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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01733602




Registration number
NCT01733602
Ethics application status
Date submitted
26/11/2012
Date registered
27/11/2012
Date last updated
8/08/2017

Titles & IDs
Public title
tDCS to Enhance Cognitive Training in Schizophrenia
Scientific title
Does Transcranial Direct Current Stimulation (tDCS) Enhance Outcomes From Computerised Cognitive Remediation in Patients With Schizophrenia?
Secondary ID [1] 0 0
11/188
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
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 [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression score on cognitive training task.
Timepoint [1] 0 0
Post treatment

Eligibility
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
consent.

4. Subjects are right-handed.

5. Subjects able to give informed consent for the trial.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
risk.

4. Clinically defined neurological disorder or insult, including history of seizures,
cerebral aneurysm or trauma, significant head trauma with loss of consciousness for =
30 minutes.

5. Subject has metal in the cranium, skull defects, or skin lesions on scalp at proposed
electrode sites.

6. Female subject of child bearing age, sexually active and not using reliable
contraception

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital - Sydney
Recruitment postcode(s) [1] 0 0
2229 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01733602
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01733602