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.

mSCI: Mobile Health App for Veterans With SCI and Caregivers

Caregivers of persons with Spinal Cord Injury (SCI) face increased risk of psychological distress, health problems, reduced quality of life, relationship strain, and restrictions in social and work participation. Military caregivers (Family Caregivers of wounded or disabled Veterans) reported similar negative effects of becoming a caregiver on their physical and mental health. Using results from our previous work in mHealth interventions for individuals with SCI, we developed a dual-target intervention for both individuals with SCI and their caregivers. The overall objective of this research study is to conduct translational research focused on adapting and tailoring the interactive Mobile Health and Rehabilitation (iMHere) 2.0 system to meet the needs of Veterans with SCI and their family caregivers, expanding the psychosocial intervention, and evaluating the feasibility of implementing the iMHere system among Veterans with SCI and their family caregivers.

EMG-Directed Virtual-Reality Training for Motor Stroke Rehabilitation

This study is testing whether rehabilitation using muscle activity signals can help improve arm and hand movement in people after stroke or spinal cord injury. In the main study, participants will use a virtual-reality feedback system that is controlled by surface electromyography (EMG). Surface EMG uses sensors placed on the skin to detect muscle activity. The feedback will help participants practise upper limb movements during rehabilitation. A related sub-study will run alongside the main study. In this sub-study, functional electrical stimulation will also be used to help activate muscles during training. The study will assess whether these rehabilitation approaches improve upper limb function. It will also explore whether changes in biological or movement-related markers are linked with recovery.

Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity

Muscle stiffness and muscle spasms are common after spinal cord injury. They can interfere with washing and dressing, moving between the bed and a wheelchair, walking, and sleep, and they can cause pain. Oral medications are the usual first-line treatment, but many people report limited benefit or side effects. This study examines a non-surgical method called transcutaneous spinal stimulation. Surface electrodes are placed on the lower back and on the abdomen, and an electrical current is passed between them to activate nerve fibers entering the spinal cord. Adults who have had a spinal cord injury and have muscle stiffness or spasms in the legs may participate. Each participant takes part in all parts of the study and serves as their own comparison. Participants attend four visits at one study site, about one week apart. The first visit is for consent and a clinical examination. At each of the next three visits, the participant receives one capsule containing tizanidine, baclofen, or an inactive substance (placebo), in an order assigned by chance. One hour later, the participant receives two 15-minute periods of spinal stimulation, one at 30 pulses per second and one at 75 pulses per second, also in an order assigned by chance. Neither the participant nor the person conducting the testing knows which capsule was taken. Leg reflexes, muscle activity, and knee movement are measured before the capsule is taken, one hour after it is taken, during each period of stimulation, and after each period of stimulation. Clinical scales for stiffness and spasms are also scored. The study compares the two stimulation rates, compares stimulation with each medicine given alone, and examines whether adding stimulation to a medicine has a larger effect than stimulation alone.

Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery

This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI). This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility. This study has two main goals: 1. To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury. 2. To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started. This study has two parts. In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel. In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.

The Impact of 'Digital Strolling' on Depression and Quality of Life of People With Severe Mobility Impairment

This intervention aims to develop and test the feasibility, acceptability, and preliminary effects of a "Digital Strolling" intervention among people with SMI. The intervention group will receive a "Digital Strolling" intervention, which consists of 20 minutes "Digital strolling" for 10 days, with lessons occurring once a day. The control group will receive passive observation of virtual walking videos only.

Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury

A well-established rehabilitation strategy for improvements of standing and walking ability in persons with spinal cord injury (SCI) is step training on a motorized treadmill with body weight support. A promising intervention is stimulation of the spinal cord through the skin (transspinal). No single intervention is likely to significantly improve long-term function after SCI on its own. Rather, combinatorial treatments that work synergistically and can be used at different clinical settings is the answer to target recovery in people with SCI. The objective of this clinical trial is to develop a non-invasive combinatorial intervention that can be used worldwide in different clinical settings. The investigators will use cervical and lumbosacral transspinal stimulation to augment the benefits of locomotor training and affect vital body functions after SCI. The investigators will deliver non-invasive cervical and lumbosacral transspinal stimulation alone or with step training to improve upright posture, walking, bladder, sex, and bowel function in persons with incomplete SCI. The noninvasive nature of the intervention holds minimal risk that outweighs the benefits.

Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia

The goal of this clinical trial is to learn more about how stimulating the nerves involved in sensation (either in the limbs or in the brain) can be used to restore sensation in participants who have a spinal cord injury. Participants in this study will have already been enrolled in the "Reconnecting the Hand and Arm to the Brain (ReHAB)" study, and received small electrodes in a part of the brain that is involved in sensing touch and pressure in the hand. The ReHAB study participants will also have received electrodes around the nerves in their arm. In this clinical trial, participants will receive two types of electrical stimulation: * Intracortical microstimulation (ICMS) which involves sending small electrical pulses to the part of the brain that processes sensation. * Peripheral nerve stimulation (PNS) which involves sending small electrical pulses to the nerves in the arm that transmit sensations from the hand. Researchers will try different patterns of stimulation for both ICMS and PNS and study how the participants perceive the sensations from the different stimulation patterns. The researchers will also study how combining ICMS and PNS affects the perceived sensations.

Spinal Cord Stimulation Combined With Motor Training in Non-Traumatic SCI: A Prospective Interventional Study

Interventional prospective longitudinal on the evaluation of spinal cord stimulation (SCS) assisted by motor rehabilitation training for restoring motor function in patients with non-traumatic spinal cord injury (SCI). The investigators will enroll ten research participants with clinically incomplete/complete SCI (patients with paraplegia or severe paraparesis) who will undergo SCS subsequently assisted by motor rehabilitation training for restoring motor function at IRCCS Ospedale San Raffaele, Milan, Italy. The main goal of the project is to evaluate the improvement in motor function generated by the combination of SCS and locomotor training. In line with recently published studies, the investigators propose that daily locomotor training in the presence of SCS with continuous stimulation parameters setting will enable the SCI individuals to stand and step independently while bearing full weight.