Pediatric Transcranial Static Magnetic Field Stimulation to Improve Motor Learning

Healthy Clinical Trial

— PSTIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949712
• Other study ID #: REB18-0178
• Status: Completed
• Phase: Phase 1
• Start date: March 30, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

1. informed consent/assent

2. age between 8 and 18 years

3. right-handedness

4. normal development

5. absence of neuropsychiatric diagnoses or medications

Exclusion Criteria:

1. diagnosis of a neurological, psychiatric or developmental disorder

2. metal in mouth, implanted pacemakers, or other contraindications for brain stimulation

3. confirmed or potential pregnancy

Related Conditions & MeSH terms

• Healthy
• Pediatrics

Intervention

Device:
• Transcranial Static Magnetic Field Stimulation (tSMS)
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.
• Sham Transcranial Static Magnetic Field Stimulation (tSMS)
Sham tSMS consists of a small compact metal cylinder, identical in appearance to the real tSMS device.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Oliviero A, Carrasco-López MC, Campolo M, Perez-Borrego YA, Soto-León V, Gonzalez-Rosa JJ, Higuero AM, Strange BA, Abad-Rodriguez J, Foffani G. Safety Study of Transcranial Static Magnetic Field Stimulation (tSMS) of the Human Cortex. Brain Stimul. 2015 May-Jun;8(3):481-5. doi: 10.1016/j.brs.2014.12.002. Epub 2014 Dec 11. — View Citation

Oliviero A, Mordillo-Mateos L, Arias P, Panyavin I, Foffani G, Aguilar J. Transcranial static magnetic field stimulation of the human motor cortex. J Physiol. 2011 Oct 15;589(Pt 20):4949-58. doi: 10.1113/jphysiol.2011.211953. Epub 2011 Aug 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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