Sphenopalatine ganglion (SPG) neurostimulator placement for treatment of severe headaches using a trans-oral posterior maxillary approach

Pathway CH-1 Study: Sphenopalatine Ganglion (SPG) Stimulation for Acute Treatment of Chronic Cluster Headache (CCH) - Initial Experience (S36.002)

Objective: We aimed to investigate the safety and efficacy of SPG stimulation for the acute treatment of CCH. Background The pain and autonomic symptoms of cluster headache result from activation of the trigeminal parasympathetic reflex, mediated through the SPG. Design/Methods: A multi-center, dose range finding, multiple headache attack (HA), acute treatment study with random insertion of placebo has been initiated. All subjects meet the ICHD-II criteria for CCH with a minimum of 4 HAs/week. Subjects are implanted with a miniaturized neurostimulator which, along with a controller, provides SPG stimulation. Prior to the randomized period, stimulation parameters are adjusted in a titration …

Technical and surgical aspects of the sphenopalatine ganglion (SPG) microstimulator insertion procedure

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). A transoral surgical technique for inserting the Pulsante SPG Microstimulator into the pterygopalatine fossa (PPF) is presented herein. Technical aspects include detailed descriptions of the preoperative planning using computed tomography or cone beam computed tomography scans for presurgical digital microstimulator insertion into the patient specific anatomy and intraoperative verification of microstimulator placement. Surgical aspects include techniques to insert the microstimulator into the…

Stimulation of the sphenopalatine ganglion (SPG) for cluster headache (CH)-/INS;pathway CH-1 — /INS;Effectiveness and quality of life through 18 months