tDCS + Cognitive Training for Improved Decision Making

(tDCS-CTDM Trial)

Overseen By Najat Khalifa, MD, FRCPC

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Najat Khalifa

Must not be taking: Psychotropic medications

Disqualifiers: Epilepsy, Neurological conditions, Substance misuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 20 minutes per session

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of brain stimulation and cognitive exercises to determine if it helps improve decision-making and impulse control. Participants will receive either active brain stimulation (anodal transcranial Direct Current Stimulation, or tDCS) or a sham (fake) version while performing a decision-making task. The goal is to enhance decision-making skills and reduce impulsive actions. Suitable candidates have no history of neurological issues, substance misuse, or major mental health problems. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance cognitive health.

Will I have to stop taking my current medications?

The trial excludes individuals who are taking psychotropic medication (drugs that affect mood, perception, or behavior), so you would need to stop taking these medications to participate.

What prior data suggests that this combination of tDCS and cognitive training is safe?

Research has shown that using transcranial direct current stimulation (tDCS) with cognitive training is generally safe and well-tolerated. One study found no major unexpected medical problems with this method. Another review confirmed that tDCS does not cause serious side effects, such as brain tissue injury. These findings suggest that participants can expect a safe experience with this treatment approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining transcranial Direct Current Stimulation (tDCS) with cognitive training because it offers a unique, non-invasive approach to potentially enhance decision-making skills. While traditional treatments for decision-making deficits might involve medications or behavioral therapies, this method uses a mild electrical current to stimulate brain activity directly during cognitive tasks. This innovative technique could lead to quicker and more targeted improvements compared to standard therapies, offering new hope for individuals looking to boost their cognitive performance.

What evidence suggests that this trial's treatments could be effective for improving decision-making and impulse control?

This trial will compare the effects of combined anodal tDCS and cognitive training with combined sham tDCS and cognitive training. Studies have shown that anodal tDCS, when paired with mental exercises, can enhance decision-making. Research indicates that individuals receiving this treatment tend to make smarter choices in tasks like the Iowa Gambling Task. Specifically, one study found that participants who received anodal tDCS improved their decision-making, particularly in risky situations. Another study demonstrated that this treatment helped sports referees make better decisions in sensitive situations. These findings suggest that this combined approach could enhance impulse control and decision-making. ^{6 7 8 9 10}

Who Is on the Research Team?

Najat Khalifa, MD

Principal Investigator

Queen's University - Canada

Are You a Good Fit for This Trial?

This trial is for consenting adults aged 18 to 40 who want to help study decision-making and impulsivity. It's not suitable for those with epilepsy, other neurological conditions, significant head injury history, substance misuse issues, major mental disorders, or those on psychotropic medication.

Exclusion Criteria

Individuals with a history of substance misuse

I am taking medication for my mental health.

I have epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham tDCS while completing cognitive training tasks

20 minutes per session

Multiple sessions (in-person)

Follow-up

Participants are monitored for changes in decision-making and impulsivity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anodal transcranial Direct Current Stimulation (tDCS)
• Cognitive training
• Sham transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests if brain stimulation (anodal tDCS) combined with cognitive training improves decision-making and impulse control compared to a fake treatment (sham tDCS). Participants will do tasks like the Iowa Gambling Task while receiving these treatments.

How Is the Trial Designed?

Group I: Combined anodal tDCS and cognitive training Experimental Treatment 2 Interventions

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.

Group II: Combined sham tDCS and cognitive training Placebo Group 2 Interventions

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 Is Running the Clinical Trial?

Dr. Najat Khalifa

Lead Sponsor

Trials

2

Recruited

120+

Dr. Najat Khalifa

Lead Sponsor

Trials

2

Recruited

120+

University of Nottingham

Collaborator

Trials

540

Recruited

2,317,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) applied to the left prefrontal cortex during decision-making training significantly enhanced cognitive performance, with benefits observed for both trained and untrained tasks.

The study suggests that anodal tDCS increases the brain's rate of evidence accumulation, indicating a mechanism by which brain stimulation can enhance cognitive training outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in Attention and Decision-Making Following Combined Behavioral Training and Brain Stimulation. Filmer, HL., Varghese, E., Hawkins, GE., et al.[2018]

In a study involving 14 older individuals with HIV-related mild neurocognitive disorder, both cognitive training and transcranial direct current stimulation (tDCS) were well accepted, with most participants believing the intervention improved their cognitive function.

While the results did not show statistically significant improvements, 12 out of 13 measures favored tDCS, suggesting it may have potential benefits for cognitive function in older adults with HIV, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of cognitive training with and without transcranial direct current stimulation to improve cognition in older persons with HIV-related cognitive impairment. Ownby, RL., Acevedo, A.[2020]

In a study involving 32 patients with severe traumatic brain injury (TBI), those who received 10 sessions of transcranial direct current stimulation (tDCS) combined with cognitive training showed significant improvements in divided attention performance, including faster reaction times and fewer omissions.

Functional MRI results indicated that the tDCS treatment led to a normalization of brain activity, with reduced hyperactivation in several areas associated with cognitive function, suggesting that this approach may effectively aid recovery in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant Use of Transcranial Direct Current Stimulation and Computer-Assisted Training for the Rehabilitation of Attention in Traumatic Brain Injured Patients: Behavioral and Neuroimaging Results. Sacco, K., Galetto, V., Dimitri, D., et al.[2022]

A systematic review of 15 studies involving 629 participants found that combining cognitive training with active transcranial direct current stimulation (tDCS) showed a small but significant improvement in attention and working memory.

While the combined treatment did not show significant effects on global cognition and language, the results suggest potential efficacy, highlighting the need for more targeted research to better align cognitive training types with specific outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Cognitive Training and Transcranial Direct Current Stimulation in Neuropsychiatric Disorders: A Systematic Review and Meta-analysis. Burton, CZ., Garnett, EO., Capellari, E., et al.[2023]

Transcranial direct current stimulation (tDCS) was found to be safe and well-tolerated in a study involving 20 patients with mild or major neurocognitive disorders, with an attrition rate of 0% and no serious adverse events reported.

However, the study did not find any statistically significant improvements in cognitive functioning when comparing the active tDCS group to the sham group, indicating that tDCS may not enhance cognitive performance in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. Inagawa, T., Yokoi, Y., Narita, Z., et al.[2022]

Transcranial direct current stimulation (tDCS) applied to the prefrontal cortex can enhance cognitive performance, particularly in decision-making tasks, with optimal stimulation intensities of 0.7 mA and 1.0 mA showing the greatest benefits for trained tasks among 123 participants.

The study found that too little or too much stimulation (like sham or 2.0 mA) can hinder performance, indicating a non-linear relationship between stimulation intensity and cognitive efficiency, which also positively affects untrained tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS augments decision-making efficiency in an intensity dependent manner: A training study. Ehrhardt, SE., Ballard, T., Wards, Y., et al.[2022]

Transcranial direct current stimulation (tDCS) applied to the right inferior frontal gyrus (rIFG) combined with cognitive training significantly enhances behavioral inhibition performance, as shown in a study with 22 participants over four days of training.

The results indicate that this combined approach not only improves learning and performance on a stop signal task but also suggests potential therapeutic applications for cognitive control issues in conditions like ADHD and schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulating behavioral inhibition by tDCS combined with cognitive training. Ditye, T., Jacobson, L., Walsh, V., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

In a study involving 60 healthy participants, those who received active transcranial direct current stimulation (tDCS) combined with cognitive training (CT) showed improved accuracy on cognitive tasks compared to those who received sham tDCS, indicating that tDCS can enhance cognitive performance during training.

At a 4-week follow-up, participants who had the active tDCS combined with CT demonstrated greater improvements in attention and working memory on non-trained tasks compared to those who only received tDCS, suggesting that tDCS may enhance the benefits of cognitive training beyond the immediate task.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can transcranial direct current stimulation enhance outcomes from cognitive training? A randomized controlled trial in healthy participants. Martin, DM., Liu, R., Alonzo, A., et al.[2022]

Bifrontal transcranial direct current stimulation (tDCS) is safe and does not cause significant adverse effects in healthy subjects, indicating its feasibility for further research.

While bifrontal stimulation did not enhance working memory performance, it was associated with a reduction in task-related fatigue, suggesting potential benefits for maintaining vigor during cognitive tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Bilateral Anodal Stimulation of the Prefrontal Cortex Using High-Definition Electrodes in Healthy Participants. Xu, J., Healy, SM., Truong, DQ., et al.[2020]

This study will evaluate the safety and efficacy of transcranial direct current stimulation (tDCS) combined with cognitive tasks in patients with neurocognitive disorders, using a randomized controlled trial design with 92 participants (46 per group).

The primary outcome will be measured by changes in cognitive function using the Alzheimer Disease Assessment Scale, with additional assessments for depressive symptoms and quality of life, providing a comprehensive evaluation of tDCS effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of multisession transcranial direct current stimulation as an augmentation to cognitive tasks in patients with neurocognitive disorders in Japan: a study protocol for a randomised controlled trial. Inagawa, T., Yokoi, Y., Yamada, Y., et al.[2021]

Combining anodal transcranial direct current stimulation (tDCS) with multitasking training can improve performance not only on the trained task but also on untrained multitasking and visual search tasks, indicating a broader benefit of this approach.

However, the training did not enhance performance on tasks requiring response inhibition, suggesting that the benefits of tDCS may be specific to certain cognitive functions rather than universally applicable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anodal tDCS applied during multitasking training leads to transferable performance gains. Filmer, HL., Lyons, M., Mattingley, JB., et al.[2019]

Anodal transcranial direct current stimulation (a-tDCS) significantly improved cognitive functions in multiple sclerosis (MS) patients compared to a sham treatment, with effects persisting for some tasks during follow-up.

While cognitive training alone showed immediate benefits in attention and inhibitory control, these improvements did not last, indicating that a-tDCS may be a more effective long-term intervention for enhancing cognitive performance in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of anodal tDCS and cognitive training on cognitive functions in multiple sclerosis; a randomized, double-blind, parallel-group study. Simani, L., Roozbeh, M., Shojaei, M., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) and Cognitive Remediation (CR) can be effectively administered at home, as indicated by a systematic review of 39 studies involving various participant numbers, primarily focusing on conditions like schizophrenia and multiple sclerosis.

The review highlights that remote delivery of these interventions is feasible and supported by technology, suggesting a promising avenue for at-home treatment options for cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of remotely supervised transcranial direct current stimulation and cognitive remediation: A systematic review. Gough, N., Brkan, L., Subramaniam, P., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03886025

Combined Anodal Transcranial Direct Current Stimulation ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10224116/

Anodal Transcranial Direct Current Stimulation over the Right ... The results suggest that the a-tDCS improved factors related to sensitive decision making in female team sports referees.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0166432819313518

Transcranial direct current stimulation improves risky ... According to literature, in the first phase, results showed that men outperformed women in the IGT. In the second phase, the stimulation varied ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03477799

The Effect of Transcranial Direct Current Stimulation on ... Higher scores in the task represents better decision making and healthy people generally have scores above 8-10 in the task. Baseline, after tDCS treatment.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10136466/

High-Definition Transcranial Direct Current Stimulation ... Behavioral changes were found that showed anodal HD-tDCS could improve the decision-making function, in which participants could make more ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6742726/

A Randomized Sham-Controlled Pilot Study These findings suggest that tDCS is safe and tolerable but causes no statistically significant cognitive effects in patients with mild or major ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034822008963

The effectiveness of anodal tDCS and cognitive training on ... This study aims to determine whether multi-session a-tDCS with or without cognitive training impacts cognitive performance in MS.

8. nature.com nature.com/articles/s41537-025-00647-5

Investigating the effects of transcranial direct current ... Anodal tDCS significantly improved working memory performance during training, with gains partially sustained at follow-ups. Short-term transfer ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... In this review, tDCS safety indicates the absence of a Serious Adverse Effect including brain tissue injury related to tDCS application. It is necessary to ...

10. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2021.713792/full

Effect of Anodal Transcranial Direct Current Stimulation ... There were no major adverse events after tDCS. The combined application of tDCS and cognitive training was feasible and associated with improvements in ...