Spinal Cord InjuryNCT02351921
Repetitive Transcranial Magnetic Stimulation in Individuals With Spinal Cord Injury: A Pilot Study
A study testing Transcranial magnetic stimulation in people with Spinal Cord Injury, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Feb 2017
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinal Cord Injury
- Being tested
- Transcranial magnetic stimulation
- Keywords
- transcranial magnetic stimulation, spinal cord injury, motor cortex, somatosensory cortex
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
Also called Repetitive TMS, intermittent theta-burst 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.
| Study group | Role | What they receive |
|---|---|---|
| iTBS to primary motor cortex | Experimental | 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. Receives: Device: Transcranial magnetic stimulation |
| iTBS to primary somatosensory cortex | Experimental | 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. Receives: Device: Transcranial magnetic stimulation |
| Sham iTBS to primary motor cortex | Sham comparator | 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. Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediatately before intervention, and at 25 minutes following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351921
- Sponsor's protocol ID
- 23423432
- Status last verified
- Aug 2018
- First submitted
- 22 Jan 2015
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation in Individuals With Spinal Cord Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT02351921
- Acronym / sponsor ID
- 23423432
- Conditions
- Spinal Cord Injury
- Keywords
- transcranial magnetic stimulation, spinal cord injury, motor cortex, somatosensory cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iTBS to primary motor cortex | Experimental | Device: Transcranial magnetic stimulationIntermittent 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. |
| iTBS to primary somatosensory cortex | Experimental | Device: Transcranial magnetic stimulationIntermittent 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 to primary motor cortex | Sham comparator | Device: Transcranial magnetic stimulationSham 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationAlso: Repetitive TMS, intermittent theta-burst stimulationIntermittent 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. | Device | Sham iTBS to primary motor cortex, iTBS to primary motor cortex, iTBS to primary somatosensory cortex |
Primary outcome
Measuring changes in motor evoked potential
Time frame: Immediatately before intervention, and at 20 minutes following intervention
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.
1 secondary outcome
Measuring changes in muscle force production
Time frame: Immediatately before intervention, and at 25 minutes following intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Spinal Cord Injury, run by McMaster University 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 1 inclusion and 1 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 16 Aug 2018. 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.
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?
Measuring changes in motor evoked potential (time frame: Immediatately before intervention, and at 20 minutes following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2018.