Pediatric Transcranial Static Magnetic Field Stimulation to Improve Motor Learning

Phase 1

Completed

• Conditions: Healthy; Pediatrics
• Interventions: Device: Transcranial Static Magnetic Field Stimulation (tSMS); Device: Sham Transcranial Static Magnetic Field Stimulation (tSMS)

• Registration Number: NCT03949712
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-03-30
• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Right motor cortex (M1) tSMS	Transcranial Static Magnetic Field Stimulation (tSMS)	tSMS will be applied to the right motor cortex for 30 minutes.
Left motor cortex (M1) tSMS	Transcranial Static Magnetic Field Stimulation (tSMS)	tSMS will be applied to the left motor cortex for 30 minutes.
Sham tSMS	Sham Transcranial Static Magnetic Field Stimulation (tSMS)	Sham tSMS will be applied to the left or right motor cortex (randomized) for 30 minutes.

Primary Outcome Measures

Name	Time	Method
Change in amplitude of motor evoked potentials (MEPs)	Change from baseline to immediately following the tSMS intervention	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)

Secondary Outcome Measures

Name	Time	Method
Change in left-hand Purdue Pegboard Test (PPT) score.	Change in left-hand Purdue Pegboard Test (PPT) score from baseline to after the tSMS intervention	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 short-interval intracortical inhibition (SICI)	Change from baseline to immediately following the tSMS intervention	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 in intracortical facilitation (ICF)	Change from baseline to immediately following the tSMS intervention	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)

Trial Locations

Locations (1)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada