Clinical Experience

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.

Efficacy:

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)
Figure 1
Pain relief chart

“The efficacy data indicate that acute electrical stimulation of the SPG provides significant attack pain relief and in many cases pain freedom compared to sham stimulation”
Figure 2
Chart of Changes in cluster attach frequency

“… the reduction in CH attacks was clinically meaningful and merits further investigation”

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)

Figure 3
Clinically significant improvements in headache disability and quality of life

“Overall, SPG stimulation significantly improves quality of life in these very disabled patients”

Reduction in Medication Use:

Figure 4
Fewer Acute Medications Used With Full Stimulation vs. Sham (p<0.0001) reduction in medication use

Safety:

The Pulsante System was well tolerated. Adverse events are similar to those reported in other orofacial, surgical procedures.

WELL TOLERATED

“… an effective treatment option for CCH sufferers with an acceptable safety profile.”
  • 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.

*3 lead revisions: 2 leads originally placed within pterygopalatine fossa (PPF) but not proximate to SPG, 1 lead tip placed within maxillary sinus
**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.

 
© 2012-2015 Autonomic Technologies, Inc. All Rights Reserved. Last updated: 08 January 2015
CE Marked Intended Use: The Pulsante™ SPG Microstimulator System (ATI Neurostimulation System) is CE marked in Europe and is intended to relieve the acute pain of cluster headache. In some patients the use of the System has been associated with a reduction in the number of cluster headaches.
In the United States please note: Caution–Investigational device; limited by US law to investigational use.