Spinal Cord Injuries (Complete and Incomplete)NCT07898150
Feasibility of Transcutaneous Spinal Stimulation in Rehabilitation
A study testing Transcutaneous Spinal Stimulation, Inpatient SCI Physiotherapy and Inpatient SCI Occupational Therapy in people with Spinal Cord Injuries (Complete and Incomplete) and Spinal Cord Injuries (SCI), run by Janelle Unger at 1 site in Canada.
Trial summary
Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation approach that delivers electrical stimulation to spinal nerve roots through electrodes placed over the spinal cord. TSS may support motor and functional recovery following spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI), Spinal Cord Injuries and Disorders (SCI/D)
- What is being tested?
- Transcutaneous Spinal Stimulation, Inpatient SCI Physiotherapy and Inpatient SCI Occupational Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 30 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of SCI
- Enrolled in either the FES-Cycling program at Parkwood Institute for at least 6 weeks, or admitted to the In-Patient SCI Rehabilitation program at Parkwood Institute.
- Be able to communicate and provide informed consent in English
Who cannot join
- Experiencing progressive worsening of symptoms related to their SCI
- Have a secondary condition significantly impacting their ability to participate in active rehabilitation (e.g., uncontrolled orthostatic hypotension, high fracture risk, inability to follow directions, etc.).
- Clinical team determines that the person has contraindications to using TSS (i.e., poor skin integrity on their back, implanted metal device along their spine, pacemaker, active fracture, pregnancy, cancer of the spine or adjacent to a stimulation area, uncontrolled epilepsy, uncontrolled autonomic dysreflexia).
- Have an allergy to adhesives.
- Have not had Botox to upper or lower extremities in the last three months.
- Are not currently participating in another clinical trial with similar objectives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Parkwood Institute - Main Building
London, Ontario, N6C 0A7
Jeff Weiler, Gray Centre Manager, PhD, 519-646-6100 ext. 42612, jeff.weiler@sjhc.london.on.ca
About this study
Official title: Exploring the Feasibility of Integrating Transcutaneous Spinal Stimulation Into Inpatient and Outpatient Rehabilitation
Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation approach that delivers electrical stimulation to spinal nerve roots through electrodes placed over the spinal cord. TSS may support motor and functional recovery following spinal cord injury (SCI). However, therapeutic potential alone does not establish whether TSS can be feasibly integrated into routine rehabilitation. Clinical implementation introduces practical considerations including clinician training, device setup and operation, time, safety monitoring, acceptability, organizational resources, and compatibility with existing rehabilitation workflows.
This study will evaluate the feasibility of integrating TSS into two existing SCI rehabilitation programs at Parkwood Institute: outpatient upper- and lower-extremity functional electrical stimulation (FES) cycling using the Xcite system with TSS functionality, and routine inpatient physiotherapy and occupational therapy using the Stim2Go device. Evaluating TSS across two rehabilitation contexts will identify setting-specific barriers, facilitators, and implementation requirements.
Read more
The primary objective is to evaluate the feasibility, safety, acceptability, and implementation strategies required to integrate TSS into outpatient FES cycling and inpatient SCI rehabilitation. Secondary objectives are to explore preliminary changes in clinical and functional outcomes and synthesize implementation findings into evidence-informed recommendations for TSS implementation.
A multi-methods, multi-intervention case series design will be used. Implementation will be guided by the Active Implementation Frameworks and a Training and Coaching Model. Feasibility will be evaluated using Bowen et al.'s Feasibility Framework and the Theoretical Framework of Acceptability, examining acceptability, demand, implementation, practicality, integration, and limited efficacy.
The study will recruit 15 adults with SCI and up to 10 clinicians. Ten patient participants will be recruited from the outpatient FES cycling program and five from inpatient SCI rehabilitation. Up to 10 clinicians who integrate TSS into participant care will also be recruited.
Outpatient participants will receive TSS during their regularly scheduled FES cycling sessions for four weeks. TSS will be delivered during routine 30-45-minute cycling sessions one to two times per week, targeting the cervical spine for upper-extremity cycling and lower thoracic/lumbar spine for lower-extremity cycling. Inpatient participants will receive TSS using Stim2Go during routine physiotherapy and occupational therapy for a minimum of four weeks, with a target of at least three TSS-assisted sessions per week. TSS will be embedded within usual rehabilitation activities, including transfer training, pre-gait and mobility training, activity-based therapy, and upper-extremity task-specific training.
Primary feasibility outcomes will include recruitment, attrition, intervention adherence, adverse events, and patient and clinician experiences. Following the implementation period, patient participants will complete an acceptability survey and semi-structured interview. Clinicians will complete an acceptability survey and participate in a focus group exploring feasibility, acceptability, barriers, facilitators, and lessons learned from integrating TSS into practice.
Exploratory clinical outcomes will also be examined. For outpatient participants, FES cycling outcomes from the four weeks before TSS will be compared descriptively with the four-week TSS period, including session time, distance, asymmetry, time without motor support, energy, power, crank velocity, and stimulation parameters. For inpatient participants, baseline and post-intervention outcomes will assess standing, walking, balance, mobility, endurance, upper- and lower-extremity strength, upper-extremity function when relevant, and independence in daily activities.
Quantitative feasibility, demographic, survey, cycling, and clinical data will be summarized descriptively and visually. Individual changes in inpatient clinical outcomes will be interpreted using minimal detectable change values where available. Qualitative interview and focus group data will undergo codebook thematic analysis informed by interpretive description to identify implementation experiences, barriers, facilitators, and recommendations.
This study will provide real-world evidence on whether and how TSS can be safely and feasibly incorporated into existing SCI rehabilitation services. Evaluating two devices across inpatient and outpatient contexts will identify practical implementation supports and setting-specific considerations not captured in laboratory-based research. Findings will inform recommendations to support adoption and sustained use of TSS across SCI rehabilitation settings in Canada.
- Conditions
- Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI), Spinal Cord Injuries and Disorders (SCI/D)
- Being tested
- Transcutaneous Spinal Stimulation, Inpatient SCI Physiotherapy, Inpatient SCI Occupational Therapy, FES Cycling
- Keywords
- Transcutaneous Spinal Stimulation, Transcutaneous Spinal Cord Stimulation, Rehabilitation, Implementation Science, Feasibility Trial, Neuromodulation, Clinical Implementation, Acceptability
- Medical subject headings
- Spinal Cord Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal StimulationDevice
Also called Transcutaneous Spinal Cord Stimulation, TSS, TSCS
Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation intervention that delivers electrical stimulation to spinal nerve roots through surface electrodes placed over the spinal cord. TSS will be delivered concurrently with participants' existing rehabilitation activities to modulate spinal neural circuitry and support motor activation during functional training. Stimulation will use a biphasic waveform with a 1000 μs pulse duration, frequency of 30-35 Hz, and amplitude up to 100 mA, individualized based on participant response and tolerance. Depending on the rehabilitation program and therapeutic goals, stimulation will be delivered using either the Xcite system with TSS functionality during outpatient FES cycling or the Stim2Go device during inpatient physiotherapy and occupational therapy.
Inpatient SCI PhysiotherapyOther
Also called Conventional Physiotherapy, Conventional Physical Therapy
Inpatient spinal cord injury physiotherapy consists of individualized rehabilitation delivered as part of routine clinical care. Physiotherapy focuses on improving mobility, strength, balance, functional independence, and upper- and lower-extremity function according to each participant's rehabilitation goals and abilities. Interventions may include activity-based therapy, bed mobility and transfer training, sitting and standing balance, strengthening, pre-gait training, walking and mobility training, and other clinically appropriate therapeutic activities. Participants typically receive approximately five physiotherapy sessions per week, with sessions lasting approximately 45-90 minutes. Treatment selection, intensity, and progression are individualized by the treating physiotherapist based on the participant's clinical presentation, tolerance, and rehabilitation goals.
Inpatient SCI Occupational TherapyOther
Also called Conventional Occupational Therapy
Inpatient spinal cord injury occupational therapy consists of individualized rehabilitation delivered as part of routine clinical care. Occupational therapy focuses on improving independence and participation in daily activities based on each participant's functional abilities and rehabilitation goals. Interventions may include upper-extremity strengthening and task-specific training, fine motor and hand function activities, activities of daily living such as dressing, grooming, and feeding, transfer and mobility-related activities, equipment assessment and training, and other clinically appropriate therapeutic activities. Participants typically receive approximately five occupational therapy sessions per week, with sessions lasting approximately 45-90 minutes. Treatment selection, intensity, and progression are individualized by the treating occupational therapist based on the participant's clinical presentation, tolerance, and rehabilitation goals.
FES CyclingOther
Also called Functional Electrical Stimulation Cycling
Functional electrical stimulation (FES) cycling consists of upper- or lower-extremity cycling using an RTI 300 cycle ergometer with electrical stimulation applied to selected muscles to facilitate active cycling. Upper-extremity FES cycling may stimulate muscles including the deltoids, biceps, triceps, wrist and finger flexors and extensors, and scapular stabilizers. Lower-extremity FES cycling may stimulate the gluteals, quadriceps, hamstrings, gastrocnemius, and tibialis anterior. Participants typically complete one to two FES cycling sessions per week, with sessions lasting approximately 60-90 minutes. Muscle selection and stimulation parameters are individualized according to each participant's functional abilities, therapeutic goals, and response to stimulation.
| Study group | Role | What they receive |
|---|---|---|
| TSS-Augmented Inpatient SCI Rehabilitation Group | Experimental | Participants (n=5) will receive transcutaneous spinal stimulation (TSS) using the Stim2Go device during routine inpatient physiotherapy (PT) and occupational therapy (OT) for a minimum of 4 weeks. Participants typically receive approximately 10 rehabilitation sessions/week (5 PT and 5 OT), lasting 45-90 minutes. TSS will be embedded within usual rehabilitation without altering its intensity or structure, with a target of at least 3 TSS-assisted sessions/week and additional sessions based on tolerance. TSS will be incorporated into clinically appropriate activities such as transfer, pre-gait and mobility, activity-based, and upper-extremity task-specific training. PTs and OTs will individualize stimulation parameters within a biphasic waveform, 1000 μs pulse duration, 30-35 Hz frequency, and up to 100 mA amplitude. Parameters will be documented for each session. Receives: Device: Transcutaneous Spinal Stimulation; Other: Inpatient SCI Physiotherapy; Other: Inpatient SCI Occupational Therapy |
| TSS-Augmented Outpatient FES Cycling Program | Experimental | Participants (n=10; 5 upper- and 5 lower-extremity riders) will be recruited from Parkwood Institute's outpatient FES Cycling Program. During the 4-week intervention, transcutaneous spinal stimulation (TSS) will be added to participants' usual FES cycling using the Xcite system with TSS functionality and RTI 300 cycle ergometers. Participants will receive TSS during routine 30-45-minute FES cycling sessions, 1-2 times/week. TSS will be applied over the cervical spine (C2-T1) during upper-extremity cycling and lower thoracic/lumbar spine (T12-L5) during lower-extremity cycling. Stimulation will use a biphasic waveform, 1000 μs pulse duration, 30-35 Hz frequency, and up to 100 mA amplitude. Trained clinical leads will oversee TSS delivery and clinician training. Participants will otherwise continue their usual individualized FES cycling program. Receives: Device: Transcutaneous Spinal Stimulation; Other: FES Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
The number of participants that consent given the number of potential participants that are approached about the study, expressed as a percentage.
Measured: During study enrolment
Intervention Adherence
The number of intervention sessions attended by participants compared to the anticipated number of sessions, expressed as a percentage.
Measured: Collected at the end of the intervention (Week 4).
Attrition Rate
The number of participants who are withdrawn from the study or drop out, expressed as a percentage of the total sample.
Measured: Collected at the end of the intervention (Week 4).
Adverse Events
An Adverse Event reporting form will be used to track the number, type, and severity of adverse events. This data will be reported descriptively.
Measured: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Feasibility Survey
All participants will complete a survey about the use of TSS during their therapy. This survey uses a 7-point Likert scale (strongly disagree to strongly agree) to score a total of 13 items, meaning the minimum score would be 13, indicating low feasibility, and the maximum score would be 91, indicating high feasibility. The findings will be reported descriptively.
Measured: Collected at the end of the intervention (Week 4).
Semi-Structured Interview
A semi-structured interview will ask participants for their perspectives on the intervention. The data will be reported qualitatively.
Measured: Collected at the end of the intervention (Week 4).
Secondary outcomes (17)
Session Time
Time spent in each session, along with time using TSS. Measured in minutes.
Measured: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Distance Travelled
For participants using the FES bike, measured in meters.
Measured: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Asymmetry Output
For participants using the FES bike, measured as percentage of time using the right and left legs.
Measured: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Time Off Motor Support
For participants using the FES bike, measured as percentage of time spent in active compared to passive cycling.
Measured: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Energy
For participants using the FES bike, measured as kilocalories per hour.
Measured: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Power
For participants using the FES bike, measured as average Watts over each session.
Measured: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Velocity
For participants using the FES bike, measured as average revolutions per minute (RPM) over each session.
Measured: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Standing and Walking Assessment Tool (SWAT)
For participants in inpatient rehabilitation. Standardized functional scale. Lowest functional stage of 0 (inability to stand) and highest functional stage of 4 (unimpaired community walking).
Measured: Collected at baseline and at the end of the intervention (Week 4).
Berg Balance Scale
For participants in inpatient rehabilitation in SWAT stages 1-4. Standardized scale with 14 items scored from 0 to 4, with a minimum score of 0, indicating the lowest level of function, and a maximum score of 52, indicating the highest functional level.
Measured: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
Modified Timed-Up-and-Go
For participants in inpatient rehabilitation in SWAT stages 2-4. Measured in time taken to complete (seconds).
Measured: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
10 Meter Walk Test
For participants in inpatient rehabilitation in SWAT stages 2-4. Measured in time taken to complete which is converted to walking speed (meters per second).
Measured: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
Six Minute Walk Test
For participants in inpatient rehabilitation in SWAT stages 3-4. Measured in total distance walked (meters).
Measured: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
Activities-specific Balance Confidence Scale
For participants in inpatient rehabilitation in SWAT stages 2-4. Standardized scale with 16 items scored from 0 to 100 and then averaged, with a minimum score of 0, indicating the lowest level of confidence, and a maximum score of 100, indicating the highest confidence level.
Measured: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
Manual Muscle Testing
For participants in inpatient rehabilitation. Standardized scale with 16 muscles scored from 0 (no muscle activation) to 5 (full strength against resistance) bilaterally. Total scores for the upper and lower extremity summed.
Measured: Collected at baseline and at the end of the intervention (Week 4).
Grip Strength
For participants in inpatient rehabilitation, measured in kilograms.
Measured: Collected at baseline and at the end of the intervention (Week 4).
Graded Redefined Assessment of Strength, Sensibility, and Prehension
For participants in inpatient rehabilitation with upper extremity function identified as a goal. Standardized scale with 3 components and 20 items scored bilaterally. Minimum score of 0, indicating the lowest level of function, and a maximum score of 94, indicating the highest level of function.
Measured: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
Spinal Cord Independence Measure
For participants in inpatient rehabilitation. Standardized scale with 4 components and 19 items. Minimum score of 0, indicating the lowest level of independence, and a maximum score of 100, indicating the highest level of independence.
Measured: Collected at baseline and at the end of the intervention (Week 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (Complete and Incomplete)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a single-group, multi-intervention case series design to evaluate the feasibility of integrating transcutaneous spinal stimulation (TSS) into existing spinal cord injury rehabilitation. Participants will receive TSS within their existing clinical program: either outpatient functional electrical stimulation cycling or routine inpatient physiotherapy and occupational therapy. The two clinical contexts are not intended as comparative study arms; rather, each will be evaluated to understand the feasibility, safety, acceptability, and implementation of TSS within its respective rehabilitation setting.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janelle Unger
- Sponsor type
- University, hospital or other
- Collaborators
- Praxis Spinal Cord Institute
- Responsible party
- Sponsor-investigator, Janelle Unger, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898150
- Sponsor's protocol ID
- SCI Adopt: Rapid TSS Clinical
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data (IPD) underlying the results reported from this study may be shared with qualified researchers for research purposes. Data will be shared only after appropriate de-identification, consent obtained, and in accordance with institutional research ethics, privacy, and data-sharing requirements. Supporting study documentation may also be made available where appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of Integrating Transcutaneous Spinal Stimulation Into Inpatient and Outpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT07898150
- Acronym / sponsor ID
- SCI Adopt: Rapid TSS Clinical
- Conditions
- Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI), Spinal Cord Injuries and Disorders (SCI/D)
- Keywords
- Transcutaneous Spinal Stimulation, Transcutaneous Spinal Cord Stimulation, Rehabilitation, Implementation Science, Feasibility Trial, Neuromodulation, Clinical Implementation, Acceptability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Janelle UngerUniversity, hospital or other
- Collaborators
- Praxis Spinal Cord Institute
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation approach that delivers electrical stimulation to spinal nerve roots through electrodes placed over the spinal cord. TSS may support motor and functional recovery following spinal cord injury (SCI). However, therapeutic potential alone does not establish whether TSS can be feasibly integrated into routine rehabilitation. Clinical implementation introduces practical considerations including clinician training, device setup and operation, time, safety monitoring, acceptability, organizational resources, and compatibility with existing rehabilitation workflows.
This study will evaluate the feasibility of integrating TSS into two existing SCI rehabilitation programs at Parkwood Institute: outpatient upper- and lower-extremity functional electrical stimulation (FES) cycling using the Xcite system with TSS functionality, and routine inpatient physiotherapy and occupational therapy using the Stim2Go device. Evaluating TSS across two rehabilitation contexts will identify setting-specific barriers, facilitators, and implementation requirements.
The primary objective is to evaluate the feasibility, safety, acceptability, and implementation strategies required to integrate TSS into outpatient FES cycling and inpatient SCI rehabilitation. Secondary objectives are to explore preliminary changes in clinical and functional outcomes and synthesize implementation findings into evidence-informed recommendations for TSS implementation.
A multi-methods, multi-intervention case series design will be used. Implementation will be guided by the Active Implementation Frameworks and a Training and Coaching Model. Feasibility will be evaluated using Bowen et al.'s Feasibility Framework and the Theoretical Framework of Acceptability, examining acceptability, demand, implementation, practicality, integration, and limited efficacy.
The study will recruit 15 adults with SCI and up to 10 clinicians. Ten patient participants will be recruited from the outpatient FES cycling program and five from inpatient SCI rehabilitation. Up to 10 clinicians who integrate TSS into participant care will also be recruited.
Outpatient participants will receive TSS during their regularly scheduled FES cycling sessions for four weeks. TSS will be delivered during routine 30-45-minute cycling sessions one to two times per week, targeting the cervical spine for upper-extremity cycling and lower thoracic/lumbar spine for lower-extremity cycling. Inpatient participants will receive TSS using Stim2Go during routine physiotherapy and occupational therapy for a minimum of four weeks, with a target of at least three TSS-assisted sessions per week. TSS will be embedded within usual rehabilitation activities, including transfer training, pre-gait and mobility training, activity-based therapy, and upper-extremity task-specific training.
Primary feasibility outcomes will include recruitment, attrition, intervention adherence, adverse events, and patient and clinician experiences. Following the implementation period, patient participants will complete an acceptability survey and semi-structured interview. Clinicians will complete an acceptability survey and participate in a focus group exploring feasibility, acceptability, barriers, facilitators, and lessons learned from integrating TSS into practice.
Exploratory clinical outcomes will also be examined. For outpatient participants, FES cycling outcomes from the four weeks before TSS will be compared descriptively with the four-week TSS period, including session time, distance, asymmetry, time without motor support, energy, power, crank velocity, and stimulation parameters. For inpatient participants, baseline and post-intervention outcomes will assess standing, walking, balance, mobility, endurance, upper- and lower-extremity strength, upper-extremity function when relevant, and independence in daily activities.
Quantitative feasibility, demographic, survey, cycling, and clinical data will be summarized descriptively and visually. Individual changes in inpatient clinical outcomes will be interpreted using minimal detectable change values where available. Qualitative interview and focus group data will undergo codebook thematic analysis informed by interpretive description to identify implementation experiences, barriers, facilitators, and recommendations.
This study will provide real-world evidence on whether and how TSS can be safely and feasibly incorporated into existing SCI rehabilitation services. Evaluating two devices across inpatient and outpatient contexts will identify practical implementation supports and setting-specific considerations not captured in laboratory-based research. Findings will inform recommendations to support adoption and sustained use of TSS across SCI rehabilitation settings in Canada.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a single-group, multi-intervention case series design to evaluate the feasibility of integrating transcutaneous spinal stimulation (TSS) into existing spinal cord injury rehabilitation. Participants will receive TSS within their existing clinical program: either outpatient functional electrical stimulation cycling or routine inpatient physiotherapy and occupational therapy. The two clinical contexts are not intended as comparative study arms; rather, each will be evaluated to understand the feasibility, safety, acceptability, and implementation of TSS within its respective rehabilitation setting.
| Arm | Type | Receives |
|---|---|---|
| TSS-Augmented Inpatient SCI Rehabilitation Group | Experimental | Device: Transcutaneous Spinal Stimulation, Other: Inpatient SCI Physiotherapy, Other: Inpatient SCI Occupational TherapyParticipants (n=5) will receive transcutaneous spinal stimulation (TSS) using the Stim2Go device during routine inpatient physiotherapy (PT) and occupational therapy (OT) for a minimum of 4 weeks. Participants typically receive approximately 10 rehabilitation sessions/week (5 PT and 5 OT), lasting 45-90 minutes. TSS will be embedded within usual rehabilitation without altering its intensity or structure, with a target of at least 3 TSS-assisted sessions/week and additional sessions based on tolerance. TSS will be incorporated into clinically appropriate activities such as transfer, pre-gait and mobility, activity-based, and upper-extremity task-specific training. PTs and OTs will individualize stimulation parameters within a biphasic waveform, 1000 μs pulse duration, 30-35 Hz frequency, and up to 100 mA amplitude. Parameters will be documented for each session. |
| TSS-Augmented Outpatient FES Cycling Program | Experimental | Device: Transcutaneous Spinal Stimulation, Other: FES CyclingParticipants (n=10; 5 upper- and 5 lower-extremity riders) will be recruited from Parkwood Institute's outpatient FES Cycling Program. During the 4-week intervention, transcutaneous spinal stimulation (TSS) will be added to participants' usual FES cycling using the Xcite system with TSS functionality and RTI 300 cycle ergometers. Participants will receive TSS during routine 30-45-minute FES cycling sessions, 1-2 times/week. TSS will be applied over the cervical spine (C2-T1) during upper-extremity cycling and lower thoracic/lumbar spine (T12-L5) during lower-extremity cycling. Stimulation will use a biphasic waveform, 1000 μs pulse duration, 30-35 Hz frequency, and up to 100 mA amplitude. Trained clinical leads will oversee TSS delivery and clinician training. Participants will otherwise continue their usual individualized FES cycling program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of SCI
- Enrolled in either the FES-Cycling program at Parkwood Institute for at least 6 weeks, or admitted to the In-Patient SCI Rehabilitation program at Parkwood Institute.
- Be able to communicate and provide informed consent in English
Key exclusion criteria (6 listed)
- Experiencing progressive worsening of symptoms related to their SCI
- Have a secondary condition significantly impacting their ability to participate in active rehabilitation (e.g., uncontrolled orthostatic hypotension, high fracture risk, inability to follow directions, etc.).
- Clinical team determines that the person has contraindications to using TSS (i.e., poor skin integrity on their back, implanted metal device along their spine, pacemaker, active fracture, pregnancy, cancer of the spine or adjacent to a stimulation area, uncontrolled epilepsy, uncontrolled autonomic dysreflexia).
- Have an allergy to adhesives.
- Have not had Botox to upper or lower extremities in the last three months.
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 |
|---|---|---|
| Transcutaneous Spinal StimulationAlso: Transcutaneous Spinal Cord Stimulation, TSS, TSCSTranscutaneous spinal stimulation (TSS) is a non-invasive neuromodulation intervention that delivers electrical stimulation to spinal nerve roots through surface electrodes placed over the spinal cord. TSS will be delivered concurrently with participants' existing rehabilitation activities to modulate spinal neural circuitry and support motor activation during functional training. Stimulation will use a biphasic waveform with a 1000 μs pulse duration, frequency of 30-35 Hz, and amplitude up to 100 mA, individualized based on participant response and tolerance. Depending on the rehabilitation program and therapeutic goals, stimulation will be delivered using either the Xcite system with TSS functionality during outpatient FES cycling or the Stim2Go device during inpatient physiotherapy and occupational therapy. | Device | TSS-Augmented Inpatient SCI Rehabilitation Group, TSS-Augmented Outpatient FES Cycling Program |
| Inpatient SCI PhysiotherapyAlso: Conventional Physiotherapy, Conventional Physical TherapyInpatient spinal cord injury physiotherapy consists of individualized rehabilitation delivered as part of routine clinical care. Physiotherapy focuses on improving mobility, strength, balance, functional independence, and upper- and lower-extremity function according to each participant's rehabilitation goals and abilities. Interventions may include activity-based therapy, bed mobility and transfer training, sitting and standing balance, strengthening, pre-gait training, walking and mobility training, and other clinically appropriate therapeutic activities. Participants typically receive approximately five physiotherapy sessions per week, with sessions lasting approximately 45-90 minutes. Treatment selection, intensity, and progression are individualized by the treating physiotherapist based on the participant's clinical presentation, tolerance, and rehabilitation goals. | Other | TSS-Augmented Inpatient SCI Rehabilitation Group |
| Inpatient SCI Occupational TherapyAlso: Conventional Occupational TherapyInpatient spinal cord injury occupational therapy consists of individualized rehabilitation delivered as part of routine clinical care. Occupational therapy focuses on improving independence and participation in daily activities based on each participant's functional abilities and rehabilitation goals. Interventions may include upper-extremity strengthening and task-specific training, fine motor and hand function activities, activities of daily living such as dressing, grooming, and feeding, transfer and mobility-related activities, equipment assessment and training, and other clinically appropriate therapeutic activities. Participants typically receive approximately five occupational therapy sessions per week, with sessions lasting approximately 45-90 minutes. Treatment selection, intensity, and progression are individualized by the treating occupational therapist based on the participant's clinical presentation, tolerance, and rehabilitation goals. | Other | TSS-Augmented Inpatient SCI Rehabilitation Group |
| FES CyclingAlso: Functional Electrical Stimulation CyclingFunctional electrical stimulation (FES) cycling consists of upper- or lower-extremity cycling using an RTI 300 cycle ergometer with electrical stimulation applied to selected muscles to facilitate active cycling. Upper-extremity FES cycling may stimulate muscles including the deltoids, biceps, triceps, wrist and finger flexors and extensors, and scapular stabilizers. Lower-extremity FES cycling may stimulate the gluteals, quadriceps, hamstrings, gastrocnemius, and tibialis anterior. Participants typically complete one to two FES cycling sessions per week, with sessions lasting approximately 60-90 minutes. Muscle selection and stimulation parameters are individualized according to each participant's functional abilities, therapeutic goals, and response to stimulation. | Other | TSS-Augmented Outpatient FES Cycling Program |
Primary outcome
Recruitment Rate
Time frame: During study enrolment
The number of participants that consent given the number of potential participants that are approached about the study, expressed as a percentage.
Intervention Adherence
Time frame: Collected at the end of the intervention (Week 4).
The number of intervention sessions attended by participants compared to the anticipated number of sessions, expressed as a percentage.
Attrition Rate
Time frame: Collected at the end of the intervention (Week 4).
The number of participants who are withdrawn from the study or drop out, expressed as a percentage of the total sample.
Adverse Events
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
An Adverse Event reporting form will be used to track the number, type, and severity of adverse events. This data will be reported descriptively.
Feasibility Survey
Time frame: Collected at the end of the intervention (Week 4).
All participants will complete a survey about the use of TSS during their therapy. This survey uses a 7-point Likert scale (strongly disagree to strongly agree) to score a total of 13 items, meaning the minimum score would be 13, indicating low feasibility, and the maximum score would be 91, indicating high feasibility. The findings will be reported descriptively.
Semi-Structured Interview
Time frame: Collected at the end of the intervention (Week 4).
A semi-structured interview will ask participants for their perspectives on the intervention. The data will be reported qualitatively.
17 secondary outcomes
Session Time
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Distance Travelled
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Asymmetry Output
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Time Off Motor Support
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Energy
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Power
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Velocity
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Standing and Walking Assessment Tool (SWAT)
Time frame: Collected at baseline and at the end of the intervention (Week 4).
Berg Balance Scale
Time frame: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
Modified Timed-Up-and-Go
Time frame: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
10 Meter Walk Test
Time frame: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
Six Minute Walk Test
Time frame: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
Activities-specific Balance Confidence Scale
Time frame: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
Manual Muscle Testing
Time frame: Collected at baseline and at the end of the intervention (Week 4).
Grip Strength
Time frame: Collected at baseline and at the end of the intervention (Week 4).
Graded Redefined Assessment of Strength, Sensibility, and Prehension
Time frame: Collected at baseline and at the end of the intervention (Week 4) as appropriate.
Spinal Cord Independence Measure
Time frame: Collected at baseline and at the end of the intervention (Week 4).
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD) underlying the results reported from this study may be shared with qualified researchers for research purposes. Data will be shared only after appropriate de-identification, consent obtained, and in accordance with institutional research ethics, privacy, and data-sharing requirements. Supporting study documentation may also be made available where appropriate.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Spinal Stimulation, Inpatient SCI Physiotherapy and Inpatient SCI Occupational Therapy in people with Spinal Cord Injuries (Complete and Incomplete) and Spinal Cord Injuries (SCI), run by Janelle Unger 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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?
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 Janelle Unger, PhD (519-646-6100 ext. 45789, janelle.unger@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: During study enrolment). The study lists 6 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 27 Oct 2026.