Epidural Spinal Stimulation Enables Global Sensorimotor and Autonomic Function Recovery After Complete Paralysis: 1st Study From India.

While the loss of sensorimotor and autonomic function often occurs due to multiple trauma and pathologies, spinal cord injury is one of the few traumatic pathologies that severely affects multiple organ systems both upstream and downstream of the injury. Current standard of care therapies primarily maintains health and avoids secondary complications. They do not address the underlying neurological condition. Multiple modalities including spinal neuromodulation have shown promise as potential therapies. The objective of this study was to demonstrate the impact of activity-based neurorehabilitation in presence of epidural spinal stimulation to enable simultaneous global recovery of sensorimotor and autonomic functions in patients with complete motor paralysis due to spinal cord injury. These data are unique in that it quantifies simultaneously changes multiple organ systems within only 2 months of intense activity-based neurorehabilitation when also delivering epidural stimulation consisting of sub-motor threshold stimulation over a period of 12-16 hours/day to enable 'self-training' in 10 patients. Finally, these studies were done in a traditional neurorehabilitation clinical in India using off-the-shelf electrode arrays and pulse generators, thus demonstrating the feasibility of this approach in simultaneously enabling recoveries of multiple physiological organ systems after chronic paralysis and the ability to perform these procedures in a standard, well-controlled clinical environment.

Epidural electrical spinal cord stimulation of the thoracic segments (T2-T5) facilitates respiratory function in patients with complete spinal cord injury.

INTRODUCTION: Patients with high cervical Spinal Cord Injury (SCI) usually require mechanical ventilation support. Phrenic Nerve Stimulation (PNS) both direct and indirect is the main alternative for these patients to wean off ventilator although PNS has several limitations and phrenic nerve could be also damaged after cervical spinal cord injury. OBJECTIVE: In this study, we assessed if the spinal cord Epidural Electrical Stimulation (EES) at the segments T2-T5, related to intercostal muscles, can facilitate respiratory function and particularly inspired tidal volume during mechanic ventilation. METHODS: Two patients with a high cervical injury were selected for this study with ethical committee permission and under review board supervision. A phrenic nerve conduction study with diaphragm electromyography (DEMG) was performed before and after trial of EES. RESULTS: Results demonstrate that EES at T2-T5 substantially increase the inspired volume. The results of this study also demonstrate that EES at spinal segments T2-T5 can bring patients dependent from mechanical ventilation to pressure support (on CPAP), preventing Baro-trauma and other complications related to mechanical ventilation. CONCLUSION: These findings suggest that tested approach applied alone or in combination with the phrenic nerve stimulation could help to reduce time on mechanical ventilation and related complications.

Transcutaneous Spinal Neuromodulation Reorganizes Neural Networks in Patients with Cerebral Palsy.

Spinal neuromodulation and activity-based rehabilitation triggers neural network reorganization and enhances sensory-motor performances involving the lower limbs, the trunk, and the upper limbs. This study reports the acute effects of Transcutaneous Electrical Spinal Cord Neuromodulation (SCONE™, SpineX Inc.) on 12 individuals (ages 2 to 50) diagnosed with cerebral palsy (CP) with Gross Motor Function Classification Scale (GMFCS) levels ranging from I to V. Acute spinal neuromodulation improved the postural and locomotor abilities in 11 out of the 12 patients including the ability to generate bilateral weight bearing stepping in a 2-year-old (GMFCS level IV) who was unable to step. In addition, we observed independent head-control and weight bearing standing with stimulation in a 10-year-old and a 4-year old (GMFCS level V) who were unable to hold their head up or stand without support in the absence of stimulation. All patients significantly improved in coordination of flexor and extensor motor pools and inter and intralimb joint angles while stepping on a treadmill. While it is assumed that the etiologies of the disruptive functions of CP are associated with an injury to the supraspinal networks, these data are consistent with the hypothesis that spinal neuromodulation and functionally focused activity-based therapies can form a functionally improved chronic state of reorganization of the spinal-supraspinal connectivity. We further suggest that the level of reorganization of spinal-supraspinal connectivity with neuromodulation contributed to improved locomotion by improving the coordination patterns of flexor and extensor muscles by modulating the amplitude and firing patterns of EMG burst during stepping.