Neuromodulation Through Spinal Cord Stimulation Restores Ability to Voluntarily Cycle After Motor Complete Paraplegia.

Abstract Epidural spinal cord stimulation (eSCS) of the lower thoracic spinal cord has been shown to partially restore volitional movement in patients with complete chronic spinal cord injury (cSCI). Combining eSCS with intensive locomotor training improves motor function, including standing and stepping, but many patients with cSCI suffer from long-standing muscle atrophy and loss of bone mineral density, which may prohibit safe implementation. Safe, accessible, and effective avenues for pairing neuromodulation with activity-based therapy remain unexplored. Cycling is one such option that can be utilized as an eSCS therapy given its low-risk and low-weight-bearing requirement. We investigated the feasibility and kinematics of motor-assisted and passive cycle-based therapy for cSCI patients with epidural spinal cord stimulation. Seven participants who underwent spinal cord stimulation surgery in the Epidural Stimulation After Neurologic Damage (E-STAND) trial (NCT03026816) participated in a cycling task using the motor assist MOTOmed Muvi 300. A factorial design was used such that participants were asked to cycle with and without conscious effort with and without stimulation. We used mixed effects models assessing maximum power output and time pedaling unassisted to evaluate the interaction between stimulation and conscious effort. Cycling was well-tolerated and we observed no adverse events, including in participants up to 17 years post-initial injury and up to 58 years old. All participants were found to be able to pedal without motor assist, which primarily occurred when stimulation and effort were applied together ( p  = 0.001). Additionally, the combination of stimulation and intention was significantly associated with higher maximum power production ( p  < 0.0001) and distance pedaled ( p  = 0.0001). No association was found between volitional movement and participant factors: age, time since injury, and spinal cord atrophy. With stimulation and conscious effort, all participants were able to achieve active cycling without motor assistance. Thus, our stationary cycling factorial study design demonstrated volitional movement restoration with eSCS in a diverse study population of cSCI participants. Further, motor-assist cycling was well-tolerated without any adverse events. Cycling has the potential to be a safe research assessment and physical therapy modality for cSCI patients utilizing eSCS who have a high risk of injury with weight bearing exercise. The cycling modality in this study was demonstrated to be a straightforward assessment of motor function and safe for all participants regardless of age or time since initial injury.