Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01333306




Registration number
NCT01333306
Ethics application status
Date submitted
7/04/2011
Date registered
11/04/2011
Date last updated
24/04/2013

Titles & IDs
Public title
Enhancing Cognitive Training Using tDCS
Scientific title
Secondary ID [1] 0 0
10269
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Transcranial direct current stimulation (tDCS)

Experimental: tDCS and cognitive training -


Treatment: Surgery: Transcranial direct current stimulation (tDCS)
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Participants will be healthy right-handed subjects aged 18 to 40
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Concurrent medication likely to affect mental performance

- History of drug or alcohol abuse or dependence current or in the last 3 months

- Any psychiatric or neurological disorder, recent head injury, or history of seizure or
stroke

Study design
Purpose of the study
Basic Science
Allocation to intervention
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?



Intervention assignment
Other design features
Phase
Phase 1
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
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute Building - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
Cognitive rehabilitation involves enhancing an individual's capacity to process information
to improve their everyday functioning. One common form of intervention is computerised
cognitive training (CT); however, efficacy results have been mixed. This research aims to
investigate a novel method for enhancing outcomes from CT through combining CT with
transcranial direct current stimulation (tDCS), a non-invasive and painless form of brain
stimulation. In this study we aim to determine the efficacy of this approach through
comparing in a randomized controlled study tDCS combined with CT versus CT and tDCS alone in
healthy participants. We hypothesise that tDCS combined with CT will have greater
generalisability effects than the other conditions.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01333306
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/NCT01333306