gms | German Medical Science

Objective: Cluster headache (CH) is a debilitating, severe form of headache. A novel non-systemic therapy has been developed that produces therapeutic electrical stimulation to the sphenopalatine ganglion (SPG). Our experiences with a transoral surgical technique for inserting the Pulsante SPG Microstimulator into the pterygopalatine fossa (PPF) are presented herein.

Methods: We implanted 5 CH pats so far, 3 females, 2 male. 2 out the total already received an ONS device with partial (30% seizure reduction) long-term effect. Technical aspects include detailed descriptions of the preoperative planning using computed tomography scans, 3D printouts of the individual skull base for presurgical digital microstimulator insertion into the patient-specific anatomy and intraoperative verification of microstimulator placement. Surgical aspects will be presented including techniques to insert the microstimulator into the proper midface location atraumatically

Results: 4 weeks after implantation stimulation was switched on, patients are asked to stimulate 15 minutes during the attacks. All patients benefit from surgery so far. The 2 combined ONS/SPG patients where almost free of attacks. The further 3 patients reported (preliminary 6- 8 weeks after OR) already an improvement including a reduction of attack duration and severity. One surgical complication occurred with misplacement of the electrode into the ethmoidal sinus. By using intraoperative CT this was immediately revised and ended in an accurate final electrode position. During the Pathway CH-1 and Pathway R-1 studies, 99 CH patients received an SPG microstimulator. Ninety-six had a microstimulator placed within the PPF during their initial procedure. Perioperative surgical sequelae included sensory disturbances, pain, and swelling. Follow-up procedures included placement of a second microstimulator on the opposite side (n=2), adjustment of the microstimulator lead location (n=13), re-placement after initial unsuccessful placement (n=1), and removal (n=5). This SPG microstimulator insertion procedure has sequelae comparable to other oral cavity procedures including tooth extractions, sinus surgery, and dental implant placement. Twenty-five of 29 subjects (86%) completing a self-assessment questionnaire indicated that the surgical effects were tolerable and 90% would make the same decision again.

Conclusion: SPG is safe and feasible. We hereby present the technique and preliminary personal results of this new approach for a debilitating disease. With an interdisciplinary team technical limits can easily be solved. Further studies are required regarding long-term efficacy of this promising method.