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Trial details imported from ClinicalTrials.gov
Ethics application status
tDCS to Enhance Cognitive Training in Schizophrenia
Does Transcranial Direct Current Stimulation (tDCS) Enhance Outcomes From Computerised Cognitive Remediation in Patients With Schizophrenia?
Universal Trial Number (UTN)
Description of intervention(s) / exposure
Treatment: Devices - transcranial direct current stimulation
Experimental: active tDCS and cognitive training - Transcranial direct current stimulation combined with cognitive training
Active Comparator: sham tDCD and cognitive training - Sham transcranial direct current stimulation combined with cognitive training
Treatment: Devices: transcranial direct current stimulation
Intervention code 
Comparator / control treatment
Primary outcome 
Progression score on cognitive training task.
Key inclusion criteria
1. Subjects are 18 years of age or above.
2. Subjects meet criteria for a DSM -IV schizophrenia or schizoaffective disorder but
with a stable mental status as demonstrated by a stable Positive and Negative Symptom
Score (PANSS) score over a period of 2 weeks.
3. Subjects have had no medication changes in the 2 weeks prior to obtaining informed
4. Subjects are right-handed.
5. Subjects able to give informed consent for the trial.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Drug or alcohol abuse or dependence (preceding 3 months).
2. Concurrent anticonvulsant or long acting benzodiazepine medication, as these
medications may interfere with the effects of tDCS.
3. Subject requires a rapid clinical response due to inanition, psychosis or high suicide
4. Clinically defined neurological disorder or insult, including history of seizures,
cerebral aneurysm or trauma, significant head trauma with loss of consciousness for =
5. Subject has metal in the cranium, skull defects, or skin lesions on scalp at proposed
6. Female subject of child bearing age, sexually active and not using reliable
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital - Sydney
Recruitment postcode(s) 
The University of New South Wales
Ethics application status
The primary aim for the study is to determine whether transcranial direct current stimulation
(tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to
determine whether tDCS combined with CT causes larger transferable improvements on
non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are
maintained over time (i.e., maintenance effects).
Specific hypotheses are:
1. CT combined with active tDCS will produce greater training gains on CT tasks compared to
a similar control group receiving CT with sham tDCS.
2. CT combined with active tDCS will produce greater generalisation effects on non-trained
cognitive tasks compared to CT with sham tDCS.
3. The cognitive improvements gained by patients from both interventions will be maintained
over 1 month follow-up.
Trial related presentations / publications