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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial Direct Current Stimulation (tDCS), a gentle electrical brain stimulation, can enhance motor learning, such as improving the speed and effectiveness of learning new physical skills. Researchers will divide participants into groups, with some receiving tDCS alongside motor training and others receiving only the training. The study aims to determine if expectations about tDCS can also influence its effectiveness. It is suitable for right-handed individuals who have not experienced seizures or head injuries and are not currently using any prescription or recreational drugs. As an unphased trial, this study offers a unique opportunity to contribute to foundational research in brain stimulation and 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 prior data suggests that transcranial Direct Current Stimulation (tDCS) is safe for motor skill improvement?

Research has shown that Transcranial Direct Current Stimulation (tDCS) is generally safe. Studies have used tDCS to enhance movement skills by placing small pads on the head to deliver a gentle electrical current to the brain.

In past research, tDCS combined with movement training improved movement, particularly aiding walking in individuals with Parkinson's disease. Another study found that tDCS helped children with cerebral palsy learn movement skills more effectively.

Importantly, these studies did not report any serious side effects. Some participants experienced slight tingling on the scalp or mild discomfort, but these effects were usually minor and temporary.

Overall, current evidence suggests that tDCS is safe for improving movement skills when used as described in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for motor skill improvement because it offers a non-invasive approach that could enhance motor learning and rehabilitation. Unlike traditional physical therapy, which relies solely on exercises to retrain motor skills, tDCS applies a small electrical current to the scalp to potentially boost brain plasticity and improve the efficiency of motor training. This method could complement existing therapies by accelerating progress and providing a novel mechanism to engage the brain's adaptive capabilities. Additionally, the possibility of using different tDCS protocols, such as varied study materials and stimulation types, allows researchers to explore the best combinations for optimal results.

What evidence suggests that transcranial Direct Current Stimulation (tDCS) is effective for motor skill improvement?

Research has shown that transcranial Direct Current Stimulation (tDCS) can significantly aid in learning motor skills. In this trial, participants in the tDCS1, tDCS2, and tDCS3 arms will receive motor training combined with tDCS. One study found that tDCS enhanced task performance involving specific movements. Another study demonstrated that pairing tDCS with physical training increased activity in brain areas controlling movement, leading to improved movement control. Additional research supports the idea that tDCS can enhance balance by improving how the brain prepares for and executes movements. These findings suggest that tDCS might effectively help people learn and improve motor skills. ^{4 5 6 7 8}

Who Is on the Research Team?

Sydney Schaefer, PhD

Principal Investigator

Arizona State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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Our results showed that tDCS combined with physical training can induce significant increase in MEP (75%, 6 out of the 8 included studies), ...

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In healthy humans, tDCS with the anode placed over the primary motor cortex improves motor skill learning 9,10,23,24.

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Our results suggest that combining motor training with tDCS improves motor function, particularly in gait-related parameters, in PD patients.

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