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CompletedNCT02351921Updated Aug 16, 2018

Repetitive Transcranial Magnetic Stimulation in Individuals With Spinal Cord Injury: A Pilot Study

An interventional study of Transcranial magnetic stimulation in Spinal Cord Injury, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-16.

Sponsored by McMaster University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study will investigate how repetitive transcranial magnetic stimulation delivered as a protocol called 'continuous theta-burst stimulation (cTBS)' alters motor output and force control to a muscle in the forearm and touch perception in individuals with chronic, incomplete spinal cord injury. CTBS is a non-invasive technique that involved repetitive delivery of transcranial magnetic stimulation at a frequency of 30 Hz over the arm representation in the primary motor or sensory cortex. The purpose of this study is to determine whether cTBS is an effective intervention to increase motor output to a muscle and increase force control of that muscle and also improve the sense of touch.

Read the detailed description

Experience and injury-induced neuroplasticity occur in sensory and motor pathways and cortices. Sensory and motor cortices are interconnected and collectively allow for the execution of fine, skilled hand control. Of particular interest is the role of somatosensory cortex in modulating the neural activity within primary motor cortex and ultimately influencing the control of hand movement. For somatosensory cortex to be effective in guiding hand movement it must receive an uninterrupted stream of somatosensory afferent input from skin, muscle and tendons that are active during hand movement. Damage to afferent input pathways compromise the integrity of necessary somatosensory input and contribute to impaired motor control of the hand. Following an incomplete spinal cord injury (SCI), damage to the somatosensory and motor pathways are widespread thereby compromise the integrity of afferent input that reaches somatosensory cortex [1,2]. Reducing the afferent input to somatosensory cortex leads to local changes in the concentration of GABA and promotes sensorimotor reorganization [3].

Transcranial magnetic stimulation has been used in SCI to measure residual corticospinal function [4], determine changes in the excitability of neural circuitry within the primary motor cortex [5] and induce short-lasting changes in the excitability of spinal motor neurons [6]. To date, TMS research in SCI has primarily focused on lower limb function, likely fueled by the desire to promote functional recovery of locomotion and balance control. However, one of the main determinants in promoting independent living is the ability to feed and groom oneself, relying primarily on the control of the upper limb and the dexterous use of the hand. The proposed research will investigate the ability to increase motor output to muscle of the hand and upper limb through inducing short-lasting changes within SI and investigate whether this has functional implication in force production, motor control and touch perception.

TMS may be delivered as a single, pair or a train of repetitive pulses over a particular body representation within the primary motor cortex or primary somatosensory cortex. One type of repetitive TMS is called continuous theta-burst stimulation (cTBS). The present study will deliver cTBS over the primary motor and primary somatosensory cortices in individual with chronic SCI. Measurements will be made before and following the cTBS protocol. These measures include 1) the amplitude of the motor evoked potential (MEP) that is evoked by single pulse TMS and measured in the forearm muscle, 2) force production whereby participants will be asked to perform a grip strength task where maximum force production will be measured and ability to dynamically control force production will be assessed, and 3) touch sensation whereby participants will partake in a temporal order judgment psychophysical task such that they must identify which fingertip received the tactile stimulus.

02

Conditions studied

  • Spinal Cord Injury

Keywords

  • transcranial magnetic stimulation
  • spinal cord injury
  • motor cortex
  • somatosensory cortex
03

In context

Spinal Cord Injuries

1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.

This study's enrollment of 8 is below the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Individuals with chronic incomplete SCI (American spinal injury association scale B, C or D) at or below levels C4, C5, C6, C7 and T1 with injury occurring > 1 year prior will be recruited.

Exclusion criteria

Exclusion Criteria:

None.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    iTBS to primary motor cortex

    Intermittent TBS will be delivered using the 30 Hz, 600 pulse protocol targeting the primary motor cortex of the left hemisphere. The iTBS TMS coil will be placed over the motor hotspot for the representation of the flexor carpi radialis muscle.

    Device: Transcranial magnetic stimulation

  • Experimental
    iTBS to primary somatosensory cortex

    Intermittent TBS will be delivered using the 30 Hz, 600 pulse protocol targeting the primary motor cortex of the left hemisphere. The iTBS TMS coil will be placed over the primary somatosensory cortex located 2cm posterior to the motor hotspot for the representation of the flexor carpi radialis muscle.

    Device: Transcranial magnetic stimulation

  • Sham comparator
    Sham iTBS to primary motor cortex

    Sham iTBS will be delivered using the 30 Hz, 600 pulse protocol targeting the primary motor cortex of the left hemisphere. The iTBS sham coil will be placed over the motor hotspot for the representation of the flexor carpi radialis muscle.

    Device: Transcranial magnetic stimulation

Interventions

  • DeviceTranscranial magnetic stimulation

    Intermittent theta-burst stimulation is a form of repetitive Transcranial magnetic stimulation. ITBS is a non-invasive, non-painful procedure being used worldwide to study brain function and promote short-term changes (\~1 hour) in neural activity in the brain. The delivery of cTBS requires \~ 40 seconds in total.

    Also known as: Repetitive TMS, intermittent theta-burst stimulation

06

What researchers measure

Primary outcomes

  1. Measuring changes in motor evoked potential

    The motor evoked potential is the response obtained in the forearm muscle that follows single pulse TMS. The amplitude of this measure is an indicator of the corticospinal excitability. This measure will be obtained at baseline and 20 minutes following the intervention.

    Time frame: Immediatately before intervention, and at 20 minutes following intervention

Secondary outcomes

  1. Measuring changes in muscle force production

    Participants will be asked to squeeze a hand grip that has been fitted to a force transducer/load cell. They will be asked to maximally squeeze until a plateau is seen in the voltage output. Participants will be asked to squeeze a hand grip that has been fitted to a force transducer/load cell. They will adjust the pressure applied to the hand grip in attempt to match a random sinusoid curve that has been generated. This trial will last for 10 seconds and will be based on the maximum force generated in the previous task.

    Time frame: Immediatately before intervention, and at 25 minutes following intervention

07

Study locations

1 site
  • McMaster Unviersity
    Hamilton, Ontario L8S 4K1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02351921
Responsible party
Sponsor
First posted
Jan 30, 2015
Start date
Feb 2015
Primary completion
Jan 2017
Completion
Feb 2017
Last update
Aug 16, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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