Geko<sup>TM</sup> system to predict peripheral nerve stimulation: reality or fantasy? A prospective pilot study

Peripheral nerve stimulation (PNS) is an established therapy for chronic pain refractory to conventional treatments. Wearable devices such as the gekoTM system, originally developed to enhance lower limb circulation, may have potential as non-invasive screening tools to predict PNS candidacy. The present prospective, uncontrolled pilot study aimed to evaluate the feasibility of using the gekoTM device for predicting responsiveness to implanted PNS in patients with refractory chronic pain. Twenty patients with refractory chronic pain were treated with low-frequency common peroneal nerve stimulation (1 Hz, 6 hours/day) for 10 consecutive days using the gekoTM device. Outcomes included Numeric Rating Scale (NRS) pain scores, quality of life (QoL), oxygen saturation index (SpO2), and patient satisfaction. The primary endpoint was defined as the proportion of patients achieving a reduction of ≥50% in NRS scores. Statistical significance was evaluated using paired t-tests (p<0.05). Treatment led to significant improvements in pain, SpO2, and QoL. Half of the patients achieved the primary endpoint, and no serious adverse events were reported. The satisfaction rate among completed cases was 100%. The gekoTM device shows promise as a non-invasive screening tool for PNS candidacy. These results should be interpreted cautiously, given the small sample size, lack of a control group, and exploratory design. Larger, controlled trials are warranted.