I have had the privilege of working with some incredible research mentors over my career. Chief among them are some of my co-authors on this recent publication reporting results from the Biotronik BENEFIT-02 Study.
Free Full-text Link to Journal Article
We began the BENEFIT-02 journey in 2018 with the goal of understanding patients response to two variants of a new type of spinal cord stimulation (SCS) programming termed multiphase therapy. Multiphase is designed to distribute the electrical stimulus across a broad target area of the spinal cord by sweeping across multiple electrodes with each pulse without pausing for charge balancing. This differs from traditional SCS, which delivers its energy typically over a single bipole or skipped bipole. Multiphase therapy results in more broad spinal cord activation in animal studies using real-time functional ultrasound to detect changes in cord blood flow as a surrogate for activation as demonstrated in the cartoon below.
What did we do in this study? We implanted commercial SCS electrodes into patients with the intent of keeping them in place for 3 weeks for the protocol. Patients underwent a typical commercial trial for back and/or leg pain and were evaluated at the end of trial as usual. Then we connected the electrodes to a generator capable of multiphase therapy and tested two different multiphase therapies. Patients reported their pain scores and satisfaction scores in real time on a watch they wore, which gives us a lot of data points to analyze.
Patients treated with SCS trials did well for overall as well as for back and leg pain. There was an improvement noted for both groups compared to the commercial trials (which could have been any waveform). To me, this proves the concept of multiphase in a narrow, controlled population.
Where do we go from here? Multiphase therapy is now FDA-approved in the US and commercially available on the recently approved Biotronik Prospera device. The arbiter of truth for this therapy has to be long-term real-world outcomes. This device has unique remote monitoring and programming capabilities that adds to the validity and stringency of the data captured by their system. Only time will tell if this is a key to unlocking long-term outcomes in SCS.