Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury with Deep Brain Stimulation

This project is a study of electrical deep brain stimulation as a method for treating pain and autonomic dysreflexia in patients with chronic spinal cord injury. It is collaboration between the University of Miami and the Miami Veterans Administration Hospital. The first year was mainly taken up with obtaining regulatory approval. In the second year and third year report year, four subjects were enrolled, with one later withdrawing. Best pain relief in both completed subjects was given by a very low pulse rate, which is a new finding for this therapy. Pain changed for up to several days when new stimulation parameters were set, suggesting that that frequent pain assessment is need to correctly titrate stimulation parameters. Visual side-effects were the only observed complication of stimulation, but they disappeared when a very low, maximally analgesic pulse rate was set. Thus this therapy is not only more effective at lower pulse rates, it is also safer. No serious adverse effects have been observed. Protocols FDA and IRB were modified to extend study of each subject for 2 additional years funded by other sources, and to use a device PCS that additionally allows recording from electrodes for added information. A no-cost extension year is in progress.