Trial from ANZCTR


Trial ID ACTRN12611000702910
Trial Status: Registered
Date Submitted: 29/06/2011
Date Registered: 8/07/2011
Prospectively registered

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Public title Cognitive and neural benefits of brain training.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Double-blind, randomised clinical trial timecourse changes in response to computerised cognitive training compared to active control training in a group of cognitively healthy older adults, as measured with a battery of cognitive tests and MRI scans.
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Secondary ID [1] 262504 0
Nil
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UTN U1111-1122-4704
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Trial acronym
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Health condition(s) or problem(s) studied:
Neuroplasticity in the cognitively healthy elderly 268194 0
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Condition category: Condition code:
Mental Health Studies of normal psychology, cognitive function and behaviour
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Descriptions of intervention(s) / exposure 26 exercises from the COGPACK package, a suite of exercises that are largely based upon well-established neuropsychological tests and principles. Multiple exercises will be used to target the one generic cognitive domain and exercises will include both verbal and visual modalities. Training will be administered in three 1-hour sessions every week for a total period of 12 weeks (i.e. a total of 36 hours), supervised by a member of the research team.
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Intervention Code:
Treatment: Other 266851 0
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Intervention Code:
Prevention 266880 0
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Comparator / control treatment Computerised, intensity matched, general activity didactic viewing and listening exercises, administered in three 1-hour sessions every week for a total period of 12 weeks (i.e. a total of 36 hours) and supervised by a member of the research team.
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Control group Active
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Primary Outcome: Scores in (1)a computer-based adaptation of WAIS 4 Matrix Reasoning test; (2) Controlled Oral Word Association Test (COWAT); (3) the Boston Naming Test (short versions) and (4) a computerised adaptation of the Recognition Memory Test. 269075 0
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Timepoint: At baseline and after (1) 12 weeks of training; (2)12 weeks after the cessation of training; (3) and 12 months after the cessation of training. 269075 0
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Primary Outcome: Scores in (1) A subset of tests taken from Mindstreams: Verbal Memory, Non Verbal Memory, Staged Information Processing Speed, Stroop Interference; (2) "Stockings of Cambridge," a problem solving test from the CANTAB. 269101 0
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Timepoint: All tests in this category will be conducted at baseline and after (1) 3 weeks of training; (2) 12 weeks of training; (3) 3 weeks after the secession of training; (4) 12 weeks after the secession of training; and (5) 12 months after the cessation of training. 269101 0
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Secondary Outcome: (1) Structural plasticity: T1-weighted isometric 3D scan; (2) Biochemical plasticity: Magnetic resonance spectroscopic analysis of metabolites in both the hippocampus and posterior cingulate; (3) Functional plasticity: resting state fMRI scan; and (4) White matter plasticity: Diffusion Tractography Imaging. These outcomes collected on a subsample of n=15 subjects. 276898 0
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Timepoint: At baseline and after (1) 3 weeks of training; and (2) 12 weeks of training 276898 0
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Secondary Outcome: Bayer Instrumental Activities of Daily Living (B-ADL) 300111 0
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Timepoint: Baseline and 12-month after cessation of training. 300111 0
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Key inclusion criteria (1) Non-demented, non-depressed older adults; (2) physical ability to attend brain training sessions 3 times a week
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Minimum age 65 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? Yes
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Key exclusion criteria (1) history, diagnosis or treatment for dementia (of any aetiology); (2) diagnosis or treatment for depression in last 6 months; (3) history of stroke in last 12 months; (4) major neurological disorder requiring current treatment (epilepsy); (5) major psychiatric disorder requiring current treatment (schizophrenia, bipolar disorder); (6) physical (sensory or motor) impairment that would limit ability to engage with training; (7) lack of personal informant who sees the person at least once a week; (8) current undertaking of any other Brain Training program; (9) current alcohol abuse.
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Study type Interventional
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Purpose of the study Educational / counselling / training
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Simple randomisation table created by a computer software
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features 1:1 allocation
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 28/06/2011
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Date of first participant enrolment 12/07/2011
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 80
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 267335 0
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Name: Primary Dementia Collaborative Research Centre 267335 0
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Address: UNSW - Faculty of Medicine, Sydney NSW 2052 267335 0
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Country: Australia 267335 0
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Primary Sponsor Individual
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Name: Dr Michael Valenzuela
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Address: Regenerative Neuroscience Group
Brain and Mind Research Institute
University of Sydney
100 Mallet St
Camperdown NSW 2050
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Country: Australia
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Secondary Sponsor: Individual 266401 0
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Name: A/Prof Sharon Naismith 266401 0
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Address: Physiology, School of Medical Sciences
Brain & Mind Research Institute
M02 - Mallet Street Campus
The University of Sydney
Sydney NSW 2006
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Country: Australia 266401 0
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Other Collaborator: Charities/Societies/Foundations 252082 0
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Name: Sir Moses Montefiore Home 252082 0
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Address: 36 Dangar Street
RANDWICK NSW 2031
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Country: Australia 252082 0
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Other Collaborator: University 252083 0
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Name: The University of Sydney, Brain and Mind Research Institute 252083 0
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Address: 100 Mallett Street
Camperdown NSW 2050
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Country: Australia 252083 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of New South Wales Human Research Ethics Committee 269318 0
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Address: UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
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Country: Australia 269318 0
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Approval Date: 06/05/2011 269318 0
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Submitted Date: 269318 0
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HREC: 11136 269318 0
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Brief summary Research suggests Brain Training may be effective for improving the brain’s ability to store and process information, and imaging studies suggest Brain Training may also lead to positive changes to brain structure and function .
However, most of the research to date has simply measured effects by comparing data before and after a period of Brain Training. The effects of Brain Training during the training period has yet to be properly examined. We would therefore like to answer three main questions:
1. What is the minimum duration of Brain Training required to produce cognitive benefits?
2. By what rate do any positive cognitive effects decay after the cessation of Brain Training?
3. How do different brain changes (as revealed by brain imaging) develop over time?
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Name: Michael Valenzuela
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Address: Regenerative Neuroscience Group Brain and Mind Research Institute University of Sydney 100 Mallet St Camperdown NSW 2050
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Country: Australia
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Tel: +61 2 9114 4135
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Fax: +61 2 9351 0551
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Email: michael.valenzuela@sydney.edu.au
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Contact person for public queries
Title: Mr
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Name: Mr Amit Lampit
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Address: Regenerative Neuroscience Group Brain and Mind Research Institute University of Sydney 100 Mallet St Camperdown NSW 2050
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Country: Australia
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Tel: +61 9114 4134
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Fax: +61 2 9351 0930
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Email: amit.lampit@sydney.edu.au
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Contact person for scientific queries
Title: A/Prof
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Name: Dr Michael Valenzuela
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Address: Regenerative Neuroscience Group Brain and Mind Research Institute University of Sydney 100 Mallet St Camperdown NSW 2050
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Country: Australia
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Tel: +61 2 9114 4135
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Fax: +61 2 9351 0930
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Email: michael.valenzuela@sydney.edu.au
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Contact person responsible for updating information
Title: Mr
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Name: Amit Lampit
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Address: Brain and Mind Research Institute University of Sydney 100 Mallet St CAMPERDOWN NSW 2050
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Country: Australia
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Tel: +61 9114 4134
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Email: amit.lampit@sydney.edu.au
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Addition Cancer fields
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