Pediatric Transcranial Static Magnetic Field Stimulation to Improve Motor Learning

Study Overview
=================
Brief Summary
-----------------
Non-invasive brain stimulation (NIBS) is a safe, painless way to improve brain function. It is used for many conditions, including to help children with disabilities. However, it can be challenging to apply NIBS in very young children and infants. A new, simple form of NIBS called transcranial static magnetic field stimulation (tSMS) is a promising tool for early brain stimulation. tSMS in adults has been shown to be safe, tolerable and have the desired effects on brain activity when applied to the motor cortex of the brain. However, how tSMS affects on motor function is not understood. This research will use tSMS to target the motor cortex which is responsible for voluntary movement. The study will determine if tSMS can improve motor learning in healthy children. It is hypothesized that application of tSMS on the right motor cortex will decrease excitability of the motor cortex and will lead to improved motor learning in the right hand. tSMS has the potential to become a safe, inexpensive, home-based way to enhance personalized rehabilitation for disabled children.

Official Title
-----------------
Effects of Transcranial Static Magnetic Field Stimulation (tSMS) on Motor Learning and Cortical Neurophysiology in the Developing Brain

Conditions
-----------------
Healthy, Pediatrics

Intervention / Treatment
-----------------
* Device: Transcranial Static Magnetic Field Stimulation (tSMS)
* Device: Sham Transcranial Static Magnetic Field Stimulation (tSMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent/assent age between 8 and 18 years right-handedness normal development absence of neuropsychiatric diagnoses or medications Exclusion Criteria: diagnosis of a neurological, psychiatric or developmental disorder metal in mouth, implanted pacemakers, or other contraindications for brain stimulation confirmed or potential pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will receive all 3 treatment arms (Right M1 tSMS, Left M1 tSMS, sham tSMS) in a randomized order.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right motor cortex (M1) tSMS<br>tSMS will be applied to the right motor cortex for 30 minutes. | Device: Transcranial Static Magnetic Field Stimulation (tSMS)<br>* tSMS consists of a small compact cylindrical neodynium magnet (S-45-30-N, Supermagnete) with an estimated strength of up to 0.5 Tesla and a size of 30 mm x 45 mm.<br>|
| Experimental: Left motor cortex (M1) tSMS<br>tSMS will be applied to the left motor cortex for 30 minutes. | Device: Transcranial Static Magnetic Field Stimulation (tSMS)<br>* tSMS consists of a small compact cylindrical neodynium magnet (S-45-30-N, Supermagnete) with an estimated strength of up to 0.5 Tesla and a size of 30 mm x 45 mm.<br>|
| Sham Comparator: Sham tSMS<br>Sham tSMS will be applied to the left or right motor cortex (randomized) for 30 minutes. | Device: Sham Transcranial Static Magnetic Field Stimulation (tSMS)<br>* Sham tSMS consists of a small compact metal cylinder, identical in appearance to the real tSMS device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in amplitude of motor evoked potentials (MEPs) | Baseline data will be collected through application of single Transcranial Magnetic Stimulation (TMS) pulses used to assess cortical excitability within one hemisphere. For this, two stimulators (Magstim and Bistim) are connected by an adaptor. A single flat iron Magnstim TMS coil is held over the right hotspot, and pairs of pulses is delivered from this coil. 10 test pulses at an intensity of 120% of resting motor threshold (RMT) are applied. These pulses will be randomized with other paired-pulses to collect other outcome measures (described in the secondary outcome measures section) | Change from baseline to immediately following the tSMS intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left-hand Purdue Pegboard Test (PPT) score. | A baseline trial will be performed. During the intervention, participants will perform 25 repetitions. A post trail will be performed following the neurophysiology measurements after the tSMS intervention. An increase in score on the PPT would be indicative of improved performance on the task. | Change in left-hand Purdue Pegboard Test (PPT) score from baseline to after the tSMS intervention | 
| Change in short-interval intracortical inhibition (SICI) | Baseline data will be collected through application of paired TMS pulses used to assess cortical excitability within one hemisphere. For this, two stimulators (Magstim and Bistim) are connected by an adaptor. A single flat iron Magnstim TMS coil is held over the right hotspot, and pairs of pulses is delivered from this coil. A conditioning pulse is applied to the left hemisphere at an intensity of 80% RMT, followed by a test pulse over the right hemisphere at an intensity of 120% RMT. 10 pairs of pulses are applied with an interstimulus interval of 2 ms to test for SICI These pulses will be randomized with other paired-pulses and single pulses to collect other outcome measures (described in the primary and secondary outcome measures section) | Change from baseline to immediately following the tSMS intervention | 
| Change in intracortical facilitation (ICF) | Baseline data will be collected through application of paired TMS pulses used to assess cortical excitability within one hemisphere. For this, two stimulators (Magstim and Bistim) are connected by an adaptor. A single flat iron Magnstim TMS coil is held over the right hotspot, and pairs of pulses is delivered from this coil. A conditioning pulse is applied to the left hemisphere at an intensity of 80% RMT, followed by a test pulse over the right hemisphere at an intensity of 120% RMT. 10 pairs of pulses are applied with an interstimulus interval of 10 ms to test for ICF. These pulses will be randomized with other paired-pulses and single pulses to collect other outcome measures (described in the primary and secondary outcome measures section) | Change from baseline to immediately following the tSMS intervention |