The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).
At least 18 years old and no older than 70 years old at the time of enrollment.
Able-bodied subjects
Traumatic spinal cord injury
Upper limb target: neurological level at or above Thoracic 1 level, Abbreviated Injury Scale (AIS) B, C or D impairment grade, primary non-ambulatory;
Has traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.
Has severe spasticity that could prevent the study protocol as determined by the investigator.
Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
Has contraindications for transcutaneous stimulation using FES or TSCS such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease.
Parallel
Intermittent theta burst stimulation (iTBS)
Other interventioniTBS is a magnetic stimulation applied using a magnetic coil that is placed on top of the participants head to activate the brain. It consists of three very rapid bursts of electrical pulses at a frequency of 50 Hz (per burst) delivered at a rate of 5 per second for 2 seconds (10 bursts). The burst of pulses will be repeated every 10 seconds for a total duration of about 3 minutes. The stimulation will be applied to activate the brain regions that control upper limb, lower limb or trunk muscles. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours.
Functional electrical stimulation (FES)
Other interventionFES is applied using electrodes that stick to the skin over the muscles or nerves. It will will be applied using an electrical stimulator to produce movements of the hand, leg or the trunk. The stimulation intensity will be determined by gradually increasing strength from 20-100 hertz (hz) until the right amount of movement is obtained. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours.
Transcutaneous spinal cord stimulation (TSCS)
Other interventionTSCS is applied using electrodes that stick to the skin over the spinal cord to activate spinal cord. Mild electrical stimulation will be applied to make sure the nerves on the back are activated (switched on). Different stimulation intensities (strength) will be tested at different frequencies (pulses per second) to determine the best setting for activating the nerves on the back. The stimulus current strength will be adjusted between 0-250 milliamperes (mA) and will remain within the self-reported tolerance limit of each participant. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours.
Sham Intermittent theta burst stimulation (iTBS)
Other interventionSubjects will be fitted with a magnetic coil that is placed on top of the head that does not deliver any stimulation to the brain. Each subject is expected to participate longitudinally at least 9 times over 2 months.Each visit will take approximately 2-3 hours.
Change in nine-hole peg test
The Nine-Hole Peg Test assesses hand and finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the activity, recorded in seconds.
Change in foot tapping test (FTT)
FTT assesses motor neuron function and mobility. Participants are seated with the foot on the floor and are asked to tap their foot on the ground as rapidly as possible for 10 seconds while keeping the heel on the ground. The number of taps are counted during the 10 seconds.
Change in Function in Sitting Test for people with SCI (FIST-SCI)
FIST-SCI is a clinical test that will be used to test seated balance. FIST-SCI consists of 14 functional, everyday activities as test items. The items are scored on a 5 point ordinal scale ranging from 0 to 4, with 0 representing the lowest ability and 4 representing normal ability.
Change in Motor Evoked Potential (MEP)
MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV).
Click on the lead sponsor to view all of their trials.
