Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000251527
Ethics application status
Approved
Date submitted
2/03/2015
Date registered
19/03/2015
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Neurocognitive training for traumatic brain injury: cognitive, behavioural, and electrophysiological outcomes.
Scientific title
Does neurocognitive training improve cognitive, behavioural, and electrophysiological outcomes in adults with TBI compared to a waitlist control group?
Secondary ID [1] 286104 0
Nil known
Universal Trial Number (UTN)
U1111-1166-9172
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 294105 0
Condition category
Condition code
Injuries and Accidents 294418 294418 0 0
Other injuries and accidents
Neurological 294751 294751 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Focus Pocus (version 2) neurocognitive training software was developed by NeuroCog Proprietary Limited incorporating intellectual property licensed from UOW. The software consists of a series of wizard-themed, computerised, mini-games targeting inhibitory control (IC), working memory (WM) and state control (SC). During use of the software, participants are required to wear a portable EEG headset; the NeuroSky MindWave. The headset records EEG from a single, dry, sensor resting on the forehead referenced to an ear-clip electrode.

During SC games, participants are instructed to ‘focus’, ‘relax’ or induce a state of ‘zen' (i.e. focused and relaxed), and the corresponding EEG pattern is used to control elements of the game (e.g. the speed of the player in a broomstick race). During WM and IC games, EEG is passively monitored and categorised according to attention level during the game, with attention level then used as a multiplier for game points. Game difficulty adapts constantly based on performance to ensure that games are challenging but not too difficult. Participants receive on-screen feedback about performance following each game.

In the present study, participants will be required to complete 25 sessions of the neurocognitive training, at a rate of 5 sessions per week. Each training session will consist of 6 SC, 4 WM, and 4 IC games, and will take approximately 20 minutes to complete. Participants will self-administer the training in their own homes, using their own personal computer or iOS device and a loan headset. Data regarding training compliance and performance will be sent to an online server, so that researchers can monitor progress.
Intervention code [1] 291101 0
Rehabilitation
Comparator / control treatment
Participants in a waitlist control condition will be offered the neurocognitive training program after the 6 week follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 294213 0
EEG power in resting and active conditions
Timepoint [1] 294213 0
Baseline and post-training
Primary outcome [2] 294214 0
Scores on the Behaviour Rating Inventory of Executive Function for adults (BRIEF-A)
Timepoint [2] 294214 0
Baseline, post-training, and 6 week follow-up
Primary outcome [3] 294215 0
Scores on the subtest CogState cognitive assessment battery
Timepoint [3] 294215 0
Baseline and post-training
Secondary outcome [1] 312788 0
Performance (accuracy and reaction time) on an auditory Go/Nogo task
Timepoint [1] 312788 0
Baseline and post-training
Secondary outcome [2] 312789 0
Performance (accuracy and reaction time) on an auditory oddball task
Timepoint [2] 312789 0
Baseline and post-training
Secondary outcome [3] 312790 0
Performance on a Stop-signal task
Timepoint [3] 312790 0
Baseline and post-training
Secondary outcome [4] 312791 0
Event-related potentials in an auditory Go/Nogo task
Timepoint [4] 312791 0
Baseline and post-training
Secondary outcome [5] 312792 0
Event-related potentials in an auditory oddball task
Timepoint [5] 312792 0
Baseline and post-training
Secondary outcome [6] 312793 0
Event-related potentials in a stop-signal task
Timepoint [6] 312793 0
Baseline and post-training

Eligibility
Key inclusion criteria
Sustained a TBI at least 6 months ago
Subjective reports of cognitive impairment (attention, memory, executive function)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Drug and alcohol disorders
Psychiatric disorders, dementia or neurodegenerative disease
Vision, hearing, motor or communication problems restricting use of computer software/hardware

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
24/03/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290845 0
University
Name [1] 290845 0
University of Wollongong
Country [1] 290845 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
School of Psychology
University of Wollongong
Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 289540 0
Individual
Name [1] 289540 0
Stuart Johnstone
Address [1] 289540 0
School of Psychology
University of Wollongong
Wollongong NSW 2522
Country [1] 289540 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292317 0
UOW & ISLHD Health and Medical Human Research Ethics Committee
Ethics committee address [1] 292317 0
Ethics Unit, Research Services Office
University of Wollongong NSW 2522
Ethics committee country [1] 292317 0
Australia
Date submitted for ethics approval [1] 292317 0
Approval date [1] 292317 0
09/05/2014
Ethics approval number [1] 292317 0
HE13/110

Summary
Brief summary
The primary purpose of the study is to assess the efficacy of a neurocognitive training program for improving executive function and arousal state modulation in adults with traumatic brain injury. It is expected that compared to a waitlist control, those who complete the training will show improvements on a rang of cognitive and behavioural measures of executive function, as well as improvement in their ability to regulate arousal state of the brain (brain activity measured by EEG).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54554 0
A/Prof Stuart Johnstone
Address 54554 0
School of Psychology
University of Wollongong
Wollongong NSW 2522
Country 54554 0
Australia
Phone 54554 0
+61 2 4221 4495
Fax 54554 0
Email 54554 0
[email protected]
Contact person for public queries
Name 54555 0
Miss Melinda Hickey
Address 54555 0
School of Psychology
University of Wollongong
Wollongong NSW 2522
Country 54555 0
Australia
Phone 54555 0
+61 2 4221 4164
Fax 54555 0
Email 54555 0
[email protected]
Contact person for scientific queries
Name 54556 0
Miss Melinda Hickey
Address 54556 0
School of Psychology
University of Wollongong
Wollongong NSW 2522
Country 54556 0
Australia
Phone 54556 0
+61 2 4221 4164
Fax 54556 0
Email 54556 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.