Clinical Trials

The HEMO Trial will implant 4 participants with chronic (>12 months) spinal cord injury located between C3 and T6 who have confirmed severe orthostatic hypotension and autonomic dysreflexia. The purpose of this study is to stimulate the circuits in the spinal cord that are directly responsible for hemodynamic control to restore hemodynamic stability. The ultimate objective of this study is to provide preliminary safety and efficacy measures on the ability of the hemodynamic Targeted Epidural Spinal Stimulation (TESS) to ensure the long-term management of hemodynamic instability and reduce the incidence and severity of orthostatic hypotension and autonomic dysreflexia episodes in individuals with chronic cervical or high-thoracic spinal cord injury. In addition, the long-term safety and efficacy of TESS on cardiovascular health, respiratory function, and quality of life in participants with chronic spinal cord injury will be evaluated.

In almost all clinically-complete injuries there are some preserved connections across the site of injury, but these connections are not functional in a normal state (i.e., dormant). With the application of electrical current to the nervous system circuits within the spinal cord below the level of injury, we are able to re-awaken these dormant connections. This functional re-connection allows for the brain to recover some of the lost control over systems below the level of injury. Furthermore, the spinal cord is not simply a relay pathway (i.e., highway) transmitting information from the brain to the periphery. It also contains intricate interconnections that can process information and coordinate outputs with little input from the brain. Stimulation also helps to re-awaken these complex interconnections. Together, the awakening of dormant pathways and activation of complex interconnections with stimulation often leads to meaningful improvements in function for people with spinal cord injury. We are harnessing these concepts to provide health solutions for people with spinal cord injury.