Pediatric Transcranial Static Magnetic Field Stimulation to Improve Motor Learning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2019-06-01

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Right motor cortex (M1) tSMS

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

Group Type EXPERIMENTAL

Transcranial Static Magnetic Field Stimulation (tSMS)

Intervention Type 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

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

Group Type EXPERIMENTAL

Transcranial Static Magnetic Field Stimulation (tSMS)

Intervention Type 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 tSMS

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

Group Type SHAM_COMPARATOR

Sham Transcranial Static Magnetic Field Stimulation (tSMS)

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes