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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Anodal transcranial Direct Current Stimulation (tDCS) combined with Cognitive Training?

Research shows that combining transcranial direct current stimulation (tDCS) with cognitive training can improve cognitive functions in patients with conditions like multiple sclerosis and traumatic brain injury. For example, a study found that patients with traumatic brain injury who received tDCS and cognitive training showed significant improvements in attention and faster reaction times compared to those who received a placebo treatment. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for humans, with no reports of serious adverse effects or irreversible injury across over 33,200 sessions and 1,000 subjects, including vulnerable populations like children and the elderly. ^{2 6 7 8 9}

How does the tDCS + Cognitive Training treatment differ from other treatments for decision-making improvement?

The tDCS + Cognitive Training treatment is unique because it combines brain stimulation (tDCS) with cognitive exercises to enhance decision-making skills. This approach not only improves performance on trained tasks but also shows benefits for untrained tasks, offering a broader enhancement of cognitive functions compared to traditional cognitive training alone. ^{10 11 12 13 14}

Research Team

Najat Khalifa, MD

Principal Investigator

Queen's University - Canada

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 40 years old and agree to participate.

I am between 18 and 40 years old.

Exclusion Criteria

Individuals with a history of substance misuse

I am taking medication for my mental health.

I have epilepsy.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2023]

2. England 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. [2021]

3. Switzerland 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Combined Cognitive Training and Transcranial Direct Current Stimulation in Neuropsychiatric Disorders: A Systematic Review and Meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of remotely supervised transcranial direct current stimulation and cognitive remediation: A systematic review. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Bilateral Anodal Stimulation of the Prefrontal Cortex Using High-Definition Electrodes in Healthy Participants. [2020]

8. New Zealand 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. [2020]

9. Switzerland 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Can transcranial direct current stimulation enhance outcomes from cognitive training? A randomized controlled trial in healthy participants. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Improvements in Attention and Decision-Making Following Combined Behavioral Training and Brain Stimulation. [2018]

12. England pubmed.ncbi.nlm.nih.gov

tDCS augments decision-making efficiency in an intensity dependent manner: A training study. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Modulating behavioral inhibition by tDCS combined with cognitive training. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Anodal tDCS applied during multitasking training leads to transferable performance gains. [2019]