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

August 1, 2019 updated by: Adam Kirton, University of Calgary

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline to immediately following the tSMS intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in left-hand Purdue Pegboard Test (PPT) score from baseline to after the tSMS intervention
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)
Change from baseline to immediately following the tSMS intervention
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)
Change from baseline to immediately following the tSMS intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Adam Kirton, MD, MSc, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • REB18-0178

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Transcranial Static Magnetic Field Stimulation (tSMS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe