An interventional study of Transcutaneous Spinal Stimulation and Inpatient SCI Physiotherapy in Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI) and Spinal Cord Injuries and Disorders (SCI/D), sponsored by Janelle Unger. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Janelle Unger · Not applicable, Interventional, and Treatment
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 15 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →This is the only study on the registry with Janelle Unger as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Transcutaneous Spinal Stimulation · Other: Inpatient SCI Physiotherapy · Other: Inpatient SCI Occupational Therapy
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.
Device: Transcutaneous Spinal Stimulation · Other: FES Cycling
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.
Also known as: Transcutaneous Spinal Cord Stimulation, TSS, TSCS
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.
Also known as: Conventional Physiotherapy, Conventional Physical 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.
Also known as: Conventional Occupational Therapy
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.
Also known as: Functional Electrical Stimulation Cycling
Recruitment Rate
The number of participants that consent given the number of potential participants that are approached about the study, expressed as a percentage.
Time frame: During study enrolment
Intervention Adherence
The number of intervention sessions attended by participants compared to the anticipated number of sessions, expressed as a percentage.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Collected at the end of the intervention (Week 4).
Session Time
Time spent in each session, along with time using TSS. Measured in minutes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Collected at baseline and at the end of the intervention (Week 4).
Grip Strength
For participants in inpatient rehabilitation, measured in kilograms.
Time frame: 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.
Time frame: 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.
Time frame: Collected at baseline and at the end of the intervention (Week 4).
Transcutaneous Spinal Stimulation Parameters - Pulse Width
The pulse width used during the intervention, measured in microseconds.
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Transcutaneous Spinal Stimulation Parameters - Pulse Frequency
The pulse frequency used during the intervention, measured in Hertz (Hz).
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Transcutaneous Spinal Stimulation Parameters - Intensity
The stimulation intensity used during the intervention, measured in milliamps (mA).
Time frame: Collected throughout the intervention period with final reporting at the end of the intervention (Week 4).
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 4 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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