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Pediatric Transcranial Static Magnetic Field Stimulation to Improve Motor Learning (PSTIM)

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ClinicalTrials.gov Identifier: NCT03949712
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Adam Kirton, 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.

Condition or disease Intervention/treatment Phase
Healthy Pediatrics Device: Transcranial Static Magnetic Field Stimulation (tSMS) Device: Sham Transcranial Static Magnetic Field Stimulation (tSMS) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will receive all 3 treatment arms (Right M1 tSMS, Left M1 tSMS, sham tSMS) in a randomized order.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Transcranial Static Magnetic Field Stimulation (tSMS) on Motor Learning and Cortical Neurophysiology in the Developing Brain
Actual Study Start Date : March 30, 2018
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

Arm Intervention/treatment
Experimental: Right motor cortex (M1) tSMS
tSMS will be applied to the right motor cortex for 30 minutes.
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.

Experimental: Left motor cortex (M1) tSMS
tSMS will be applied to the left motor cortex for 30 minutes.
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 Comparator: Sham tSMS
Sham tSMS will be applied to the left or right motor cortex (randomized) for 30 minutes.
Device: Sham Transcranial Static Magnetic Field Stimulation (tSMS)
Sham tSMS consists of a small compact metal cylinder, identical in appearance to the real tSMS device.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949712


Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Adam Kirton, MD, MSc University of Calgary

Publications:
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Responsible Party: Adam Kirton, Professor of Pediatrics, Radiology, and Clinical Neurosciences; Director of Calgary Pediatric Stroke Program and N3; Pediatric Neurologist, University of Calgary
ClinicalTrials.gov Identifier: NCT03949712     History of Changes
Other Study ID Numbers: REB18-0178
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No