Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache

Abstract

ObjectivesThe sphenopalatine ganglion (SPG) plays a pivotal role in cluster headache (CH) pathophysiology as the major efferent parasympathetic relay. We evaluated the long-term effectiveness of SPG stimulation in medically refractory, chronic CH patients.MethodsThirty-three patients were enrolled in an open-label follow-up study of the original Pathway CH-1 study, and participated through 24 months post-insertion of a microstimulator. Response to therapy was defined as acute effectiveness in ≥ 50% of attacks or a ≥ 50% reduction in attack frequency versus baseline.ResultsIn total, 5956 attacks (180.5 ± 344.8, range 2–1581 per patient) were evaluated. At 24 months, 45% (n = 15) of patients were acute responders. Among acute responders, a total of 4340 attacks had been treated, and in 78% of these, effective therapy was achieved using only SPG stimulation (relief from moderate or greater pain or freedom from mild pain or greater). A frequency response was observed in 33% (n = 11) of patients with a mean reduction of attack frequency of 83% versus baseline. In total, 61% (20/33) of all patients were either acute or frequency responders or both. The majority maintained their therapeutic response through the 24-month evaluation.ConclusionsIn the population of disabled, medically refractory chronic CH patients treated in this study, SPG stimulation is an effective acute therapy in 45% of patients, offering sustained effectiveness over 24 months of observation. In addition, a maintained, clinically relevant reduction of attack frequency was observed in a third of patients. These long-term data provide support for the use of SPG stimulation for disabled patients and should be considered after medical treatments fail, are not tolerated or are inconvenient for the patients.

Disability, Quality of Life, and Socioeconomic Burden of Cluster Headache: A Critical Review of Current Evidence and Future Perspectives

“…A summary of these studies and the main findings are reported in Table 3. In 6 of the longitudinal studies on refractory CCH patients 10,11,15,[24][25][26] and in 3 of the cross-sectional studies, 18,27,28 patients completed the Headache Impact Test (HIT-6). The Migraine Disability Assessment (MIDAS) was used in 2 longitudinal 10,11 and 1 cross-sectional study, 18 the Headache Disability Inventory (HDI) was used in 1 cross-sectional study, 29 and the Pain Disability Index (PDI) was used in 1 longitudinal study.…”

Neuromodulation for the Acute and Preventive Therapy of Migraine and Cluster Headache

“…The duration of the longest remission period experienced was 149 ± 97 (range 62‐322) days. By the end of the study period, 45% of patients had an acute response to SPG stimulation which in most patients was a consistent response pattern …”

“…By the end of the study period, 45% of patients had an acute response to SPG stimulation which in most patients was a consistent response pattern. 39 A second randomized control trial called the Pathway CH-2 Study was undertaken in the United States with a similar design to the Pathway CH-1 Study that was undertaken in Europe. Preliminary results from this clinical trial were recently made available.…”

Sphenopalatine ganglion stimulation induces changes in cardiac autonomic regulation in cluster headache

“…Both SPG stimulation responders and non-responders were included but all patients had postoperative CT scans verifying placement of stimulating electrodes in the sphenopalatine fossa. Details, including the definition of treatment response, can be found in the respective papers (Schoenen et al, 2013;J€ urgens et al, 2017). Data from the same sample as presented here are also presented elsewhere (Guo et al, 2017).…”