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/NCT01339585




Registration number
NCT01339585
Ethics application status
Date submitted
1/04/2011
Date registered
20/04/2011
Date last updated
12/08/2014

Titles & IDs
Public title
The Effect of Timing of Transcranial Direct Current Stimulation (tDCS) for Enhancing Learning During Cognitive Training
Scientific title
The Effect of Timing of Transcranial Direct Current Stimulation (tDCS) for Enhancing Learning During Cognitive Training
Secondary ID [1] 0 0
HREC 11064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effects on Learning 0 0
Condition category
Condition code

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

Experimental: Timing of tDCS -

Experimental: Alternative timing of tDCS -


Treatment: Devices: Transcranial direct current stimulation (tDCS)
Eldith Direct Current Stimulator (NeuroConn GmbH, Germany)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in performance across each condition.
Timepoint [1] 0 0
Over 2 days, with each condition conducted 1 month apart.

Eligibility
Key inclusion criteria
- Participants will be healthy right-handed subjects aged 18 to 40 years.
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,

- Current history of drug or alcohol abuse or dependence,

- 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
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


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
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
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
School of Psychiatry - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
This project will investigate a novel strategy for enhancing cognitive training (CT).
Specifically, the investigators aim to combine a non-invasive form of brain stimulation
(tDCS) with CT. This study will examine the optimal time interval - whether tDCS should be
administered either before or during CT.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01339585
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/NCT01339585