HEMO Trial
Project Overview
Spinal cord injury (SCI) leads to dramatic alterations in physical and mental well-being. It is well understood that people with severe SCI lose their ability to move. However, a lesser-known consequence of SCI is the profound disruption to blood pressure (BP) regulation. People with SCI experience rapid fluctuations in their BP that lead to dizziness and nausea up to 40 times per day, greatly affecting their quality of life. In addition, these frequent fluctuations in BP contribute to an increased risk for stroke and heart disease, which is the most common cause of morbidity and mortality in people with SCI. Current management of BP lability is restricted to long-acting drugs that may only be sufficient in mild cases. We have shown that an implantable device can precisely regulate BP in preclinical models of SCI and in one patient with profound BP instability. This device consists of an electrode array that is surgically implanted over the region of the spinal cord that contains neural circuits involved in the regulation of BP and an implantable pulse generator that delivers electrical stimulation to these circuits to regulate BP. The aim of this project is to test the effect of stimulating this specific location of the spinal cord and study its effects on BP in people with severe SCI in their necks (cervical spine). This population experiences the worst disruption to their BP regulation and to their quality of life. We will also assess the long-term safety of this device and its effects on the cardiovascular and cardiorespiratory systems. We anticipate that this device will improve BP regulation and quality of life for all of the participants with SCI that are enrolled. Furthermore, the results of this research will inform the appropriate methodology for a large-scale clinical trial that will allow us to move this therapy along toward clinical indication.
Principal Investigator
Aaron Phillips , University of Calgary
Partners and Donors
Barbara Turnbull Foundation for Spinal Cord Research