tDCS for Motor Skill Improvement

Overseen By Sydney Schaefer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Prescription drugs, Recreational drugs

Disqualifiers: Seizures, Head injury, Migraines, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

128 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test if priming expectations of transcranial Direct Current Stimulation (tDCS) can improve the efficacy of tDCS in enhancing motor learning.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications, as the trial excludes participants who are currently taking prescription medications or are self-medicating, except for the contraceptive pill.

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for motor skill improvement?

Research shows that tDCS can improve motor skills and learning in healthy people and help recover motor function in stroke patients. Studies suggest that higher intensity and specific application methods, like bilateral stimulation, may enhance these effects. ^{1 2 3 4 5}

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

The provided research articles do not contain specific safety information about transcranial direct current stimulation (tDCS) for motor skill improvement or any other conditions. ^{6 7 8 9 10}

How is the treatment tDCS unique for improving motor skills?

Transcranial Direct Current Stimulation (tDCS) is unique because it uses a low-cost, painless, and portable method to apply a weak electrical current through the scalp, which can enhance motor learning by changing the excitability of brain neurons. Unlike other treatments, tDCS can be applied bilaterally to target both sides of the brain, potentially offering superior results in motor skill improvement. ^{1 2 4 11 12}

Research Team

Sydney Schaefer, PhD

Principal Investigator

Arizona State University

Eligibility Criteria

This trial is for right-handed adults who have never had seizures, head injuries with loss of consciousness requiring further investigation, or any implanted devices like pacemakers. It's not for those who are pregnant, ambidextrous, suffer from migraines or psychological/neurological conditions, have metal in their head (except dental), scalp skin conditions, unhealed head wounds, adverse reactions to brain stimulation techniques or currently taking medication/drugs.

Inclusion Criteria

Right-hand dominant

I am over 18 and use my right hand for most tasks.

Exclusion Criteria

You have a wound on your head that is still in the process of healing.

You can use both hands equally well or switch hands easily.

Left-hand dominant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Training

Participants undergo motor training with or without tDCS over three days

1 week

3 visits (in-person)

Follow-up

Participants are monitored for changes in motor performance and expectations one week after the final training session

1 week

1 visit (in-person)

Treatment Details

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study is examining whether setting up positive expectations can boost the effectiveness of transcranial Direct Current Stimulation (tDCS) in improving motor learning skills.

Participant Groups

Group I: tDCS3 Experimental Treatment 1 Intervention

This group will first read some information about tDCS based on cited studies, but different cited studies than the tDCS2 arm. They will then receive the same motor training and tDCS as the tDCS1 and 2 arms.

Group II: tDCS2 Experimental Treatment 1 Intervention

This group will first read some information about tDCS based on cited studies. They will then receive the same motor training and tDCS as the tDCS1 arm.

Group III: tDCS1 Experimental Treatment 1 Intervention

This group will receive motor training concurrent with 20 minutes of either sham or active tDCS. Sham tDCS will be a 30-second ramp up from 0 to 2 milliamps (MA), then a 30-second ramp-down from 2 mA to 0 mA. The next 18 minutes will have no stimulation (0 mA), starting at minute 19 with 30-second ramp up from 0 to 2 milliamps (MA), then a 30-second ramp-down from 2 mA to 0 mA. Active tDCS will ramp up to 2 mA in the first 30 seconds, then stay at 2 mA for 19 minutes, then ramp down to 0 mA.

Group IV: Control Active Control 1 Intervention

This group will only receive motor training, which consists of 10 trials of motor training per day across 3 days, followed by a one-week follow-up of 2 trials.

Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Depression
• Anxiety

Approved in European Union as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Neurological rehabilitation

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Findings from Research

In a study involving 108 healthy participants, anodal transcranial direct current stimulation (tDCS) at 4 mA significantly improved motor learning performance compared to both cathodal stimulation and no stimulation, with a medium to large effect size (Cohen's d = 0.71 and d = 0.56, respectively).

The effects of anodal stimulation not only enhanced performance during the initial task but also facilitated learning of a new sequence and improved performance with the opposite hand, indicating a lasting impact on motor learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robust enhancement of motor sequence learning with 4 mA transcranial electric stimulation. Hsu, G., Shereen, AD., Cohen, LG., et al.[2023]

Transcranial direct current stimulation (tDCS) has shown promising results in enhancing motor learning and improving motor function in both healthy individuals and stroke patients, particularly when combined with targeted training.

tDCS is well tolerated and easy to use, with evidence suggesting that specific timing and electrode configurations can optimize its effectiveness for rehabilitation, although more acute studies in brain injury patients are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of motor performance and motor learning by transcranial direct current stimulation. Reis, J., Fritsch, B.[2022]

In a study involving 56 chronic stroke patients, transcranial direct current stimulation (tDCS) combined with motor training significantly enhanced the learning of a new fine motor skill compared to training alone, particularly during the online learning phase.

While tDCS improved the acquisition of the trained skill, it did not affect long-term retention or the generalization of performance gains to untrained tasks, indicating its benefits are specific to the skill being practiced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Enhances Motor Skill Learning but Not Generalization in Chronic Stroke. Hamoudi, M., Schambra, HM., Fritsch, B., et al.[2020]

Bilateral transcranial direct current stimulation (TDCS) significantly enhances motor learning compared to unilateral TDCS, as shown in a study with 50 healthy participants performing a motor task over three days.

The effectiveness of bilateral TDCS is attributed to its polarity-specific effects on each hemisphere of the brain, rather than the direction of current flow, indicating a more nuanced approach to enhancing motor performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced motor learning with bilateral transcranial direct current stimulation: Impact of polarity or current flow direction? Naros, G., Geyer, M., Koch, S., et al.[2016]

Transcranial direct current stimulation (tDCS) has been shown to significantly enhance motor skills learning in healthy adults, as evidenced by improvements in motor sequence tasks and reduced reaction times across multiple studies.

The review included 11 studies, indicating that tDCS activates key brain regions involved in motor control, such as the primary motor cortex and cerebellum, but highlights the need for more extensive research due to the limited number of studies and small sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation on motor skills learning in healthy adults through the activation of different brain regions: A systematic review. Qi, S., Liang, Z., Wei, Z., et al.[2022]

From 2004 to 2007, there were 1,665 reports of Torsades de Pointes (TdP) linked to 376 different drugs, with amiodarone and methadone being the most frequently reported, indicating their significant association with this serious heart condition.

The study highlights that large databases like the FDA Adverse Event Reporting System are crucial for identifying rare adverse drug reactions, and the unexpected reports for drugs like donepezil, famotidine, and mitoxantrone suggest a need for further investigation into their potential TdP risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-induced torsades de pointes: data mining of the public version of the FDA Adverse Event Reporting System (AERS). Poluzzi, E., Raschi, E., Moretti, U., et al.[2018]

A rare but fatal case of torsade de pointes (TdP) was reported following repeated doses of metoclopramide, leading to ventricular fibrillation.

The case highlights the importance of avoiding multiple doses of metoclopramide in patients with existing risk factors for TdP, emphasizing the need for caution in its administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A fatal case of repeated ventricular fibrillation due to torsade de pointes following repeated administration of metoclopramide. Watanabe, Y., Nakamura, I., Takebayashi, Y., et al.[2022]

Safety pharmacology has evolved significantly since the establishment of the Safety Pharmacology Society in 2000, expanding its focus from primarily drug-induced QT prolongation to a broader assessment of potential adverse effects across various physiological systems.

The discipline now includes core studies on cardiovascular, central nervous system, and respiratory systems, while also incorporating innovative non-clinical models to evaluate drug safety, reflecting advancements in technology and methodology in drug safety testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The shifting landscape of safety pharmacology in 2015. Pugsley, MK., Authier, S., Stonerook, M., et al.[2015]

Incorporating safety pharmacology measurements into repeat-dose toxicity studies can provide more accurate assessments of drug effects over time, as some responses may change with repeated dosing, which single-dose studies might miss.

Despite challenges like the need for specialized expertise and suitable conditions, it is possible to gather valuable safety data without using additional animals by employing unobtrusive methods to assess various physiological functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inclusion of Safety Pharmacology Endpoints in Repeat-Dose Toxicity Studies. Redfern, WS.[2015]

An extensive open-access database was created to track drug-related cases of Torsade de Pointes (TdP), compiling data from 424 papers and 634 case reports, which can help improve risk prediction for this serious heart condition.

Despite no new drugs being withdrawn since 2005 due to TdP, the database aims to enhance the understanding of TdP risk factors by providing detailed information on patient characteristics, drug properties, and clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-access database of literature derived drug-related Torsade de Pointes cases. Krumpholz, L., Wiśniowska, B., Polak, S.[2022]

Transcranial direct-current stimulation (tDCS) is a low-cost and painless technique that can enhance motor learning in healthy individuals and aid recovery in those with motor deficits after brain lesions.

tDCS works by inducing changes in the excitability of cortical neurons, which can lead to both immediate and long-term improvements in motor skills, although there are limitations to its effectiveness that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulating Motor Learning through Transcranial Direct-Current Stimulation: An Integrative View. Ammann, C., Spampinato, D., Márquez-Ruiz, J.[2022]

Cerebellar transcranial direct current stimulation (c-tDCS) significantly improves motor learning in complex tasks, as shown by a study involving 42 young adults practicing an overhand throwing task.

Participants receiving c-tDCS demonstrated a greater reduction in throwing error compared to the SHAM group, both immediately after practice and during a retention test 24 hours later, indicating enhanced skill acquisition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebellar Transcranial Direct Current Stimulation Enhances Motor Learning in a Complex Overhand Throwing Task. Jackson, AK., de Albuquerque, LL., Pantovic, M., et al.[2020]

References

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

Robust enhancement of motor sequence learning with 4 mA transcranial electric stimulation. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Modulation of motor performance and motor learning by transcranial direct current stimulation. [2022]

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

Transcranial Direct Current Stimulation Enhances Motor Skill Learning but Not Generalization in Chronic Stroke. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Enhanced motor learning with bilateral transcranial direct current stimulation: Impact of polarity or current flow direction? [2016]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation on motor skills learning in healthy adults through the activation of different brain regions: A systematic review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Drug-induced torsades de pointes: data mining of the public version of the FDA Adverse Event Reporting System (AERS). [2018]

7. England pubmed.ncbi.nlm.nih.gov

A fatal case of repeated ventricular fibrillation due to torsade de pointes following repeated administration of metoclopramide. [2022]

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

The shifting landscape of safety pharmacology in 2015. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

Inclusion of Safety Pharmacology Endpoints in Repeat-Dose Toxicity Studies. [2015]

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

Open-access database of literature derived drug-related Torsade de Pointes cases. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Modulating Motor Learning through Transcranial Direct-Current Stimulation: An Integrative View. [2022]

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

Cerebellar Transcranial Direct Current Stimulation Enhances Motor Learning in a Complex Overhand Throwing Task. [2020]