Peripheral Nerve Stimulation Reduced Chronic Craniofacial Pain in RCT

Treatment with the Freedom Peripheral Nerve Stimulation (PNS) System (Curonix, Pompano Beach, FL) significantly reduced chronic craniofacial pain in a multicenter, randomized controlled clinical trial, which provided Level I evidence for the device’s use. Published in Pain Physician, the study was the first Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial to test the PNS system in craniofacial neuropathic pain, a condition with limited durable treatment options.

The trial included 60 participants with refractory craniofacial neuropathic pain across 7 US sites. All participants underwent permanent implantation of the Freedom PNS device targeting trigeminal or occipital nerves. After a 1-week therapy assessment, responders were randomized to either continue stimulation (active arm) or have the system deactivated for 3 months (control arm). Subsequently, the control group was reactivated, and all patients were followed for an additional 12 months. The primary efficacy end point was the proportion of participants with significant (≥50%) pain relief. 

Key findings from the trial include the following:

• After the initial 7-day therapy assessment when both groups received active stimulation, significant pain relief was reported by 56 of 60 participants (responder rate, 93%).
• At 3 months, significant pain relief was achieved in 69% of active arm group participants vs 11% of those in the deactivated, control arm group (P<.001).
• Active arm participants reported a 62% reduction in mean Visual Analog Scale (VAS) scores compared with 8.5% in controls; the VAS is method for measuring the continuum of pain intensity.
• Quality-of-life, patient global impression of change (PGIC), and pain interference scores all improved significantly in the active arm.
• After 3 months, when active stimulation was administered to participants in the deactivated, control arm, these individuals reported reductions in pain similar to those in the active arm.
• No serious adverse events were reported; the most common nonserious event was localized implant-site pain.

Sources: Curonix LLC. Curonix publishes results for the first and only IDE PNS multi-center randomized clinical trial resulting in an FDA 510(k) expanded indication for treating chronic craniofacial pain. GlobeNewswire. Published October 2, 2025. Accessed October 3, 2025. https://www.globenewswire.com/news-release/2025/10/02/3160313/0/en/Curonix-Publishes-Results-for-the-First-and-Only-IDE-PNS-Multi-Center-Randomized-Clinical-Trial-Resulting-in-an-FDA-510-k-Expanded-Indication-for-Treating-Chronic-Craniofacial-Pain.html

Hayek, SM. Haider N, Viswanathan A, Desai M, Rosenberg J, Vanquathem NE. A prospective, randomized, controlled clinical trial of high-frequency electromagnetic coupling powered permanent peripheral nerve stimulator for the treatment of chronic craniofacial pain. Pain Physician. 2025;28(5):417-429.