Brain Stimulation for Motor Learning in Children

Overseen By Shivakeshavan Ratnadurai-Giriharan, PhD

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Burke Medical Research Institute

Disqualifiers: Illness, disease

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

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 can improve motor learning in children. Researchers are testing a technique called Transcranial Random Noise Stimulation (tRNS) to determine if it enhances task learning in kids. Participants will practice either a grasping task or a reaching task, with or without brain stimulation. Children aged 10-17 who can follow simple instructions and do not have any illnesses qualify as good candidates for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking science.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that transcranial random noise stimulation is safe for children?

Research has shown that transcranial random noise stimulation (tRNS) is generally safe for adults. This non-invasive technique uses electrical currents to stimulate the brain. Studies have found it is increasingly used in both health and disease research.

However, limited information exists about its use in children, prompting researchers to exercise caution with younger participants. While adults typically tolerate it well, further studies are needed to confirm its safety for children.

For concerns, discussing potential risks with the study team is advisable. They can provide detailed information about the study's safety measures. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about using transcranial random noise stimulation (tRNS) for motor learning in children because it offers a non-invasive way to potentially enhance brain function without the need for medication. Unlike traditional therapies that might rely on physical exercises alone, tRNS employs gentle electrical noise to stimulate the brain, which could improve the speed and effectiveness of motor skill development. This novel technique could lead to faster improvements in tasks like grasping and reaching, making it a promising alternative to existing methods that typically take longer to show results.

What evidence suggests that transcranial random noise stimulation is effective for motor learning in children?

Research has shown that Transcranial Random Noise Stimulation (tRNS) can enhance brain activity related to motor skills. In this trial, participants will practice either a fine motor grasping task or a reaching task during tRNS or sham stimulation. One study found that tRNS significantly improved factors such as handling distractions, adjusting movements, and tolerating movement challenges during training. Another study showed that children and teenagers responded to tRNS similarly to adults, increasing activity in the brain area that controls movement. This suggests that tRNS could aid in learning and performing tasks involving movement. Early evidence indicates it could be a promising tool for improving motor skills. ^{5 6 7 8 9}

Who Is on the Research Team?

Kathleen Friel, PhD

Principal Investigator

Burke Neurological Institute

Are You a Good Fit for This Trial?

This trial is for typically developing kids aged 10-17 who can follow instructions and give informed consent. It's not suitable for those with any illness or disease that could interfere with the study.

Inclusion Criteria

I am between 10 and 17 years old.

Provides informed consent

I can follow two-step instructions.

Exclusion Criteria

I have a diagnosed illness or disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive transcranial random noise stimulation or sham stimulation while completing motor tasks

1 day

1 visit (in-person)

Follow-up

Participants are monitored for motor learning effectiveness immediately after treatment

Immediately after treatment

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Random Noise Stimulation

Trial Overview The study tests how non-invasive brain stimulation, specifically transcranial random noise stimulation, affects learning motor tasks compared to a sham (fake) stimulation in adolescents.

How Is the Trial Designed?

Group I: Reach Task Experimental Treatment 2 Interventions

Participants will practice a reaching task for 20 min during tRNS or sham stimulation.

Group II: Grasp Task Experimental Treatment 2 Interventions

Participants will practice a fine motor grasping task for 20 min during tRNS or sham stimulation.

Who Is Running the Clinical Trial?

Burke Medical Research Institute

Lead Sponsor

Trials

24

Recruited

1,500+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) at 1mA for 10 minutes is well tolerated in children and adolescents aged 11-16, with a low rate of adverse events and no serious complications reported.

The study found no signs of harmful effects, such as epileptiform activity, in EEG recordings, suggesting that tDCS is a safe method for modulating brain activity in the developing brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten minutes of 1 mA transcranial direct current stimulation was well tolerated by children and adolescents: Self-reports and resting state EEG analysis. Moliadze, V., Andreas, S., Lyzhko, E., et al.[2015]

In a study involving 429 pediatric patients undergoing transcranial magnetic stimulation (TMS) for motor and language mapping, most adverse events were benign, with seizures occurring in 5.8% of sessions but not conclusively linked to TMS.

TMS was safely performed in patients with cranial metal, and useful mapping results were achieved in nearly all cases, indicating that TMS is a safe option for functional mapping in pediatric patients with epilepsy or brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. Braden, AA., Weatherspoon, SE., Boardman, T., et al.[2022]

In a study involving 23 unmedicated children with ADHD, high-frequency transcranial random noise stimulation (tRNS) combined with cognitive training led to significant reductions in ADHD symptoms, as reported by parents, after 2 weeks of treatment.

The tRNS treatment also resulted in changes in brain activity, specifically a reduction in beta bandwidth and a more favorable cortical excitation/inhibition balance, suggesting potential cognitive improvements, although no significant differences were found in executive functions or adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial random noise stimulation combined with cognitive training for treating ADHD: a randomized, sham-controlled clinical trial. Dakwar-Kawar, O., Mairon, N., Hochman, S., et al.[2023]

In a study involving human subjects trained over 4 consecutive days, transcranial random noise stimulation (tRNS) applied to the parietal region significantly improved attention and increased connectivity in the dorsal and ventral attention network (DVAN).

The improvement in attention was directly correlated with the increased connectivity, suggesting that tRNS could enhance cognitive function in healthy individuals and aid recovery in those with neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention network modulation via tRNS correlates with attention gain. Contò, F., Edwards, G., Tyler, S., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11790889/

The effect of transcranial random noise stimulation on the ... Statistical analyses showed that training with tRNS has a significant effect on noise cost, co-variation, and movement tolerance (p ≤ 0.05). In ...

2. withpower.com withpower.com/trial/early-phase-1-children-8-2024-6d050

Brain Stimulation for Motor Learning in Children Research shows that Transcranial Random Noise Stimulation (tRNS) can increase brain activity related to motor function and improve motor skills in healthy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7443018/

The Effects of 1 mA tACS and tRNS on Children/Adolescents ... In this study, children and adolescents responded to 1 mA tRNS and tACS comparably to adults regarding the modulation of motor cortex excitability.

4. nature.com nature.com/articles/s41598-025-85682-z

The effect of transcranial random noise stimulation (tRNS) ... Previous research has demonstrated that tRNS can enhance performance in tasks requiring visual discrimination, attention, and WM. Compared to ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1577899/full

Comparing the effect of transcranial random noise ... A recent meta-analysis regarding tDCS effects in healthy participants showed an improvement in UL motor performance, as demonstrated in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7916366/

Systematic Review on the Safety and Tolerability of ... Without adequate evidence for tDCS safety in youth, researchers and clinicians will remain aptly cautious to use tDCS in children. The current ...

7. nature.com nature.com/articles/s41598-025-88256-1

Examining tolerability, safety, and blinding in 1032 ... The present study first extensively evaluated the tolerability, safety, and blinding of transcranial direct current stimulation (tDCS) and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10394047/

Transcranial random noise stimulation combined with ... Systematic review on the safety and tolerability of transcranial direct current stimulation in children and adolescents. Brain Sci. 2021 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0149763422001919

Using noise for the better: The effects of transcranial ... tRNS is a non-invasive electrical brain stimulation method that is increasingly employed in studies of human brain function and behavior, in health and disease.