Clinical trial NCT03886025: Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training and Decision-making
Official title: The Use of Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Modulate Decision-making in Healthy People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Impulsivity
Decision Making
Keywords: transcranial Direct Current Stimulation (tDCS)
Decision-making
Implusivity
Brain stimulation
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: University of Nottingham
First posted: 2019-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Iowa Gambling Task (IGT) net scores
timeFrame: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
Secondary outcomes:
measure: Stop Signal Task (SST) reaction time
timeFrame: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
measure: Urgency, Perseveration, Premeditation, Sensation Seeking + Positive Urgency (UPPS+P) Impulsive Behavior Scale total scores
timeFrame: Baseline
measure: Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score
timeFrame: Baseline
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University - Canada
name: Najat Khalifa, MD
role: PRINCIPAL_INVESTIGATOR
References: