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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/NCT04798105




Registration number
NCT04798105
Ethics application status
Date submitted
9/03/2021
Date registered
15/03/2021
Date last updated
28/07/2021

Titles & IDs
Public title
Predictors of Probabilistic Selection Task Performance
Scientific title
Modulation of Probabilistic Selection Task Performance Based on Anodal tDCS of dlPFC, Eye Blink Rate, Extraversion and Impulsiveness
Secondary ID [1] 0 0
CDULA2021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Learning; Lack of (Specific) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Effects of tDCS of dlPFC on Probabilistic Selection Task

Sham Comparator: tDCS sham - Transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) in sham mode.

Active Comparator: tDCS anodal - Transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) in anodal/excitatory mode.


Behaviour: Effects of tDCS of dlPFC on Probabilistic Selection Task
Predictors of Probabilistic Selection Task Performance including anodal tDCS of dlPFC, eye blink rate, extraversion and impulsiveness
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Probabilistic Selection Task (PST) performance from pre tDCS to post tDCS
Timepoint [1] 0 0
PST is tested prior to tDCS administration at time 0 (baseline) and following tDCS (approximately 50 minutes into the experiment) for both tDCS sham and tDCS anodal

Eligibility
Key inclusion criteria
- Either male or female

- You are aged between 18 and 50 years

- You are in good health

- You agree to fast 3 hours prior to testing
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Suffer from cardiac, hepatic, renal, and/or neurological disorders

- Have damaged or diseased skin on your face and scalp, or a sensitive scalp

- Have a history of alcohol or drug addiction, or severe psychiatric illness

- Are receiving drug treatment which may lower seizure threshold (i.e. epilepsy)

- Are pregnant

- Are sleep deprived (less than 6 hours a day)

- Have metallic dental fillings, orthodontic appliances, a cardiac pacemaker, cochlear
implant, and/or surgical clips

- Have a history of migraine or headaches

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


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/10/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Charles Darwin University, College of Health & Human Sciences - Darwin
Recruitment postcode(s) [1] 0 0
0810 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Charles Darwin University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The project aims to investigate whether tDCS has an effect on reward and punishment learning
sensitivity. Further, whether tDCS will modulate extraversion and impulsivity personality
traits, and eye-blink-rate's effect on learning. For instance, trait extroversion in past
research is linked to the dopamine neurotransmitter system, where it is thought that extreme
low and high levels are detrimental to cognitive performance. Since tDCS has been shown to
increase dopamine levels, it is thought that people who are already high in dopamine may
experience less benefit (or even impairment) on cognitive performance following tDCS.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04798105
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
Luca Aquili, PhD
Address 0 0
Country 0 0
Phone 0 0
+61088946
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04798105