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Clinical Trials/NCT03886025
NCT03886025
Recruiting
Not Applicable

The Use of Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Modulate Decision-making in Healthy People

Dr. Najat Khalifa1 site in 1 country60 target enrollmentSeptember 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Impulsivity
Sponsor
Dr. Najat Khalifa
Enrollment
60
Locations
1
Primary Endpoint
Iowa Gambling Task (IGT) net scores
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2022
End Date
December 30, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr. Najat Khalifa
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Najat Khalifa

Associate Professor

Queen's University

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.

Outcomes

Primary Outcomes

Iowa Gambling Task (IGT) net scores

Time Frame: Change 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 Outcomes

  • Stop Signal Task (SST) reaction time(Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation)
  • Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score(Baseline)
  • Urgency, Perseveration, Premeditation, Sensation Seeking + Positive Urgency (UPPS+P) Impulsive Behavior Scale total scores(Baseline)

Study Sites (1)

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