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

University of Calgary

Status and phase: Completed; Phase 1

Conditions: Healthy; Pediatrics

Treatments: Device: Sham Transcranial Static Magnetic Field Stimulation (tSMS); Device: Transcranial Static Magnetic Field Stimulation (tSMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03949712

REB18-0178

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

Right motor cortex (M1) tSMS

Experimental group

Description:

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

Treatment:

Device: Transcranial Static Magnetic Field Stimulation (tSMS)

Left motor cortex (M1) tSMS

Experimental group

Description:

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

Treatment:

Device: Transcranial Static Magnetic Field Stimulation (tSMS)

Sham tSMS

Sham Comparator group

Description:

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

Treatment:

Device: Sham Transcranial Static Magnetic Field Stimulation (tSMS)