Pediatric Transcranial Static Magnetic Field Stimulation to Improve Motor Learning

NCT03949712 | Completed Phase 1

• 1 other identifier: REB18-0178
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Change in short-interval intracortical inhibition (SICI)

  Change from baseline to immediately following the tSMS intervention

• Change in intracortical facilitation (ICF)

  Change from baseline to immediately following the tSMS intervention

Study Arms (3)

Right motor cortex (M1) tSMS

EXPERIMENTAL

tSMS will be applied to the right motor cortex for 30 minutes.

Device: Transcranial Static Magnetic Field Stimulation (tSMS)

Left motor cortex (M1) tSMS

EXPERIMENTAL

tSMS will be applied to the left motor cortex for 30 minutes.

Device: Transcranial Static Magnetic Field Stimulation (tSMS)

Sham tSMS

SHAM COMPARATOR

Sham tSMS will be applied to the left or right motor cortex (randomized) for 30 minutes.

Device: Sham Transcranial Static Magnetic Field Stimulation (tSMS)

Interventions

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.

Left motor cortex (M1) tSMS; Right motor cortex (M1) tSMS

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.

Sham tSMS

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• informed consent/assent
• age between 8 and 18 years
• right-handedness
• normal development
• absence of neuropsychiatric diagnoses or medications

You may not qualify if:

• diagnosis of a neurological, psychiatric or developmental disorder
• metal in mouth, implanted pacemakers, or other contraindications for brain stimulation
• confirmed or potential pregnancy

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (2)

• 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.

  PMID: 21807616 BACKGROUND

• Oliviero A, Carrasco-Lopez MC, Campolo M, Perez-Borrego YA, Soto-Leon 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.

  PMID: 25595064 BACKGROUND

Study Officials

• Adam Kirton, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Radiology, and Clinical Neurosciences; Director of Calgary Pediatric Stroke Program and N3; Pediatric Neurologist

Model Details: Participants will receive all 3 treatment arms (Right M1 tSMS, Left M1 tSMS, sham tSMS) in a randomized order.

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: May 14, 2019
• Study Start: March 30, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

CA (1)