Neuromodulation With Spinal Stimulation Methods
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: spinal stimulation-DCS, spinal stimulation-sham DCS, spinal stimulation-EPS, sham spinal stimulation-EPS.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level, Paraplegia, Spinal, Paraplegia, Incomplete. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device spinal stimulation-DCS
transcutaneous spinal stimulation by direct current stimulation - Other spinal stimulation-sham DCS
sham transcutaneous spinal stimulation by direct current stimulation - Other spinal stimulation-EPS
transcutaneous spinal stimulation by electrical pulsed stimulation - Other sham spinal stimulation-EPS
sham transcutaneous spinal stimulation by electrical pulsed stimulation
Primary outcome measures
- Motor response [Time frame: Immediately after stimulation (within 1-15 min)]
- Motor evoked potentials [Time frame: Immediately after stimulation (within 1-15 min)]
Secondary outcome measures (2)
- Blood pressure [Time frame: During the procedure/stimulation and up to 15 min after stimulation.]
- Perception of discomfort due to stimulation [Time frame: During and after procedure/stimulation and up to 15 min after stimulation.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Canada · 2 centers
- University of Manitoba — Winnipeg
- University of Manitoba — Winnipeg
Identifiers
NCT: NCT06272279 · HS23666(B2020:015)