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Completed

NCT Number: NCT03949712

Pediatric Transcranial Static Magnetic Field Stimulation to Improve Motor Learning

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.

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Key information

Conditions

Healthy Pediatrics

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial static magnetic field stimulation (tSMS)

Device

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)

Device

Sham tSMS consists of a small compact metal cylinder, identical in appearance to the real tSMS device.

Primary outcomes

  1. Change in amplitude of motor evoked potentials (MEPs)

    Time frame: 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 outcomes

  1. Change in left-hand Purdue Pegboard Test (PPT) score.

    Time frame: 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.

  2. Change in short-interval intracortical inhibition (SICI)

    Time frame: 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)

  3. Change in intracortical facilitation (ICF)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Acronym: PSTIM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 14, 2019
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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