Paraplegia, Incomplete, Paraplegia, Spinal, Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEspinal stimulation-DCS
transcutaneous spinal stimulation by direct current stimulation
OTHERspinal stimulation-sham DCS
sham transcutaneous spinal stimulation by direct current stimulation
OTHERspinal stimulation-EPS
transcutaneous spinal stimulation by electrical pulsed stimulation
OTHERsham spinal stimulation-EPS
sham transcutaneous spinal stimulation by electrical pulsed stimulation
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Semi-blinded, randomized block entry design, crossover intervention study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* spinal cord injury C4 to L4 * ability to understand and follow directions
Exclusion criteria
* history of seizures, head injury, concussion, unexplained loss of consciousness or if they lived with an implanted cochlear stimulator, brain/neurostimulator, cardiac pacemaker, medication infusion device or live with metal implants in their body or if they are pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor response | Immediately after stimulation (within 1-15 min) | H-reflex input output curve |
| Motor evoked potentials | Immediately after stimulation (within 1-15 min) | MEP input-output curve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | During the procedure/stimulation and up to 15 min after stimulation. | Measured (in arm) with inflatable cuff-automated, standard machine. |
| Perception of discomfort due to stimulation | During and after procedure/stimulation and up to 15 min after stimulation. | self-reporting on a scale ( the higher, the more discomfort) |
Countries
Canada
Contacts
Primary ContactKatinka Stecina, PhD
Backup ContactKristine Cowley, PhD
Outcome results
None listed