Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upper-limb (arms) target group | Experimental | Quadriplegic individuals with SCI who are primary non-ambulatory (walking) will be in this group for up to 2 months. |
|
| Lower-limb (legs) target group | Experimental | Quadriplegic or paraplegic individuals with SCI primary who can walk will be in this group for up to 2 months. |
|
| Trunk (torso) target group | Experimental | Quadriplegic or paraplegic individuals with SCI who are primary wheelchair users will be in this group for up to 2 months. |
|
| Able-bodied target group | Active Comparator | Individuals with no spinal cord injury will be in this group for up to 2 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent theta burst stimulation (iTBS) | Other | iTBS 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, up to 2 months |
| 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. | baseline, up to 2 months |
| 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. | baseline, up to 2 months |
| 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). | baseline, up to 2 months |
Not provided
Not provided
Inclusion Criteria:
Male or Female subjects
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;
Spinal cord injury sustained more than 6 months prior to study.
Movement/excitability/etc:
Able to commit to intervention and assessment sessions over a maximum duration of 2 months.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deena Cilien, DPT | Contact | (305) 243-9301 | dcilien@med.miami.edu | |
| Matija Milosevic, PhD | Contact | (305) 243-3572 | mmilosevic@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matija Milosevic, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Functional electrical stimulation (FES) | Other | FES 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 | TSCS 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 | Subjects 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. |
|
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
Not provided
Not provided