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HealthyPhase 1PSTIMNCT03949712

Pediatric Transcranial Static Magnetic Field Stimulation to Improve Motor Learning

A Phase 1 study testing Transcranial Static Magnetic Field Stimulation (tSMS) in people with Healthy and Pediatrics, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Pediatrics
What is being tested?
Transcranial Static Magnetic Field Stimulation (tSMS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteCanada
Study dates
30 Mar 2018to 1 Jun 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

Other trials in Canada

About this study

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

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
Being tested
Transcranial Static Magnetic Field Stimulation (tSMS), Sham Transcranial Static Magnetic Field Stimulation (tSMS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03949712
Study groupRoleWhat they receive
Right motor cortex (M1) tSMSExperimentaltSMS will be applied to the right motor cortex for 30 minutes.
Receives: Device: Transcranial Static Magnetic Field Stimulation (tSMS)
Left motor cortex (M1) tSMSExperimentaltSMS will be applied to the left motor cortex for 30 minutes.
Receives: Device: Transcranial Static Magnetic Field Stimulation (tSMS)
Sham tSMSSham comparatorSham tSMS will be applied to the left or right motor cortex (randomized) for 30 minutes.
Receives: Device: Sham Transcranial Static Magnetic Field Stimulation (tSMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Change from baseline to immediately following the tSMS intervention

Secondary outcomes (3)

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

    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.

    Measured: Change in left-hand Purdue Pegboard Test (PPT) score from baseline to after the tSMS intervention

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

    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)

    Measured: Change from baseline to immediately following the tSMS intervention

  3. Change in intracortical facilitation (ICF)

    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)

    Measured: Change from baseline to immediately following the tSMS intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2019
  2. Study start30 Mar 2018
  3. Primary completion1 Jun 2019
  4. Study completion1 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Participants will receive all 3 treatment arms (Right M1 tSMS, Left M1 tSMS, sham tSMS) in a randomized order.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03949712
Sponsor's protocol ID
REB18-0178
Acronym
PSTIM
Status last verified
Aug 2019
First submitted
18 Apr 2019
Last updated
5 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 21807616

  • 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.

    PubMed 25595064

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Transcranial Static Magnetic Field Stimulation (tSMS) in people with Healthy and Pediatrics, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in amplitude of motor evoked potentials (MEPs) (time frame: Change from baseline to immediately following the tSMS intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03949712, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.

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