Brain Stimulation + Behavioral Intervention for Motor Skill Learning

(MEM_MOD Trial)

Overseen By Kirstin-Friederike Heise, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Carbamazepine, Flunarizine, Sulpiride, others

Disqualifiers: Pregnancy, Neuromuscular disorders, Seizures, others

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how non-invasive brain stimulation and behavioral interventions change pre-existing motor memories, such as bad posture in golf. It will test whether this combination can help people relearn movements that hinder recovery from issues like chronic pain or post-stroke. Participants will receive either real transcranial alternating current stimulation (tACS) or sham (fake) brain stimulation during memory exercises. Suitable candidates are those without a history of stroke, brain issues, or head trauma and who can type with all their fingers on a computer. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance movement recovery techniques.

Will I have to stop taking my current medications?

If you are taking medications that might interfere with learning or the brain stimulation used in the study, such as carbamazepine, flunarizine, sulpiride, rivastigmine, or dextromethorphan, you may need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that transcranial alternating current stimulation (tACS), a method of gently stimulating the brain from outside the head, is generally safe and well-tolerated. Studies indicate that tACS can effectively enhance motor skills and learning in healthy individuals. It has also been used to boost cognitive abilities, which is important for acquiring new skills.

Although researchers are still testing the treatment for specific purposes, the absence of serious side effects in current research is encouraging. The study's "Not Applicable" phase focuses on understanding the treatment better rather than addressing safety concerns. This often suggests that earlier research has demonstrated the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore a new way to enhance motor skill learning using brain stimulation combined with behavioral interventions. Unlike traditional methods that may rely on physical therapy or medication, transcranial alternating current stimulation (tACS) uses electrical currents to target specific brain areas, potentially improving memory and learning processes more directly. This non-invasive approach could offer a quicker, more targeted method to boost motor skills, which could be especially beneficial for individuals recovering from neurological conditions.

What evidence suggests that this trial's treatments could be effective for motor skill learning?

Research has shown that transcranial alternating current stimulation (tACS), which participants in this trial may receive, can significantly enhance motor skill performance and learning. One study found that tACS helps individuals continue learning effectively despite distractions, which is crucial for relearning skills. Another study discovered that tACS boosts memory and cognitive abilities, both essential for developing motor skills. These findings suggest that tACS might benefit those trying to relearn movements, such as improving posture in sports or music. ^{1 2 4 6 7}

Who Is on the Research Team?

Kirstin-Friederike Heise, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for healthy adults who can use a computer with internet, are 18 or older (with two-thirds being over 60), and can give consent. It's not for pregnant individuals, those with head injuries, brain conditions, metal in the head/neck, severe claustrophobia, neurological disorders, history of seizures or certain medications.

Inclusion Criteria

I have never had a stroke, brain tumor, neurodegenerative disease, or serious head injury.

Access to a personal computer with internet

Ability to give consent for study participation

Exclusion Criteria

Pregnancy

I have a neurological or psychiatric condition.

I have an injury or disease affecting my scalp.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Non-invasive brain stimulation with transcranial alternating current stimulation is applied during a memory interference intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in EEG-derived markers of brain activation and connectivity, and performance precision of a sensorimotor skill

24 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Inactive (sham) stimulation combined with behavioral intervention
• Transcranial alternating current stimulation (tACS) combined with behavioral intervention

Trial Overview The study tests if non-invasive brain stimulation (tACS) combined with behavioral tasks can change existing motor memories and aid new skill learning. Participants will also receive sham stimulation as a comparison while their brain activity is monitored using EEG.

How Is the Trial Designed?

Group I: Active non-invasive brain stimulation during behavioral memory interference Experimental Treatment 1 Intervention

Non-invasive brain stimulation with transcranial alternating current stimulation will be applied during a memory interference intervention.

Group II: Sham stimulation during behavioral memory interference Placebo Group 1 Intervention

Inactive (sham) stimulation will be applied during a memory interference intervention.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

In a study with 42 healthy participants, applying 0.75 Hz transcranial alternating current stimulation (tACS) during a thumb abduction motor training task led to significantly better retention of motor performance 24 hours later compared to sham stimulation.

While both active and sham stimulation groups showed immediate improvements in thumb abduction acceleration after training, only the active tACS group maintained these benefits over time, indicating that tACS can enhance the effectiveness of motor training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor training is improved by concurrent application of slow oscillating transcranial alternating current stimulation to motor cortex. Sale, MV., Kuzovina, A.[2022]

In a study with 20 adults, applying beta-band transcranial alternating current stimulation (tACS) immediately after practicing a motor skill significantly improved retention of that skill, with better performance observed 1 and 7 days later compared to a sham stimulation group.

The increase in beta-band corticomuscular coherence (CMC) correlated with improved motor performance, suggesting that enhancing oscillatory beta activity in the corticospinal system may play a key role in consolidating motor skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Alternating Current Stimulation of the Primary Motor Cortex after Skill Acquisition Improves Motor Memory Retention in Humans: A Double-Blinded Sham-Controlled Study. Yamaguchi, T., Svane, C., Forman, CR., et al.[2023]

In a study involving 18 healthy volunteers, sinusoidal transcranial alternating current stimulation (tACS) at 5 kHz for 10 minutes at 1 mA was found to be safe, as indicated by stable neuron-specific enolase (NSE) levels and no significant changes in EEG or MRI results.

The findings suggest that tACS does not cause structural or pathological changes in the brain, supporting its safety for use under the tested conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 5 kHz tACS. Chaieb, L., Antal, A., Pisoni, A., et al.[2022]

Transcranial alternating current stimulation (TACS) has demonstrated significant efficacy in improving symptoms of depression, with a standardized mean difference (SMD) of 1.14, indicating a strong positive effect compared to sham stimulation in patients.

TACS also showed a notable improvement in cognitive function among patients with psychiatric disorders, with an SMD of 0.60, suggesting it may enhance cognitive abilities in both patients and healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial alternating current stimulation and its effects on cognition and the treatment of psychiatric disorders: a systematic review and meta-analysis. Lee, ARYB., Yau, CE., Mai, AS., et al.[2022]

Noninvasive electrical brain stimulation (NEBS) using transcranial direct current stimulation (tDCS) and random noise stimulation (tRNS) significantly enhances motor skill learning in a tracing task, with effects observed during the training sessions rather than after.

The study found that unilateral tDCS led to immediate skill improvements, while tRNS produced more gradual enhancements, suggesting that these two stimulation methods may work through different mechanisms in facilitating motor learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of different electrical brain stimulation protocols on subcomponents of motor skill learning. Prichard, G., Weiller, C., Fritsch, B., et al.[2018]

In a study with 30 healthy participants, gamma transcranial alternating current stimulation (γ-tACS) applied over the primary motor cortex and cerebellum significantly improved motor learning retention compared to sham stimulation, indicating its potential to enhance the ability to maintain learned motor skills.

While γ-tACS showed benefits for retaining motor performance, it did not significantly affect the efficiency of motor learning or re-motor learning, suggesting that its primary effect may be on the retention aspect of motor skills rather than the initial learning process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on motor learning of transcranial alternating current stimulation applied over the primary motor cortex and cerebellar hemisphere. Miyaguchi, S., Inukai, Y., Matsumoto, Y., et al.[2020]

In a preliminary study with 28 participants, three common non-invasive brain stimulation (NIBS) methods (anodal tDCS, PAS25, and iTBS) were tested for their effects on motor learning, but no consistent differences in effectiveness were found among the groups.

The study highlighted the variability in responses to NIBS, suggesting that while these methods are promising, their effects on motor learning and cortical excitability may not be reliably reproducible, indicating a need for larger studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Comparison of Motor Learning Across Different Non-invasive Brain Stimulation Paradigms Shows No Consistent Modulations. Lopez-Alonso, V., Liew, SL., Fernández Del Olmo, M., et al.[2020]

The study tested a new cerebellar transcranial alternating current stimulation (tACS) protocol on 15 healthy participants but found that it did not enhance motor skill acquisition or retention during training.

Analysis revealed that factors like short intracortical inhibition during movement and baseline performance were key predictors of training success, suggesting that future interventions could be tailored based on these individual differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebellar transcranial alternating current stimulation in the gamma range applied during the acquisition of a novel motor skill. Wessel, MJ., Draaisma, LR., de Boer, AFW., et al.[2022]

Transcranial alternating current stimulation (tACS) significantly improves motor learning abilities in healthy individuals, based on a systematic review of 10 studies involving 270 participants.

While overall motor performance did not show significant improvement compared to sham stimulation, specific types of tACS, like gamma band and online tACS, did enhance motor performance, suggesting potential therapeutic applications for motor behavior improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial alternating current stimulation on motor performance and motor learning for healthy individuals: A systematic review and meta-analysis. Hu, K., Wan, R., Liu, Y., et al.[2022]

In a study involving 15 healthy adults, transcranial alternating current stimulation (tACS) at 5 Hz and 1 mA significantly improved working memory scores and increased brain activity in theta and delta frequency bands, indicating its potential to enhance cognitive function.

The study also established a closed-loop evaluation method that uses individual brain signals to optimize tACS protocols, suggesting that personalized stimulation durations can prevent overstimulation and improve effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness assessment of repetitive transcranial alternating current stimulation with concurrent EEG and fNIRS measurement. Yang, D., Ghafoor, U., Eggebrecht, AT., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9715745/

Effects of transcranial alternating current stimulation on ... The results showed that tACS effectively improves motor performance (gamma band and online mode) and motor learning in healthy individuals.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0166432815301200

The effect of transcranial alternating current stimulation ... In contrast, during 20 Hz tACS the initial learning success was retained despite interference. While motor-cortical tACS at 10 and 20 Hz ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11391832/

An overview of the effects and mechanisms of transcranial ... We summarize with the current state of the field, the effectiveness and variability in motor learning modulation, and novel mechanistic ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07913-4

Effectiveness and brain mechanism of multi-target transcranial ... Transcranial alternating current stimulation (tACS) has proven to be an effective treatment for improving cognition, a crucial factor in motor ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1094715923000090

Efficacy of Transcranial Alternating Current Stimulation in ... Our findings indicate that active tACS enhances WM performance in healthy individuals compared with sham.

6. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2020.00025/full

Age-Dependent Effect of Transcranial Alternating Current ... Aging increases the susceptibility to motor memory interference and reduces off-line gains in motor skill learning. Neurobiol. Aging 35 ...

7. ibroneuroscience.org ibroneuroscience.org/article/S0306-4522(19)30371-9/abstract

Transcranial Alternating Current Stimulation Has Frequency ... β-tACS delivered during training inhibits the acquisition of a motor learning task. •. γ-tACS slightly improved the acceleration of the practiced movement ...