Motor cortex stimulation for chronic neuropathic pain: results of a double-blind randomized study.

Motor cortex stimulation (MCS) via surgically implanted electrodes has been used as an off-label treatment for chronic neuropathic pain (cNeP) but its efficacy has not been fully established. We aimed to objectively study the efficacy of MCS and characterize potential predictors of response. In this randomised, double-blind, sham-controlled, single centre trial, we recruited 18 cNeP patients who did not adequately respond to conventional treatment and had a numerical rating pain scale (NRS) score ≥ 6. Patients were initially assigned to receive three months of active ("on") or sham ("off") stimulation in a double-blind cross-over phase. This was followed by a 3-month single-blind phase, and 6 months of open-label follow-up. A meaningful response in our trial was defined as a ≥ 30% or 2-point reduction in NRS scores during active stimulation. Using Bayesian statistics, we found a 41.4% probability of response towards "on" vs. "off" MCS. The probability of improvement during active stimulation (double-blind, single-blind and open label phases) compared to baseline was of 47.2-68.5%. 39% of patients were long-term responders, 71.4% of whom had facial pain, phantom limb pain, or complex regional pain syndrome. In contrast, 72.7% of non-responders had either post-stroke pain or pain associated with brachial plexus avulsion. 39% of patients had a substantial post-operative analgesic effect after electrode insertion in the absence of stimulation. Individuals with diagnoses associated with a good postoperative outcome or those who developed an insertional effect had a near 100% probability of response to MCS. In summary, we found that approximately 40% of patients responded to MCS, particularly those who developed an insertional effect or had specific clinical conditions that seemed to predict an appropriate postoperative response.