Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000578505
Ethics application status
Approved
Date submitted
20/05/2015
Date registered
3/06/2015
Date last updated
6/05/2021
Date data sharing statement initially provided
6/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Combining Transcranial Direct Current Stimulation (tDCS) with Cognitive Training for Cognitive Impairment following Traumatic Brain Injury: A Pilot Study
Scientific title
Investigating the neurobiological and neurocognitive effects of combining cognitive training with tDCS following traumatic brain injury.
Secondary ID [1] 286761 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury (TBI) 295134 0
Condition category
Condition code
Injuries and Accidents 295379 295379 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo repeated sessions (20 in total) of Transcranial Direct Current Stimulation (tDCS). tDCS involves the application of a very gentle electrical current applied using two surface electrodes (anode and cathode) to the scalp . tDCS has been shown to increase brain activity in areas important for cognition.

Participants will be randomly allocated to one of the following two conditions;
1. Twenty sessions of 20 minute active tDCS to the left Dorsolateral Prefrontal Cortex (DLPFC) at a current density of 0.0057 ma/cm over four weeks, Monday-Friday combined with computerised cognitive training using 'Brain HQ' a commercially available cognitive training package from Posit Science.

2. Twenty sessions of 20 minute sham tDCS to the left DLPFC at a current density of 0.0057 ma/cm over four weeks, Monday-Friday combined with computerised cognitive training using 'Brain HQ' a commercially available cognitive training package from Posit Science.

The computerised cognitive training will be completed on a laptop computer for 5 x 30 minute sessions per week for 4 weeks. Cognitive training will be completed in the presence of a research assistant who will monitor engagement/adherence with the training. The computerised tasks are designed to target attention, processing speed and memory.
Intervention code [1] 291920 0
Treatment: Devices
Comparator / control treatment
Stimulation will be delivered using the StarStim system which allows for
programming of tDCS, itDCS and sham.
Sham tDCS is achieved by switching off stimulation after approx. 30s;
which occurs within the software of the Starstim system allowing for
administrator and patient blinding. There is no evidence that 30 seconds
of tDCS induces any changes in the brain. The provision of stimulation for
30 seconds allows participants to experience the initial physical
sensations of tDCS, which typically fade after 30seconds, thus providing
a robust sham. This is a standard method of blinding for tDCS.

The computerised cognitive training will be completed on a laptop computer for 5 x 30 minute sessions per week for 4 weeks. Cognitive training will be completed in the presence of a research assistant who will monitor engagement/adherence with the training. The computerised tasks are designed to target attention, processing speed and memory.
Control group
Active

Outcomes
Primary outcome [1] 295119 0
MATRICS Consensus battery
The MATRICS battery is a multi-domain cognitive battery specifically designed for repeated use. We will be
assessing the domains of speed of processing, attention, verbal learning, working memory, visual learning, reasoning, and problem solving.
Although all of these domains are measured separately by the MATRICS, it also allows for a Global Cognition score to be calculated.
This is a composite primary outcome.
Timepoint [1] 295119 0
Baseline and Endpoint (i.e. pre and post 20 sessions of tDCS stimulation)
Secondary outcome [1] 314810 0
TMS-EEG data.
TMS-EEG is performed by stimulating the scalp over the DLPFC while
simultaneously recording brain activity via surrounding EEG electrodes.
The TMS pulse produces a neurophysiological response in the underlying cortex, referred to as a TMS evoked potential (TEP), which is recorded onEEG and the TEP amplitude gives an index of cortical excitability.
Timepoint [1] 314810 0
Baseline and Endpoint (i.e. pre and post 20 sessions of tDCS)

Eligibility
Key inclusion criteria
Participants will be included if they: (1) are aged 18-65 and have capacity to consent; (2) have experienced a closed head injury of mild to moderate severity determined by patient reports and hospital records of a loss of consciousness (LOC) of less than 24 hours, and an initial GCS of more than 9 ; (3) are at least 6 weeks post injury to allow a degree a recovery from injuries sustained from the TBI prior to entering the trial; (4) have an IQ of greater than 70 as determined by performance on the Wechsler Test of Adult Reading (WTAR) (to ensure they understand the study requirements) ; (5) exhibit cognitive impairment, defined as a performance greater than 1 SD below published norms on any domain within the MATRICS.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they (1) have a diagnosis of a Psychiatric illness, lifetime (i.e. either pre or post TBI). In particular, as rTMS is known to effectively treat depression and this may impact upon the outcome variables, the presence of a depressive disorder (DSM 5 criteria) will exclude participation; (2) have drug dependence or abuse; (3) have a personal or family history of a seizure disorder; (4) an unstable medical condition, neurological disorder, are currently pregnant or lactating; (5) have metal in the cranium, a pacemaker, cochlear implant, medication pump or other electronic device.

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)
Allocation is concealed; by the research assistant contacting the principal investigator who has a computer generated random sequence for treatment groups after the participant is deemed eligible and has consented for the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
10/06/2015
Actual
10/07/2015
Date of last participant enrolment
Anticipated
Actual
15/12/2015
Date of last data collection
Anticipated
Actual
15/12/2015
Sample size
Target
20
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291309 0
Government body
Name [1] 291309 0
National Health and Medical Research Council, RD Wright Biomedical Career Development Fellowship
Country [1] 291309 0
Australia
Funding source category [2] 291310 0
University
Name [2] 291310 0
Monash University
Country [2] 291310 0
Australia
Primary sponsor type
Individual
Name
Dr Kate Hoy
Address
MAPrc,
Level 4,
607 St Kilda Road,
Melbourne,
3004,
VIC
Country
Australia
Secondary sponsor category [1] 289989 0
University
Name [1] 289989 0
Monash University
Address [1] 289989 0
Monash University
Victoria 3800
Australia
Country [1] 289989 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292875 0
Alfred Health Ethics Committee
Ethics committee address [1] 292875 0
Ground Floor, Linay Pavilion, The Alfred Hospital, 55 Commercial Rd, Melbourne VIC 3004,
Ethics committee country [1] 292875 0
Australia
Date submitted for ethics approval [1] 292875 0
Approval date [1] 292875 0
08/05/2015
Ethics approval number [1] 292875 0
123/15

Summary
Brief summary
Traumatic Brain Injury (TBI) can lead to fundamental changes in a person’s ability to function day-to-day. The development of cognitive impairment is a particularly common and disabling consequence. As such, rehabilitation of cognition is an important part of post head injury treatment but current standard cognitive rehabilitation (consisting of either re-training / remediating impaired abilities) has generally resulted in only modest improvements in functioning.
Our study will explore an innovative approach to repairing cognitive functioning following TBI that combines biological modulation of neural systems with behavioural remediation. We will combine transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, with cognitive training and examine the effectiveness of this combination using a Randomised Controlled Trial design. The ultimate aim of this research is the development of an effective targeted treatment for cognitive impairment following TBI to allow for a more complete recovery following injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57454 0
Dr Kate Hoy
Address 57454 0
MAPrc, Level 4, 607 St Kilda Road, Melbourne, 3004 VIC
Country 57454 0
Australia
Phone 57454 0
+613 9076 5034
Fax 57454 0
Email 57454 0
[email protected]
Contact person for public queries
Name 57455 0
Dr Kate Hoy
Address 57455 0
MAPrc
Level 4,
607 St Kilda Road,
Melbourne,
3004
VIC
Country 57455 0
Australia
Phone 57455 0
+613 9076 5034
Fax 57455 0
Email 57455 0
[email protected]
Contact person for scientific queries
Name 57456 0
Dr Kate Hoy
Address 57456 0
MAPrc
Level 4,
607 St Kilda Road,
Melbourne,
3004
VIC
Country 57456 0
Australia
Phone 57456 0
+613 9076 5034
Fax 57456 0
Email 57456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.