St. Jude (STJ) Reports Encouraging Data from PNS Study on Optical Nerve for Migraine Management

St. Jude Medical, Inc. (NYSE: STJ) reports study results on the safety and efficacy of peripheral nerve stimulation (PNS) of the occipital nerve for the management of pain and disability associated with chronic migraine.

Presented at the 15th International Headache Congress in Berlin, Germany, the study shows statistically significant improvement across multiple measures including a reduction in the number of headache days per month and improvement in quality of life. This is the largest clinical study to date evaluating the use of PNS via an implanted medical device for the treatment of chronic migraine.

The study followed 157 participants who, on average, suffered from headache 26 days per month. Study participants were implanted with the St. Jude Medical Genesis™ neurostimulator and randomly assigned to an active or control group for 12 weeks. The active group received stimulation immediately upon implant, while patients in the control group did not receive stimulation until after the first 12 weeks. All patients were followed for one year. At one year, 66 percent of patients reported excellent or good pain relief.

At 12 weeks, the study demonstrated the following statistically significant results:

• Patients who received stimulation reported a 28-percent decrease in their number of headache days (seven less days a month) compared to the placebo group which reported a 4-percent decrease (one less day per month).
  
• Overall disability as measured by the Migraine Disability Assessment questionnaire (MIDAS) indicated participants in the active group had a 41-percent improvement compared to a 13-percent improvement in the placebo group.
  
• Zung Pain and Disability Index (PAD) scores improved in the active group by 20 percent compared to an 8-percent improvement in the placebo group.
  
• In addition to the standardized scales (MIDAS and PAD), patients were asked to subjectively assess their pain relief. The active group reported 42-percent pain relief compared to 17 percent in the placebo group.
  
• Patients in the study were asked to define their headache relief as excellent, good, fair, uncertain, or poor. At the 12-week end point, 53 percent of patients in the active group ranked their relief as excellent or good compared to 17 percent in the placebo group.
  
• When asked to rate the effect on their quality of life, 67 percent of the active group reported improvement compared to 17 percent in the placebo group.
  
• The active group reported 51-percent satisfaction with headache relief compared to 19 percent in the placebo group.

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