We have accumulated clinical results in over 80 patients in both the USA and Australia with results confirming both the ability to measure nerve signals and closed loop feedback are robust.
Current Clinical Trials
We are currently sponsoring an IDE approved study in the USA to assess closed loop feedback in an extended acute trial. For details about the trial, please click here
For details about approved trial to assess feedback control in Australia please click here
Completed Early Clinical Trials using Temporary Devices
Automatic Control of Spinal Cord Stimulation (2014)
The goals of the study included evaluation of changes in various outcome measures such as pain scales, patient satisfaction, quality of life, paresthesia descriptors, and implant procedure time and comparison of the use of feedback and non-feedback SCS in an acute setting. The overwhelming majority of patients completing the trial showed improved pain relief and reduced side effects relative to conventional stimulation.
Automatic Control of Spinal Cord Stimulation (2012)
The purpose of this study was to collect ECAP data from patients implanted with externalized commercial SCS leads. This data was used to determine the feasibility of reliably recording ECAPs and using those signals as a control variable in a closed loop feedback controlled system. To date, 39 patients have enrolled in the study. The study further established that ECAPS can be reliably measured and demonstrated the use of feedback control to reduce uncomfortable side effects.
Recording and Measurement of Evoked Spinal Cord Potentials (2012)
The study was performed to record signal responses from the spinal cord due to electrical stimulation in an adjacent area of the spinal cord with electrodes on the same electrode array. A total of 5 patients diagnosed with chronic pain and undergoing the implantation of a trial SCS lead to determine their suitability for SCS to treat their pain were enrolled. This study established that ECAPs can be recorded in humans with chronic pain and that the fibers being recruited during SCS are Aβ sensory nerve fibers. In addition, the amplitude of the ECAP signal was found to correlate with the degree of coverage of the painful area.