Clinical Research Directory

Feasibility of Transcutaneous Spinal Stimulation in 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.

Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia

This case-control study aims to investigate left ventricular remodeling in individuals with chronic spinal cord injury or disease (SCI/D) (≥10 years) and autonomic dysreflexia (AD) who have no prior cardiovascular history. The primary objective is to compare cardiac changes between 24 individuals with high-level SCI/D (above Th6) who have AD and 24 individuals with low-level SCI/D (below Th10) who do not have AD. A secondary objective examines how factors such as age, sex, injury duration, and physical activity are associated with cardiac remodeling. All 48 participants will undergo cardiac MRI as well as blood measurement of B-type natriuretic peptid to assess cardiac morphology and function. The findings could shed light on a potentially underestimated cardiovascular risk factor in the SCI/D population.

Motoneuron Recruitment and Motor Evoked Potential Up-Conditioning (MEP) in Spinal Cord Injury (SCI)

The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections. Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Spinal cord injury causes damage to the brain-to-muscle connection. However, when the injury is "incomplete", there is a possibility that some of the brain-to-muscle pathways are still connected and may be trained to improve movement function. For examining brain-to-muscle pathways, investigators use a transcranial magnetic stimulator. Investigators hope that the results of this research study will help us develop new treatments for people who have movement disabilities. This study will require about 42 visits over the first 14 weeks, and another 6 visits over an additional 3 months. Each visit will take about 1 ½ hours.

Using Non-invasive Brain and Spinal Cord Stimulation to Improve Arm and Hand Function After Spinal Cord Injury

Cervical spinal cord injury (SCI) disrupts communication between the brain and spinal circuits, affecting voluntary movement control and contributing to arm and hand impairments, the top recovery priority for people with tetraplegia. Although rehabilitation and emerging neuromodulation approaches can support meaningful gains, many individuals experience persistent limitations in reaching and grasping. Current noninvasive stimulation strategies typically target the brain OR the spinal cord alone, despite strong reciprocal interactions between these structures. Cervical transcutaneous spinal cord stimulation (tSCS) can enhance upper limb function. Cerebellar stimulation, given its key role in sensorimotor integration and modulation of corticospinal excitability, represents a promising but underexplored therapeutic target. Theta burst stimulation (TBS), a rapid form of repetitive transcranial magnetic stimulation (TMS), induces lasting changes in cortical excitability and may promote associative plasticity when paired with spinal cord stimulation. This double-blind, randomized, sham-controlled pilot trial (n=24) will evaluate the feasibility, preliminary efficacy, and mechanisms of combined cerebellar TBS + cervical tSCS in people with chronic cervical SCI (AIS B, C or D). Participants will either receive cerebellar TBS + cervical tSCS, tSCS only, or sham stimulation while engaging in functional task practice such as pinching and grasping 3x/week for 8 weeks. Feasibility outcomes include adherence, retention, and safety. Efficacy will be assessed using the GRASSP strength sub-score and KINARM-based measures of sensorimotor control. Mechanistic outcomes will assess changes in cortical and spinal cord functional connectivity using resting state fMRI, corticospinal excitability using motor evoked potentials, and spinal excitability using the H reflex. Findings will establish whether combined cerebellar TBS and cervical tSCS is feasible, safe, and capable of enhancing upper limb recovery.