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RecruitingNCT03886025tDCS-CTDMUpdated Aug 8, 2025

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

An interventional study of Anodal transcranial Direct Current Stimulation (tDCS) and Cognitive training in Impulsivity and Decision Making, sponsored by Dr. Najat Khalifa. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by Dr. Najat Khalifa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Impulsivity
  • Decision Making

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Keywords

  • transcranial Direct Current Stimulation (tDCS)
  • Decision-making
  • Implusivity
  • Brain stimulation
03

In context

Impulsive Behavior

158 studies on the registry are indexed under Impulsive Behavior; 31 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 128 interventional studies indexed under Impulsive Behavior.

Browse Impulsive Behavior studies →

Lead sponsor

Dr. Najat Khalifa is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Consenting volunteers aged between 18 and 40.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Combined anodal tDCS and cognitive training

    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.

    Other: Anodal transcranial Direct Current Stimulation (tDCS) · Behavioral: Cognitive training

  • Sham comparator
    Combined sham tDCS and cognitive training

    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.

    Behavioral: Cognitive training · Other: Sham transcranial Direct Current Stimulation (tDCS)

Interventions

  • OtherAnodal transcranial Direct Current Stimulation (tDCS)

    Non-invasive brain stimulation

  • BehavioralCognitive training

    Iowa Gambling Task will be used for cognitive training

  • OtherSham transcranial Direct Current Stimulation (tDCS)

    Non-invasive brain stimulation

06

What researchers measure

Primary outcomes

  1. Iowa Gambling Task (IGT) net scores

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

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

Secondary outcomes

  1. Stop Signal Task (SST) reaction time

    SST is a measure of inhibitory control

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

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

    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.

    Time frame: Baseline

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

    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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Queen's University
    Kingston, Ontario K7L7X3, Canada
    Recruiting
    • Najat Khalifa, MD, FRCPC · Contactnrk2@queensu.ca · 6135444900
    • Tariq Hassan, FRCPSC · Contacthassant@providencecare.ca · 6135444900
    • Najat Khalifa, MD, FRCPC · Principal investigator
    • Tariq Hassan, FRCPSC · Sub investigator
    • Peter Liddle, PhD · Sub investigator
    • Katy Jones, PhD · Sub investigator
    • Roumen Milev, PhD · Sub investigator
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — No participant data will be shared with researchers other than the study investigators.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2022 (actual). Primary completion is estimated for Dec 2026, 51 months after the start.

Of 55 non-industry interventional studies with no phase under Impulsive Behavior, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 34. This study's planned 51 months is above that.

Counting every sponsor, half of 55 studies reached it within 26 months; a quarter within 13 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2019
First posted
Mar 22, 2019
StartActual
Sep 15, 2022
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2026
Last update
Aug 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03886025
Lead sponsor
Dr. Najat Khalifa
Responsible party
Dr. Najat Khalifa (Associate Professor, Queen's University) — Sponsor-investigator
First posted
Mar 22, 2019
Start date
Sep 15, 2022
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Aug 8, 2025

Study contacts

Najat Khalifa, MD, FRCPC
Contact
nrk2@queensu.ca
6135444900
Tariq Hassan, FRCPSC
Contact
hassant@providencecare.ca
6135444900
Najat Khalifa, MD
principal investigator · Queen's University - Canada

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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