Background and objectives: The SPG plays a primary role in the pathogenesis of pain and autonomic symptoms associated with primary headaches. Our objective is to analyze the results from the initial surgical experiences.

Methods: Patients were implanted with a miniaturized neurostimulator using a minimally invasive trans-oral technique under general anaesthesia. The neurostimulator, which consists of an integral lead, body and fixation plate, is implanted such that the distal lead is within the pterygopalatine fossa and the fixation plate is anchored on the zygomaticomaxillary buttress.

Results: Ninety patients have undergone implantation of the ATITM Neurostimulator. Surgeries have been performed by 14 surgeons; 97% of cases have resulted in successful implantation and no infections resulting in explants occurred. With experience, the absolute time and standard deviation of the surgical duration is reduced by a third. Typical post surgical adverse events were reported, including sensory nerve dysfunction and pain, in most patients. These surgical sequelae are typically mild and resolve within 90 days. These sequelae and their severities have decreased since the introduction of a new surgical instrument.

Conclusions: The initial experience with this procedure has shown an acceptable safety profile and risk-benefit profile for patients who suffer from severe, medically intractable headaches.