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Trial registered on ANZCTR


Registration number
ACTRN12616000014459
Ethics application status
Approved
Date submitted
25/03/2015
Date registered
12/01/2016
Date last updated
1/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the neurobiological and neurocognitive effects of repeated sessions of transcranial direct current stimulation (tDCS) in schizophrenia.
Scientific title
Investigating the neurobiological and neurocognitive effects of repeated sessions of tDCS and itDCS in schizophrenia.
Secondary ID [1] 286405 0
Nil known
Universal Trial Number (UTN)
U1111-1168-6162
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
294561 0
Condition category
Condition code
Mental Health 294868 294868 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo repeated sessions (5 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 three conditions;
1. Five sessions of 20 minute active tDCS to the left Dorsolateral Prefrontal Cortex (DLPFC) at a current density of 0.0057 ma/cm within a single week on consecutive days.

2. Five sessions of 20 minute active itDCS to the left DLPFC at a current density of 0.0057 ma/cm within a single week on consecutive days.

3. Five sessions of 20 minute sham tDCS to the left DLPFC at a current density of 0.0057 ma/cm within a single week on consecutive days.
Intervention code [1] 291476 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.
Control group
Placebo

Outcomes
Primary outcome [1] 294619 0
MATRICS Consensus battery
The MATRICS battery was developed by a panel of experts to measure the most commonly impaired skills in patients with SCZ, it 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] 294619 0
Baseline, Endpoint (i.e. pre and post 5 sessions of tDCS stimulation) and One Month Follow Up
Secondary outcome [1] 313729 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 on EEG and the TEP amplitude gives an index of cortical excitability.
Timepoint [1] 313729 0
Baseline and Endpoint (i.e. pre and post 5 sessions of tDCS)

Eligibility
Key inclusion criteria
- competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study, as assessed by a clinical staff member independent of the research project
- have a diagnosis of schizophrenia or schizoaffective disorder as confirmed by the MINI
- are between the ages of 18 and 60
- have been on a stable dose of medication for at least 4 weeks
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- have a DSM-IV history of substance abuse or dependence in the last 6 months
- have a concomitant major and unstable medical or neurological illness
- are pregnant
- are currently taking any medication shown to interfere with the effects of tDCS; namely benzodiazepines or tegretol.

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
Data Analysis: Neurocognitive data will be analysed using linear mixed-effects modeling (participant as random effect) of the group x time interaction. If a significant interaction between stimulation type and time is observed, post-hoc between-group comparisons of the change will occur. The dependent variables will be the MATRICS (H1: Global Cognition Score, H2: Domain Scores). Neurobiological data will again be conducted using linear mixed-effects modeling as described above. Dependent variables will be TEPs, coherence at rest and during the cognitive task. Finally, to assist our understanding of how changes in functional connectivity are associated with the observed changes in cognitive performance, changes in EEG coherence will be correlated with changes in MATRICS scores. In all cases, p-values <0.05 will be considered significant.

Power Analysis: The study is powered to detect a significant difference in the cognitive outcome measure, i.e. MATRICS Global Cognition Score. Our pilot data showed that single session tDCS had a moderate effect size on cognition (Cohen’s d = 0.50-0.56). Therefore, in the proposed study we are predicting that repeated sessions of tDCS will result in a moderate to large effect size (d = 0.70); using this effect size a sample of 60 will provide greater than 80% power with an alpha of 0.05 in a Repeated Measures ANOVA.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290973 0
Government body
Name [1] 290973 0
National Health and Medical Research Council, RD Wright Biomedical Career Development Fellowship
Address [1] 290973 0
National Health and Medical Research Council
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 290973 0
Australia
Funding source category [2] 290974 0
University
Name [2] 290974 0
Monash University
Address [2] 290974 0
Monash University
Victoria 3800
Australia
Country [2] 290974 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] 290031 0
University
Name [1] 290031 0
Monash University
Address [1] 290031 0
Monash University
Victoria 3800
Australia
Country [1] 290031 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292568 0
Alfred Health Ethics Committee
Ethics committee address [1] 292568 0
Ground Floor, Linay Pavilion, The Alfred Hospital, 55 Commercial Rd, Melbourne VIC 3004,
Ethics committee country [1] 292568 0
Australia
Date submitted for ethics approval [1] 292568 0
Approval date [1] 292568 0
19/01/2015
Ethics approval number [1] 292568 0
528/14

Summary
Brief summary
People with schizophrenia can experience difficulties with attention, concentration and memory; these are referred to as cognitive symptoms. There are currently no effective treatments for these symptoms. We are investigating whether non-invasive brain stimulation, specifically transcranial Direct Current Stimulation (tDCS), is able to improve cognition in individuals with schizophrenia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55994 0
A/Prof Kate Hoy
Address 55994 0
MAPrc,
Level 4,
607 St Kilda Road,
Melbourne,
3004
VIC
Country 55994 0
Australia
Phone 55994 0
+613 9076 5034
Fax 55994 0
Email 55994 0
kate.hoy@monash.edu
Contact person for public queries
Name 55995 0
A/Prof Kate Hoy
Address 55995 0
MAPrc,
Level 4,
607 St Kilda Road,
Melbourne,
3004
VIC
Country 55995 0
Australia
Phone 55995 0
+613 9076 5034
Fax 55995 0
Email 55995 0
kate.hoy@monash.edu
Contact person for scientific queries
Name 55996 0
A/Prof Kate Hoy
Address 55996 0
MAPrc,
Level 4,
607 St Kilda Road,
Melbourne,
3004
VIC
Country 55996 0
Australia
Phone 55996 0
+613 9076 5034
Fax 55996 0
Email 55996 0
kate.hoy@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary