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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/NCT01733576




Registration number
NCT01733576
Ethics application status
Date submitted
26/11/2012
Date registered
27/11/2012
Date last updated
23/07/2015

Titles & IDs
Public title
High-definition Transcranial Direct Current Stimulation (HD-tDCS) Verbal Learning
Scientific title
Enhancing Verbal Learning and Memory Using High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
Secondary ID [1] 0 0
CB64
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Verbal Learning and Memory 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - HD-tDCS

Sham Comparator: Sham HD-tDCS -

Active Comparator: Active HD-tDCS 1 -

Active Comparator: Active HD-tDCS 2 -

Active Comparator: Active HD-tDCS 3 -


Treatment: Devices: HD-tDCS
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ray Auditory Verbal Learning Test (RAVLT)
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Ages 18 - 40 years

- Right-handed
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
Phase 0
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute - 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
This project will use a new form of non-invasive brain stimulation called high-definition
transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of
stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more
spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the
brain important for learning and memory will improve verbal learning and memory compared to
sham HD-tDCS.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01733576
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/NCT01733576