St. Jude Medical is touting results of a study of its Genesis neuromodulator for controlling serious migraines. 157 patients with an average of 26 days of headaches per month were implanted with the Genesis and compared to a control group that had the neurostimulator activated after 12 weeks.
Considering all the participants, after one year there was a reported good or excellent headache improvement in 66 percent of the implantees. Here are the findings from the initial 12 weeks as reported by St. Jude:
- 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.
Reuters is reporting that this might not be enough for the FDA to grant approval for this indication.