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 …

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