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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injury focused on measuring transcranial magnetic stimulation, spinal cord injury, motor cortex, somatosensory cortex

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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:

None.

Sites / Locations

  • McMaster Unviersity

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

iTBS to primary motor cortex

iTBS to primary somatosensory cortex

Sham iTBS to primary motor cortex

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 22, 2015
Last Updated
August 14, 2018
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT02351921
Brief Title
Repetitive Transcranial Magnetic Stimulation in Individuals With Spinal Cord Injury: A Pilot Study
Official Title
Repetitive Transcranial Magnetic Stimulation in Individuals With Spinal Cord Injury: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
transcranial magnetic stimulation, spinal cord injury, motor cortex, somatosensory cortex

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iTBS to primary motor cortex
Arm Type
Experimental
Arm Description
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.
Arm Title
iTBS to primary somatosensory cortex
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham iTBS to primary motor cortex
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Other Intervention Name(s)
Repetitive TMS, intermittent theta-burst stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measuring changes in motor evoked potential
Description
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 Outcome Measure Information:
Title
Measuring changes in muscle force production
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: None.
Facility Information:
Facility Name
McMaster Unviersity
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada

12. IPD Sharing Statement

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

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