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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Transcranial Random Noise 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 individuals. Additionally, tRNS has been found to enhance cognitive abilities and attention in children with ADHD, suggesting its potential to aid in motor learning as well. ^{1 2 3 4 5}

Is transcranial random noise stimulation (tRNS) safe for children?

Research shows that transcranial random noise stimulation (tRNS) is generally well tolerated in children and adolescents, with low rates of minor side effects and no serious adverse events reported. Studies indicate that both tRNS and similar techniques like transcranial direct current stimulation (tDCS) are safe for use in young people. ^{3 4 5 6 7}

How does transcranial random noise stimulation (tRNS) differ from other treatments for motor learning in children?

Transcranial random noise stimulation (tRNS) is unique because it uses a non-invasive electrical current applied to the scalp to enhance brain activity and improve motor learning. Unlike traditional therapies, tRNS can modulate brain excitability and has been shown to improve cognitive and motor functions in various conditions, making it a novel approach for enhancing motor learning in children. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this study is to compare motor learning rates on two different tasks, when combined with non-invasive brain stimulation.

Research Team

Kathleen Friel, PhD

Principal Investigator

Burke Neurological Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Transcranial random noise stimulation combined with cognitive training for treating ADHD: a randomized, sham-controlled clinical trial. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of transcranial random noise stimulation timing on corticospinal excitability and motor function. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Attention network modulation via tRNS correlates with attention gain. [2021]

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

High-frequency TRNS reduces BOLD activity during visuomotor learning. [2021]

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

The Effects of 1 mA tACS and tRNS on Children/Adolescents and Adults: Investigating Age and Sensitivity to Sham Stimulation. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. [2022]

7. United States 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. [2015]