Trial registered on ANZCTR


Trial ID
ACTRN12611000702910
Ethics application status
Approved
Date submitted
29/06/2011
Date registered
8/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive and neural benefits of brain training.
Scientific title
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.
Secondary ID [1] 262504 0
Nil
Universal Trial Number (UTN)
U1111-1122-4704
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroplasticity in the cognitively healthy elderly 268194 0
Condition category
Condition code
Mental Health 268320 268320 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 266851 0
Treatment: Other
Intervention code [2] 266880 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 269075 0
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.
Timepoint [1] 269075 0
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.
Primary outcome [2] 269101 0
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.
Timepoint [2] 269101 0
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.
Secondary outcome [1] 276898 0
(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.
Timepoint [1] 276898 0
At baseline and after (1) 3 weeks of training; and (2) 12 weeks of training
Secondary outcome [2] 300111 0
Bayer Instrumental Activities of Daily Living (B-ADL)
Timepoint [2] 300111 0
Baseline and 12-month after cessation of training.

Eligibility
Key inclusion criteria
(1) Non-demented, non-depressed older adults; (2) physical ability to attend brain training sessions 3 times a week
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
1:1 allocation
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
28/06/2011
Actual date of first participant enrolment
12/07/2011
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
80
Actual sample size
Recruitment status
Active, not recruiting
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267335 0
Government body
Name [1] 267335 0
Primary Dementia Collaborative Research Centre
Address [1] 267335 0
UNSW - Faculty of Medicine, Sydney NSW 2052
Country [1] 267335 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Valenzuela
Address
Regenerative Neuroscience Group
Brain and Mind Research Institute
University of Sydney
100 Mallet St
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 266401 0
Individual
Name [1] 266401 0
A/Prof Sharon Naismith
Address [1] 266401 0
Physiology, School of Medical Sciences
Brain & Mind Research Institute
M02 - Mallet Street Campus
The University of Sydney
Sydney NSW 2006
Country [1] 266401 0
Australia
Other collaborator category [1] 252082 0
Charities/Societies/Foundations
Name [1] 252082 0
Sir Moses Montefiore Home
Address [1] 252082 0
36 Dangar Street
RANDWICK NSW 2031
Country [1] 252082 0
Australia
Other collaborator category [2] 252083 0
University
Name [2] 252083 0
The University of Sydney, Brain and Mind Research Institute
Address [2] 252083 0
100 Mallett Street
Camperdown NSW 2050
Country [2] 252083 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269318 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 269318 0
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 269318 0
Australia
Date submitted for ethics approval [1] 269318 0
Approval date [1] 269318 0
06/05/2011
Ethics approval number [1] 269318 0
11136

Summary
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?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32804 0
A/Prof Michael Valenzuela
Address 32804 0
Regenerative Neuroscience Group
Brain and Mind Research Institute
University of Sydney
100 Mallet St Camperdown
NSW 2050
Country 32804 0
Australia
Phone 32804 0
+61 2 9114 4135
Fax 32804 0
+61 2 9351 0551
Email 32804 0
michael.valenzuela@sydney.edu.au
Contact person for public queries
Name 16051 0
Mr Mr Amit Lampit
Address 16051 0
Regenerative Neuroscience Group
Brain and Mind Research Institute
University of Sydney
100 Mallet St
Camperdown NSW 2050
Country 16051 0
Australia
Phone 16051 0
+61 9114 4134
Fax 16051 0
+61 2 9351 0930
Email 16051 0
amit.lampit@sydney.edu.au
Contact person for scientific queries
Name 6979 0
A/Prof Dr Michael Valenzuela
Address 6979 0
Regenerative Neuroscience Group
Brain and Mind Research Institute
University of Sydney
100 Mallet St
Camperdown NSW 2050
Country 6979 0
Australia
Phone 6979 0
+61 2 9114 4135
Fax 6979 0
+61 2 9351 0930
Email 6979 0
michael.valenzuela@sydney.edu.au