Spinal Cord InjuriesSCI-ES-WALKNCT06260735
Non-invasive Spinal Cord Stimulation After Spinal Cord Injury
A study testing Trans-spinal electrical stimulation, Electrical muscle activation and Treadmill walking in people with Spinal Cord Injuries and Spinal Cord Diseases, run by University of Manitoba at 1 site in Canada.
Trial summary
Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases
- What is being tested?
- Trans-spinal electrical stimulation, Electrical muscle activation and Treadmill walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has spinal cord injury, 6 mo or longer since injury
- Is between 20 and 65 years of age
- Has difficulty with trunk and/or lower limb function
- Stable medical condition
- Non-progressive etiology of spinal injury
- No ventilatory support
Who cannot join
- Genetic or degenerative etiology of spinal injury
- Need for ventilatory or other life-sustaining medical support
- History of cardiovascular or pulmonary complications (heart failure, severe hypertension etc.)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3E 0W2
Katinka Stecina, 204-789-3761, katinka.stecina@umanitoba.ca
About this study
Official title: Non-invasive Spinal Cord Stimulation for Improving Movement: Neuromodulation With Spinal Stimulation Methods and Individualized Locomotor Training
Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols.
This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.
Read the detailed description
This project will evaluate the effects of non-invasive lumbar ts-ES on locomotor function in people with incomplete motor SCI (iSCI) who retain some ability to stand or walk.
This study has 3 phases:
Baseline assessment - 2 sessions - week 1 -Lab visits #1-2
Locomotor training with varied electrical stimulation- 12 sessions - weeks 2-5 - Lab visits #3-14 (1hr, x3/week)
End of training assessment - 2 sessions - week 6- Lab visits #15-16.
Specific locomotor deficits of each participant will be evaluated, and their step-cycle-based peripheral muscle or nerve stimulation strategy will be determined accordingly to improve stance or step capacity. After augmenting their locomotor function with muscle or peripheral nerve stimulation-induced activation strategies that address particular and unique motor deficits, they will receive intermittent bouts of stance or locomotor training supplemented with ts-ES. The locomotor training will consist of standing/walking on a treadmill with appropriate bodyweight support and added muscle or peripheral nerve stimulation.
Specifically, the project aims to assess the following:
- Does combined muscle (NMES) or peripheral nerve (PN) stimulation with ts-ES during treadmill stepping facilitate locomotor performance?
- Does four weeks of combined training as described above (1hrx3/week) facilitate exercise capacity (measured by submaximal VO2) in persons with chronic iSCI?
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Being tested
- Trans-spinal electrical stimulation, Electrical muscle activation, Treadmill walking
- Keywords
- Trans-spinal electrical stimulation, Locomotor training, Functional electrical stimulation, Peripheral nerve stimulation
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-spinal electrical stimulationDevice
Trans-spinal electrical stimulation (ts-ES) at T11-L1 vertebral levels with short pulses at a set frequency (30Hz).
Electrical muscle activationDevice
Peripheral nerve (PN) or muscle (NMES) stimulation strategy was developed for each participant to optimize stance/walk capacity based on personal needs/preferences.
Treadmill walkingOther
Stepping on a treadmill with individually preferred speed.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill training combined with muscle and spinal cord stimulation | Experimental | Locomotor training is defined as walking on a treadmill with appropriate bodyweight support and augmented with muscle activation either by electrical nerve or muscle stimulation based on individual needs. Then, spinal stimulation will be integrated during training with on/off bouts alternating. Receives: Device: Trans-spinal electrical stimulation; Device: Electrical muscle activation; Other: Treadmill walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiological markers or stepping
Average step length, step height at ankle (cm).
Measured: Pre-training (on week 1) and within one week from end of training (on week 6)
Electromyography (EMG) of ankle extensor muscles
Mean RMS amplitude
Measured: Pre-training (on week 1) and within one week from end of training (on week 6)
Metabolic function testing
Breath-by-breath analysis of air in/out will be used to measure VO2max (mL/kg/min).
Measured: Pre-training (on week 1) and within one week from end of training (on week 6)
Secondary outcomes (4)
6 Min Walk Test
Measure distance (m) covered in 6 min walking, overground with device of choice (if using it at home/in community). Repeat with save device. Verbal encouragement and safety support in place during testing.
Measured: Pre-training (on week 1) and within one week from end of training (on week 6)
SCIM-Spinal Cord Independence Measure- Mobility scores
Rick Hansen Institute, Spinal Cord Independence Measure III - Mobility subsection, Questions 12-17. Scale: 0-20. Lower score means less mobility.
Measured: Pre-training (on week 1) and within one week from end of training (on week 6)
Autonomic scores
American Spinal Injury Association-Autonomic Standards assessment form-General Autonomic Function \& Lower Urinary tract, bowel, and sexual function components. Scale: 0-48. Lower scores mean less autonomic function.
Measured: Pre-training (on week 1) and within one week from end of training (on week 6)
Rate or Perceived Exertion (RPE) of Submaximal VO2 testing
Borg scale from 6-20 (chart used from Heart Online open source). Scale: 6-20. Lower scores mean less exertion (less tiring).
Measured: Pre-training (on week 1) and within one week from end of training (on week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start15 Jun 2023
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Nov 2024 (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.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katinka Stecina, University of Manitoba
- Investigators
- Katinka Stecina, Principal investigator, University of ManitobaKristine Cowley, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260735
- Sponsor's protocol ID
- HS25897 (H2023:073)
- Other IDs
- URGP#51472, RGPIN-2015-05703
- Acronym
- SCI-ES-WALK
- Status last verified
- Feb 2024
- First submitted
- 28 Nov 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Spinal Cord Stimulation for Improving Movement: Neuromodulation With Spinal Stimulation Methods and Individualized Locomotor Training
- ClinicalTrials.gov ID
- NCT06260735
- Acronym / sponsor ID
- SCI-ES-WALK / HS25897 (H2023:073)
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Keywords
- Trans-spinal electrical stimulation, Locomotor training, Functional electrical stimulation, Peripheral nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 15 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.
Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols.
This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.
Detailed description
This project will evaluate the effects of non-invasive lumbar ts-ES on locomotor function in people with incomplete motor SCI (iSCI) who retain some ability to stand or walk.
This study has 3 phases:
Baseline assessment - 2 sessions - week 1 -Lab visits #1-2
Locomotor training with varied electrical stimulation- 12 sessions - weeks 2-5 - Lab visits #3-14 (1hr, x3/week)
End of training assessment - 2 sessions - week 6- Lab visits #15-16.
Specific locomotor deficits of each participant will be evaluated, and their step-cycle-based peripheral muscle or nerve stimulation strategy will be determined accordingly to improve stance or step capacity. After augmenting their locomotor function with muscle or peripheral nerve stimulation-induced activation strategies that address particular and unique motor deficits, they will receive intermittent bouts of stance or locomotor training supplemented with ts-ES. The locomotor training will consist of standing/walking on a treadmill with appropriate bodyweight support and added muscle or peripheral nerve stimulation.
Specifically, the project aims to assess the following:
- Does combined muscle (NMES) or peripheral nerve (PN) stimulation with ts-ES during treadmill stepping facilitate locomotor performance?
- Does four weeks of combined training as described above (1hrx3/week) facilitate exercise capacity (measured by submaximal VO2) in persons with chronic iSCI?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treadmill training combined with muscle and spinal cord stimulation | Experimental | Device: Trans-spinal electrical stimulation, Device: Electrical muscle activation, Other: Treadmill walkingLocomotor training is defined as walking on a treadmill with appropriate bodyweight support and augmented with muscle activation either by electrical nerve or muscle stimulation based on individual needs. Then, spinal stimulation will be integrated during training with on/off bouts alternating. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has spinal cord injury, 6 mo or longer since injury
- Is between 20 and 65 years of age
- Has difficulty with trunk and/or lower limb function
- Stable medical condition
- Non-progressive etiology of spinal injury
Key exclusion criteria (3 listed)
- Genetic or degenerative etiology of spinal injury
- Need for ventilatory or other life-sustaining medical support
- History of cardiovascular or pulmonary complications (heart failure, severe hypertension etc.)
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 |
|---|---|---|
| Trans-spinal electrical stimulationTrans-spinal electrical stimulation (ts-ES) at T11-L1 vertebral levels with short pulses at a set frequency (30Hz). | Device | Treadmill training combined with muscle and spinal cord stimulation |
| Electrical muscle activationPeripheral nerve (PN) or muscle (NMES) stimulation strategy was developed for each participant to optimize stance/walk capacity based on personal needs/preferences. | Device | Treadmill training combined with muscle and spinal cord stimulation |
| Treadmill walkingStepping on a treadmill with individually preferred speed. | Other | Treadmill training combined with muscle and spinal cord stimulation |
Primary outcome
Neurophysiological markers or stepping
Time frame: Pre-training (on week 1) and within one week from end of training (on week 6)
Average step length, step height at ankle (cm).
Electromyography (EMG) of ankle extensor muscles
Time frame: Pre-training (on week 1) and within one week from end of training (on week 6)
Mean RMS amplitude
Metabolic function testing
Time frame: Pre-training (on week 1) and within one week from end of training (on week 6)
Breath-by-breath analysis of air in/out will be used to measure VO2max (mL/kg/min).
4 secondary outcomes
6 Min Walk Test
Time frame: Pre-training (on week 1) and within one week from end of training (on week 6)
SCIM-Spinal Cord Independence Measure- Mobility scores
Time frame: Pre-training (on week 1) and within one week from end of training (on week 6)
Autonomic scores
Time frame: Pre-training (on week 1) and within one week from end of training (on week 6)
Rate or Perceived Exertion (RPE) of Submaximal VO2 testing
Time frame: Pre-training (on week 1) and within one week from end of training (on week 6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Katinka Stecina principal investigator
University of Manitoba
Kristine Cowley principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-spinal electrical stimulation, Electrical muscle activation and Treadmill walking in people with Spinal Cord Injuries and Spinal Cord Diseases, run by University of Manitoba at 1 site 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katinka Stecina (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?
Neurophysiological markers or stepping (time frame: Pre-training (on week 1) and within one week from end of training (on week 6)). The study lists 3 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 15 Feb 2024.