Feasibility of Transcutaneous Spinal Stimulation in Rehabilitation

Trial details

Who runs it

Janelle Unger

Trial code

NCT07898150

Record updated

27 October 2026

Original description

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.Read full original descriptionShow less

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.

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.

Inclusion: 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.

Exclusion: 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; Experiencing progressive worsening of symptoms related to their SCI; 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.

ClinicalTrials.gov NCT07898150