Aim: A new trans-oral surgical approach to the SPG has gained importance due to a new neurostimulation therapy for the treatment of CCH, which is in clinical trials currently. In our center, we have evaluated the morbidity of this approach for the treatment of CCH.

Methods: Patients meeting the criteria for CCH were implanted with a miniaturized neurostimulator using a minimally invasive trans-oral technique in the dorsal mid facial region as a part of either the Pathway CH-1 study or the Pathway CH Registry. All patients were implanted under general anesthesia with the use of intraoperative 3D CT imaging. Surgical follow-up examinations were performed to assess adverse events related to the surgical procedure for implanting the neurostimulator.

Results: 11 patients, 9 male and 2 female, with a mean age of 45 years of age, ranged 20–67 years of age with CCH were implanted with the ATI Neurostimulator. Most patients (10 of 11) experienced typical side effects from this type of surgery, including post surgical swelling and loss of sensation in the surgical area with an average time to resolution of 68.9 days, range 3–220 days, and 56.6 days, range 31–94 days, respectively. Three patients experienced neurostimulation revision procedures, two due to misplacement of the Neurostimulator lead and one due to lack of efficacy. Efficacy from the implanted ATI Neurostimulator has been very good, of the 7 patients that have been implanted for 1 year, 6 have responded to SPG stimulation. Three achieve pain relief in >50% of acute headaches and 3 experience a >50% reduction in headache frequency with SPG stimulation at one year.

Conclusion: The trans-oral surgical approach for implantation of the neurostimulator for SPG stimulation to treat CCH has surgical morbidity consistent with the morbidity reported for other trans-oral procedures.