ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000702910

Ethics application status

Approved

Date submitted

29/06/2011

Date registered

8/07/2011

Date last updated

9/07/2018

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]

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

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]

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]

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]

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]

(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]

At baseline and after (1) 3 weeks of training; and (2) 12 weeks of training

Secondary outcome [2]

Bayer Instrumental Activities of Daily Living (B-ADL)

Timepoint [2]

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

Sex

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

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

28/06/2011

Actual

12/07/2011

Date of last participant enrolment

Anticipated

Actual

10/04/2012

Date of last data collection

Anticipated

Actual

5/07/2013

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Primary Dementia Collaborative Research Centre

Address [1]

UNSW - Faculty of Medicine, Sydney NSW 2052

Country [1]

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]

Individual

Name [1]

A/Prof Sharon Naismith

Address [1]

Physiology, School of Medical Sciences
Brain & Mind Research Institute
M02 - Mallet Street Campus
The University of Sydney
Sydney NSW 2006

Country [1]

Australia

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Sir Moses Montefiore Home

Address [1]

36 Dangar Street
RANDWICK NSW 2031

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

The University of Sydney, Brain and Mind Research Institute

Address [2]

100 Mallett Street
Camperdown NSW 2050

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Human Research Ethics Committee

Ethics committee address [1]

UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales 
SYDNEY NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/05/2011

Ethics approval number [1]

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

A/Prof Michael Valenzuela

Address

Regenerative Neuroscience Group
Brain and Mind Research Institute
University of Sydney
100 Mallet St Camperdown
NSW 2050

Country

Australia

Phone

+61 2 9114 4135

Fax

+61 2 9351 0551

michael.valenzuela@sydney.edu.au

Contact person for public queries

Name

Mr Amit Lampit

Address

Regenerative Neuroscience Group
Brain and Mind Research Institute
University of Sydney
100 Mallet St
Camperdown NSW 2050

Country

Australia

Phone

+61 9114 4134

Fax

+61 2 9351 0930

amit.lampit@sydney.edu.au

Contact person for scientific queries

Name

Dr Michael Valenzuela

Address

Regenerative Neuroscience Group
Brain and Mind Research Institute
University of Sydney
100 Mallet St
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9114 4135

Fax

+61 2 9351 0930

michael.valenzuela@sydney.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Cognitive training-induced short-term functional and long-term structural plastic change is related to gains in global cognition in healthy older adults: A pilot study.	2015	https://dx.doi.org/10.3389/fnagi.2015.00014

N.B. These documents automatically identified may not have been verified by the study sponsor.

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