ImpulsivitytDCS-CTDMNCT03886025
Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training and Decision-making
A study testing Anodal transcranial Direct Current Stimulation (tDCS) and Cognitive training in people with Impulsivity and Decision Making, run by Dr. Najat Khalifa at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Impulsivity, Decision Making
- What is being tested?
- Anodal transcranial Direct Current Stimulation (tDCS) and Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2022to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consenting volunteers aged between 18 and 40.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Queen's University
Kingston, Ontario, K7L7X3
Najat Khalifa, MD, FRCPC, 6135444900, nrk2@queensu.ca
Tariq Hassan, FRCPSC, 6135444900, hassant@providencecare.ca
About this study
Official title: The Use of Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Modulate Decision-making in Healthy People
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.
- Conditions
- Impulsivity, Decision Making
- Being tested
- Anodal transcranial Direct Current Stimulation (tDCS), Cognitive training, Sham transcranial Direct Current Stimulation (tDCS)
- Keywords
- transcranial Direct Current Stimulation (tDCS), Decision-making, Implusivity, Brain stimulation
- Medical subject headings
- Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal transcranial Direct Current Stimulation (tDCS)Other
Non-invasive brain stimulation
Cognitive trainingBehavioural
Iowa Gambling Task will be used for cognitive training
Sham transcranial Direct Current Stimulation (tDCS)Other
Non-invasive brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| Combined anodal tDCS and cognitive training | Experimental | 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. Receives: Other: Anodal transcranial Direct Current Stimulation (tDCS); Behavioral: Cognitive training |
| Combined sham tDCS and cognitive training | Sham comparator | 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. Receives: Behavioral: Cognitive training; Other: Sham transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iowa Gambling Task (IGT) net scores
IGT is a measure of decision making under conditions of uncertainty and risk.
Measured: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
Secondary outcomes (3)
Stop Signal Task (SST) reaction time
SST is a measure of inhibitory control
Measured: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start15 Sep 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpulsivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Najat Khalifa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor-investigator, Dr. Najat Khalifa, Queen's University
- Investigators
- Najat Khalifa, MD, Principal investigator, Queen's University - Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886025
- Sponsor's protocol ID
- 6025821
- Acronym
- tDCS-CTDM
- Status last verified
- Aug 2025
- First submitted
- 15 Mar 2019
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data will be shared with researchers other than the study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Modulate Decision-making in Healthy People
- ClinicalTrials.gov ID
- NCT03886025
- Acronym / sponsor ID
- tDCS-CTDM / 6025821
- Conditions
- Impulsivity, Decision Making
- Keywords
- transcranial Direct Current Stimulation (tDCS), Decision-making, Implusivity, Brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Najat KhalifaUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Combined anodal tDCS and cognitive training | Experimental | Other: Anodal transcranial Direct Current Stimulation (tDCS), Behavioral: Cognitive 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 training | Sham comparator | Behavioral: Cognitive training, Other: Sham 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Consenting volunteers aged between 18 and 40.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal transcranial Direct Current Stimulation (tDCS)Non-invasive brain stimulation | Other | Combined anodal tDCS and cognitive training |
| Cognitive trainingIowa Gambling Task will be used for cognitive training | Behavioural | Combined anodal tDCS and cognitive training, Combined sham tDCS and cognitive training |
| Sham transcranial Direct Current Stimulation (tDCS)Non-invasive brain stimulation | Other | Combined sham tDCS and cognitive training |
Primary outcome
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.
3 secondary outcomes
Stop Signal Task (SST) reaction time
Time frame: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
Urgency, Perseveration, Premeditation, Sensation Seeking + Positive Urgency (UPPS+P) Impulsive Behavior Scale total scores
Time frame: Baseline
Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No. No participant data will be shared with researchers other than the study investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Najat Khalifa, MD principal investigator
Queen's University - Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal transcranial Direct Current Stimulation (tDCS) and Cognitive training in people with Impulsivity and Decision Making, run by Dr. Najat Khalifa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Najat Khalifa, MD, FRCPC (6135444900, nrk2@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iowa Gambling Task (IGT) net scores (time frame: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.