BurstDR Spinal Cord Stimulation Versus Sham in Established Responders

BurstDR spinal cord stimulation is a paresthesia-free neuromodulation therapy used for the treatment of chronic pain. Although clinical studies have demonstrated beneficial outcomes with BurstDR therapy, the specific contribution of ongoing stimulation, separate from contextual effects, expectation, natural symptom variation, and other nonspecific influences, remains incompletely defined.

This study uses a randomized, double-blind, two-period crossover design in patients who are already implanted with a spinal cord stimulation system and have an established clinical response to BurstDR therapy. Studying established responders avoids potential confounding associated with implantation, postoperative recovery, and initial programming and optimization, and allows the effect of ongoing stimulation to be evaluated under controlled conditions.

Before the randomized treatment periods, each participant will complete a baseline observation under their established active BurstDR settings, followed by a washout period with stimulation switched off. Participants will then undergo two randomized treatment periods: one with active BurstDR stimulation and one with sham stimulation, separated by a second washout period. The order of the two conditions will be randomly assigned, allowing each participant to serve as their own control and thereby reducing the influence of between-patient variability.

During the active condition, stimulation will be delivered using the participant's established clinically effective BurstDR program. During the sham condition, stimulation output will be switched off while study procedures, participant contacts, and data collection will otherwise remain comparable between conditions.

Because BurstDR stimulation is intended to be paresthesia-free, it provides an opportunity for blinded comparison with sham stimulation. Before the randomized treatment phase, a standardized perceptibility assessment will be performed to confirm that participants cannot reliably perceive whether stimulation is active. Device access and information that could reveal treatment allocation will be restricted, and treatment programming will be performed by designated study personnel who are not involved in outcome assessment or the primary analysis.

The crossover and washout design is intended to minimize residual stimulation effects and provide a controlled assessment of the specific contribution of ongoing BurstDR therapy in patients who have previously demonstrated clinical benefit from this treatment.