MedPath

Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training and Decision-making

Not Applicable
Recruiting
Conditions
Impulsivity
Decision Making
Interventions
Behavioral: Cognitive training
Other: Anodal transcranial Direct Current Stimulation (tDCS)
Other: Sham transcranial Direct Current Stimulation (tDCS)
Registration Number
NCT03886025
Lead Sponsor
Dr. Najat Khalifa
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Combined sham tDCS and cognitive trainingCognitive trainingCombined sham tDCS and cognitive training. Sham tDCS will be delivered while the participant is completing the cognitive training task (Iowa Gambling Task). For sham tDCS, the current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. The duration of each tDCS session will be 20 minutes.
Combined anodal tDCS and cognitive trainingCognitive trainingCombined anodal tDCS and cognitive training. Anodal tDCS will be delivered while the participant is completing the cognitive training task (Iowa Gambling Task). Anodal tDCS will use a constant current of 2mA, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively. The duration of each tDCS session will be 20 minutes.
Combined sham tDCS and cognitive trainingSham transcranial Direct Current Stimulation (tDCS)Combined sham tDCS and cognitive training. Sham tDCS will be delivered while the participant is completing the cognitive training task (Iowa Gambling Task). For sham tDCS, the current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. The duration of each tDCS session will be 20 minutes.
Combined anodal tDCS and cognitive trainingAnodal transcranial Direct Current Stimulation (tDCS)Combined anodal tDCS and cognitive training. Anodal tDCS will be delivered while the participant is completing the cognitive training task (Iowa Gambling Task). Anodal tDCS will use a constant current of 2mA, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively. The duration of each tDCS session will be 20 minutes.
Primary Outcome Measures
NameTimeMethod
Iowa Gambling Task (IGT) net scoresChange from baseline after 20 minutes of combined cognitive training and tDCS stimulation

IGT is a measure of decision making under conditions of uncertainty and risk.

Secondary Outcome Measures
NameTimeMethod
Stop Signal Task (SST) reaction timeChange from baseline after 20 minutes of combined cognitive training and tDCS stimulation

SST is a measure of inhibitory control

Abbreviated Profile of Mood States (POMS) Total Mood Disturbance scoreBaseline

Abbreviated POMS is a 40-item measure of current mood states. Each item is rated on a scale of 0-4 (0=Not at all, 4=Extremely). The total Mood Disturbance score is calculated by summing the totals for the negative subscales (tension, depression, anger, fatigue, confusion) and then subtracting the totals for the positive subscales (vigour, esteem related affect) and then adding a constant 100. Higher scores denote greater mood disturbance.

Urgency, Perseveration, Premeditation, Sensation Seeking + Positive Urgency (UPPS+P) Impulsive Behavior Scale total scoresBaseline

UPPS+P is a 59 item self-report measure of trait impulsivity. Each item is rated on a scale of 1-4 (1= totally disagree, 4=totally agree) yielding a total score out of 216 (range=59 - 216) Higher scores denote higher impulsivity.

Trial Locations

Locations (1)

Queen's University

🇨🇦

Kingston, Ontario, Canada

© Copyright 2025. All Rights Reserved by MedPath