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NCT Number: NCT03886025

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University

Kingston, Ontario, K7L7X3, Canada

Location status: Recruiting

Location contact

Katy Jones, PhD

SUB_INVESTIGATOR

Najat Khalifa, MD, FRCPC

CONTACT

[email protected]

6135444900

Najat Khalifa, MD, FRCPC

PRINCIPAL_INVESTIGATOR

Peter Liddle, PhD

SUB_INVESTIGATOR

Roumen Milev, PhD

SUB_INVESTIGATOR

Tariq Hassan, FRCPSC

CONTACT

[email protected]

6135444900

Tariq Hassan, FRCPSC

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anodal transcranial Direct Current Stimulation (tDCS)

Other

Non-invasive brain stimulation

Cognitive training

Behavioral

Iowa Gambling Task will be used for cognitive training

Sham transcranial Direct Current Stimulation (tDCS)

Other

Non-invasive brain stimulation

Primary outcomes

  1. 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

  1. Stop Signal Task (SST) reaction time

    Time frame: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation

    SST is a measure of inhibitory control

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

    Time frame: Baseline

    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.

  3. Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Najat Khalifa, MD, FRCPC

CONTACT

[email protected]

6135444900

Tariq Hassan, FRCPSC

CONTACT

[email protected]

6135444900

Sponsors and collaborators

Lead sponsor

Dr. Najat Khalifa

Other

Collaborators

  • University of Nottingham

Registry information

Official study title

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

Acronym: tDCS-CTDM

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2019
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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