Spinal Cord InjuriesNCT06272279
Neuromodulation With Spinal Stimulation Methods
A study testing spinal stimulation-DCS and spinal stimulation-EPS in people with Spinal Cord Injuries and Spinal Cord Injury at C5-C7 Level, run by University of Manitoba at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level, Paraplegia, Spinal
- What is being tested?
- spinal stimulation-DCS and spinal stimulation-EPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Mar 2024to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- spinal cord injury C4 to L4
- ability to understand and follow directions
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Enrolling by invitation
University of Manitoba
Winnipeg, Manitoba, R3E 0J9
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3E 0J9
Katinka Stecina, Ph.D., 2047893761, Katinka.Stecina@umanitoba.ca
Kristine Cowley, Ph.D., 2047893305, Kristine.Cowley@umanitoba.ca
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level, Paraplegia, Spinal, Paraplegia, Incomplete
- Being tested
- spinal stimulation-DCS, spinal stimulation-sham DCS, spinal stimulation-EPS, sham spinal stimulation-EPS
- Medical subject headings
- Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal stimulation-DCSDevice
transcutaneous spinal stimulation by direct current stimulation
spinal stimulation-sham DCSOther
sham transcutaneous spinal stimulation by direct current stimulation
spinal stimulation-EPSOther
transcutaneous spinal stimulation by electrical pulsed stimulation
sham spinal stimulation-EPSOther
sham transcutaneous spinal stimulation by electrical pulsed stimulation
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord stimulation | Experimental | Spinal cord stimulation will be administered to participants for 15 min. Receives: Device: spinal stimulation-DCS; Other: spinal stimulation-EPS |
| Shamspinal cord stimulation | Sham comparator | Sham spinal cord stimulation will be administered to participants for 15 min. Receives: Other: spinal stimulation-sham DCS; Other: sham spinal stimulation-EPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor response
H-reflex input output curve
Measured: Immediately after stimulation (within 1-15 min)
Motor evoked potentials
MEP input-output curve
Measured: Immediately after stimulation (within 1-15 min)
Secondary outcomes (2)
Blood pressure
Measured (in arm) with inflatable cuff-automated, standard machine.
Measured: During the procedure/stimulation and up to 15 min after stimulation.
Perception of discomfort due to stimulation
self-reporting on a scale ( the higher, the more discomfort)
Measured: During and after procedure/stimulation and up to 15 min after stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Mar 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Semi-blinded, randomized block entry design, crossover intervention study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272279
- Sponsor's protocol ID
- HS23666(B2020:015)
- Status last verified
- Feb 2025
- First submitted
- 9 Mar 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, we will consider making anonymized data available for analysis by other researchers
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation With Spinal Stimulation Methods
- ClinicalTrials.gov ID
- NCT06272279
- Acronym / sponsor ID
- HS23666(B2020:015)
- Conditions
- Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level, Paraplegia, Spinal, Paraplegia, Incomplete
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Semi-blinded, randomized block entry design, crossover intervention study.
| Arm | Type | Receives |
|---|---|---|
| Spinal cord stimulation | Experimental | Device: spinal stimulation-DCS, Other: spinal stimulation-EPSSpinal cord stimulation will be administered to participants for 15 min. |
| Shamspinal cord stimulation | Sham comparator | Other: spinal stimulation-sham DCS, Other: sham spinal stimulation-EPSSham spinal cord stimulation will be administered to participants for 15 min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- spinal cord injury C4 to L4
- ability to understand and follow directions
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal stimulation-DCStranscutaneous spinal stimulation by direct current stimulation | Device | Spinal cord stimulation |
| spinal stimulation-sham DCSsham transcutaneous spinal stimulation by direct current stimulation | Other | Shamspinal cord stimulation |
| spinal stimulation-EPStranscutaneous spinal stimulation by electrical pulsed stimulation | Other | Spinal cord stimulation |
| sham spinal stimulation-EPSsham transcutaneous spinal stimulation by electrical pulsed stimulation | Other | Shamspinal cord stimulation |
Primary outcome
Motor response
Time frame: Immediately after stimulation (within 1-15 min)
H-reflex input output curve
Motor evoked potentials
Time frame: Immediately after stimulation (within 1-15 min)
MEP input-output curve
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: Yes. Upon request, we will consider making anonymized data available for analysis by other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal stimulation-DCS and spinal stimulation-EPS in people with Spinal Cord Injuries and Spinal Cord Injury at C5-C7 Level, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katinka Stecina, PhD (204 789 3761, katinka.stecina@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor response (time frame: Immediately after stimulation (within 1-15 min)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.