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This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed.
Purpose of this project
Spinal cord stimulation has the potential to improve motor function recovery after spinal cord injury. Commonly used approaches include low-intensity, direct current (DC) stimulation applied across multiple segments, electrical transcutaneous (ETC) stimulation, and magnetic transcutaneous stimulation (MTC).
Objective: to evaluate and compare the voluntary and reflexive motor performance in the same subjects, including people with and without spinal cord injury, after non-invasive spinal cord stimulation interventions. Comparing two different interventions applied in different experimental sessions and the respective sham stimulation is the goal of this study.
corticospinal and spinal motor pathways in paraplegics and in non-injured humans will be tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal cord stimulation | Experimental | Spinal cord stimulation will be administered to participants for 15 min. |
|
| Shamspinal cord stimulation | Sham Comparator | Sham spinal cord stimulation will be administered to participants for 15 min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal stimulation-DCS | Device | transcutaneous spinal stimulation by direct current stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor response | H-reflex input output curve | Immediately after stimulation (within 1-15 min) |
| Motor evoked potentials | MEP input-output curve | Immediately after stimulation (within 1-15 min) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Measured (in arm) with inflatable cuff-automated, standard machine. | During the procedure/stimulation and up to 15 min after stimulation. |
| Perception of discomfort due to stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katinka Stecina, PhD | Contact | 204 789 3761 | katinka.stecina@umanitoba.ca | |
| Kristine Cowley, PhD | Contact | 2047893305 | kristine.cowley@umanitoba.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Enrolling by invitation | Winnipeg | Manitoba | R3E 0J9 | Canada | |
Upon request, we will consider making anonymized data available for analysis by other researchers
After study completion (May 2022) for one year.
Upon request
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Semi-blinded, randomized block entry design, crossover intervention study.
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The participant will be connected to the stimulation device(s) but will not know if it has been turned on during each trial. In addition, the person analyzing the outcome data will not be aware of the stimulation status of the participant.
| spinal stimulation-sham DCS | Other | sham transcutaneous spinal stimulation by direct current stimulation |
|
| spinal stimulation-EPS | Other | transcutaneous spinal stimulation by electrical pulsed stimulation |
|
| sham spinal stimulation-EPS | Other | sham transcutaneous spinal stimulation by electrical pulsed stimulation |
|
self-reporting on a scale ( the higher, the more discomfort)
| During and after procedure/stimulation and up to 15 min after stimulation. |
| University of Manitoba |
| Recruiting |
| Winnipeg |
| Manitoba |
| R3E 0J9 |
| Canada |
|
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |