Clinical results from the Pathway CH-1 Study, a randomized, sham-controlled, multi-center European trial demonstrates that stimulation of the sphenopalatine ganglion (SPG) with the Pulsante™ SPG Microstimulator System is highly effective in aborting attacks in patients suffering chronic cluster headaches (CCH).1
This is the largest randomized, controlled neurostimulation study performed in chronic cluster headache. This study supports the pivotal role of the SPG in cluster headache pathophysiology and provides evidence that SPG neurostimulation is a promising new therapy for treating CCH patients.
Overall, 68% of patients experienced a clinically significant improvement: achieved pain relief in ≥ 50% of treated attacks, experienced ≥ 50% reduction in attack frequency, or both
- 67.1% of treated attacks achieved pain relief at 15 minutes, compared to 7.4% of sham treated attacks (p<0.0001) (Figure 1)
- Significant pain relief achieved at 15, 30, 60 and 90 minute time points with full stimulation compared to sham stimulation (p<0.0001) (Figure 1)
- Average number of cluster attacks per week reduced by 31% (p=0.005)
- 88% reduction in attack frequency in 43% of patients (Figure 2)
Headache Disability and Quality of Life:
- 64% of patients experienced clinically significant improvement in headache disability (HIT-6)
- 75% of patients experienced clinically significant improvements in quality of life (SF-36v2 physical and/or mental component scores)
Reduction in Medication Use:
Fewer Acute Medications Used With Full Stimulation vs. Sham (p<0.0001)
The Pulsante System was well tolerated. Adverse events are similar to those reported in other orofacial, surgical procedures.
- Sensory disturbance (81% of patients) localized to distinct areas innervated by branches of the maxillary nerve, similar in number, severity, and duration to those observed in other procedures
- 2 infections, resolved with antibiotics, none required explants
- 3 lead revisions*
- 2 explants**
Click here to see a list of publications on the Pulsante System.
**2 explants: 1 lead migration within the PPF within hours of implant, 1 implant completed with neurostimulator that was too long for the anatomy; lead migrated out of the PPF within weeks of implant
1 Schoenen J et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache. Pathway CH-1: A randomized sham-controlled study. Cephalalgia 2013.