Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training and Decision-making
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anodal transcranial Direct Current Stimulation (tDCS), Cognitive training, Sham transcranial Direct Current Stimulation (tDCS).
- Who it may be relevant to
- Registry conditions: Impulsivity, Decision Making. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Use of Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Modulate Decision-making in Healthy People
Overview
This study aims to (i) assess the effects of combined tDCS and cognitive training on decision-making on a trained task (Iowa Gambling Task; IGT); and (ii) test generalization to a closely related cognitive domain, namely motor impulsivity. It is hypothesized that combined anodal tDCS and cognitive training will result in more advantageous decisions and better impulse control than combined sham tDCS and cognitive training.
Detailed description
Impaired decision-making under conditions of uncertainty and risk has been implicated in maladaptive personality development and violent behaviour. There is a dearth of studies that examined the effects of combined tDCS and cognitive training on decision-making under conditions of uncertainty and risk. It is also unclear if these effects are generalizable to tasks in other domains such as response inhibition (motor impulsivity).
To examine these issues further, a single blind parallel arms randomized controlled trial will be conducted, involving a sample of healthy volunteers aged between 18 and 40. This will entail applying either active or sham tDCS over the anterior frontal cortex (including the vm-PFC) while participants undertake decision-making training using the Iowa Gambling Task. Decision-making will be assessed using the IGT, which is a computerized gambling task used to assess decision-making under conditions of uncertainty and risk. IGT is sensitive to damage to the ventromedial prefrontal cortex (vmPFC), which is considered to play a key role in decision-making. Motor impulsivity will be measured using the Stop Signal Task (SST). The UPPS+P Impulsive Behaviour Scale will be used to index trait impulsivity. The Profile of Mood States will be used to measure state emotion before and after tDCS.
Interventions
- Other Anodal transcranial Direct Current Stimulation (tDCS)
Non-invasive brain stimulation - Behavioral Cognitive training
Iowa Gambling Task will be used for cognitive training - Other Sham transcranial Direct Current Stimulation (tDCS)
Non-invasive brain stimulation
Primary outcome measures
- Iowa Gambling Task (IGT) net scores [Time frame: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation]
Secondary outcome measures (3)
- Stop Signal Task (SST) reaction time [Time frame: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation]
- Urgency, Perseveration, Premeditation, Sensation Seeking + Positive Urgency (UPPS+P) Impulsive Behavior Scale total scores [Time frame: Baseline]
- Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Consenting volunteers aged between 18 and 40.
Exclusion criteria
- Individuals with epilepsy, other neurological conditions and history of significant head injury will be excluded.
- Individuals with a history of substance misuse, major mental disorder and those receiving psychotropic medication will be also excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Queen's University — Kingston
Identifiers
NCT: NCT03886025 · 6025821