is 100 - 30,000
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Baseline to six weeks
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Change in Episodic Memory From Baseline
Time Frame: Baseline to six weeks
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Measured with the Delayed Picture Recognition task in which participants recall a series of images shown earlier in the cognitive test battery.
The test outputs percentage of correct answers as the measure.
A higher score shows a better outcome.
Range output is 0 - 100
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Baseline to six weeks
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Change in Overall Composite Measure of Global Cognition
Time Frame: Baseline to six weeks
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This is a composite measure of overall cognition that is created by normalising the outputs from all other cognitive tests to give a total score out of 100.
The data shown here is the change in total score from baseline to six weeks.
Range is 0 - 100.
A higher score indicates a better outcome
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Baseline to six weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne Corbett, BSc MRes PhD, University of Exeter Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 216941
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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