Learning; Lack of (Specific)NCT04798105
Predictors of Probabilistic Selection Task Performance
A study testing Effects of tDCS of dlPFC on Probabilistic Selection Task in people with Learning; Lack of (Specific), run by Charles Darwin University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning; Lack of (Specific)
- What is being tested?
- Effects of tDCS of dlPFC on Probabilistic Selection Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Apr 2021to 22 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Charles Darwin University, College of Health & Human Sciences
Darwin, Northern Territory, 0810
Luca Aquili, PhD, +610889456 ext. 6807, luca.aquili@cdu.edu.au
About this study
Official title: Modulation of Probabilistic Selection Task Performance Based on Anodal tDCS of dlPFC, Eye Blink Rate, Extraversion and Impulsiveness
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.
Read the detailed description
The aim of this study is to investigate the effect of a non-invasive, low intensity and risk, brain stimulation technique known as transcranial direct current stimulation (tDCS) on the way people learn in a computer administered cognitive task. This will be achieved by comparing participants' performance on this task after receiving placebo 'sham' tDCS in one experimental session, and real 'treatment' tDCS in another experimental session. Neither the researcher administering the session or the participant will be aware of which form of tDCS is being used. Previous research indicates that tDCS of the left dorsolateral prefrontal cortex brain region stimulates the release of a chemical neurotransmitter, dopamine, that is linked to reward and punishment processing, and implicated in conditions such as addiction and Parkinson's disease.
The computerized cognitive learning task presents participants with pairs of six different symbols and asks them to choose one of these. In the first half of the task, participants receive visual feedback (correct or incorrect; +$0.10 or -$0.10) and the symbols are preprogrammed to be rewarded or punished for. In the second part of the task, participants are tested on the same task but do not receive feedback.
Further, the effect of participants' personality characteristics (specifically extraversion and impulsivity), as well as eye-blink-rate, on cognitive learning performance will be investigated, as this is known to be influenced by tDCS. Past research suggests that people may respond differently to tDCS based on individual differences in these personality traits, that are linked at a brain circuits level. Participants will be assessed on extraversion and impulsivity personality traits using pen and paper, self-report questionnaires. Similarly, eye-blink-rate is linked to the aforementioned brain neurotransmitter, dopamine, and will be assessed by manually counting of blinks in a video recording of the participant focusing on a stationary point.
- Conditions
- Learning; Lack of (Specific)
- Being tested
- Effects of tDCS of dlPFC on Probabilistic Selection Task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of tDCS of dlPFC on Probabilistic Selection TaskBehavioural
Predictors of Probabilistic Selection Task Performance including anodal tDCS of dlPFC, eye blink rate, extraversion and impulsiveness
| Study group | Role | What they receive |
|---|---|---|
| tDCS sham | Sham comparator | Transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) in sham mode. Receives: Behavioral: Effects of tDCS of dlPFC on Probabilistic Selection Task |
| tDCS anodal | Active comparator | Transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) in anodal/excitatory mode. Receives: Behavioral: Effects of tDCS of dlPFC on Probabilistic Selection Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probabilistic Selection Task (PST) performance from pre tDCS to post tDCS
Accuracy (%) and reaction times on the above task
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start12 Apr 2021
- Primary completion22 Oct 2021 (estimated)
- Study completion22 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning; Lack of (Specific)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles Darwin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Aquili, Charles Darwin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798105
- Sponsor's protocol ID
- CDULA2021
- Status last verified
- Jul 2021
- First submitted
- 9 Mar 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Probabilistic Selection Task Performance Based on Anodal tDCS of dlPFC, Eye Blink Rate, Extraversion and Impulsiveness
- ClinicalTrials.gov ID
- NCT04798105
- Acronym / sponsor ID
- CDULA2021
- Conditions
- Learning; Lack of (Specific)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charles Darwin UniversityUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 22 Oct 2021 (estimated)
- Study completion
- 22 Oct 2021 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to investigate the effect of a non-invasive, low intensity and risk, brain stimulation technique known as transcranial direct current stimulation (tDCS) on the way people learn in a computer administered cognitive task. This will be achieved by comparing participants' performance on this task after receiving placebo 'sham' tDCS in one experimental session, and real 'treatment' tDCS in another experimental session. Neither the researcher administering the session or the participant will be aware of which form of tDCS is being used. Previous research indicates that tDCS of the left dorsolateral prefrontal cortex brain region stimulates the release of a chemical neurotransmitter, dopamine, that is linked to reward and punishment processing, and implicated in conditions such as addiction and Parkinson's disease.
The computerized cognitive learning task presents participants with pairs of six different symbols and asks them to choose one of these. In the first half of the task, participants receive visual feedback (correct or incorrect; +$0.10 or -$0.10) and the symbols are preprogrammed to be rewarded or punished for. In the second part of the task, participants are tested on the same task but do not receive feedback.
Further, the effect of participants' personality characteristics (specifically extraversion and impulsivity), as well as eye-blink-rate, on cognitive learning performance will be investigated, as this is known to be influenced by tDCS. Past research suggests that people may respond differently to tDCS based on individual differences in these personality traits, that are linked at a brain circuits level. Participants will be assessed on extraversion and impulsivity personality traits using pen and paper, self-report questionnaires. Similarly, eye-blink-rate is linked to the aforementioned brain neurotransmitter, dopamine, and will be assessed by manually counting of blinks in a video recording of the participant focusing on a stationary point.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS sham | Sham comparator | Behavioral: Effects of tDCS of dlPFC on Probabilistic Selection TaskTranscranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) in sham mode. |
| tDCS anodal | Active comparator | Behavioral: Effects of tDCS of dlPFC on Probabilistic Selection TaskTranscranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) in anodal/excitatory mode. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effects of tDCS of dlPFC on Probabilistic Selection TaskPredictors of Probabilistic Selection Task Performance including anodal tDCS of dlPFC, eye blink rate, extraversion and impulsiveness | Behavioural | tDCS anodal, tDCS sham |
Primary outcome
Change in Probabilistic Selection Task (PST) performance from pre tDCS to post tDCS
Time frame: 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
Accuracy (%) and reaction times on the above task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effects of tDCS of dlPFC on Probabilistic Selection Task in people with Learning; Lack of (Specific), run by Charles Darwin University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Aquili, PhD (+61088946 ext. 6807, luca.aquili@cdu.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probabilistic Selection Task (PST) performance from pre tDCS to post tDCS (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.