St. Jude Medical, Inc., recently became the only manufacturer to receive the primary European regulatory acceptance, the European CE Mark of approval, for their implanted neurostimulation device for patients with intractable chronic Migraine. The Genesis TM neurostimulation method for peripheral nerve stimulation or PNS of the occipital nerve is used to help reduce the pain and disability associated with chronic Migraine.
Peripheral Nerve Stimulation therapy provides a mild electrical pulse to the occipital nerves with small electrical leads. These lead(s) are placed under the skin in the back of the head, in the occipital area, and connected to a neurostimulator which feeds the pulses. The neurostimulator, a pacemaker type of device, is placed in the lower portion of the back has been successful for a number of patients.
The European CE Mark of approval, which is the European equivalent of FDA approval in the United States, stemmed from one of the biggest clinical studies completed. It was a double-blinded, randomized controlled study with 157 participants. Some of the tools used in the study included the Migraine Disability Assessment or MIDAS questionnaire, patient diaries and personal evaluations. Questions asked during the study included their Migraine severity, frequency, length and medication usage. Here are some details after 12 weeks:
- patients in the active group (with PNS) had seven less Migraine days according to the MIDAS questionnaire as opposed to a reduction of only one less Migraine in the control group
- MIDAS scale disability for the active group showed a 41% improvement after 12 weeks in the active group as opposed to only a 13% improvement in the control group.
At the one-year mark. the results were even more interesting:
- 88% of participants would recommend PNS to someone else
- 68% of participants said their quality of life improved
- 67% of participants were very satisfied or satisfied with the procedure
- 65% of participants said they received excellent or good pain relief
"As professor and practicing neurologist who works with these patients on a daily basis, I see firsthand the challenges they face in trying to manage their pain and disability and how chronic migraine impacts their lives and their families," said Dr. Stephen D. Silberstein, director of the Jefferson Headache Center in Philadelphia, Pennsylvania. Dr. Silberstein was the primary investigator in this recent Migraine clinical trial with St. Jude Medical on chronic Migraine and was able to see the amazing "life-changing potential" this treatment may offer for chronic Migraine patients.1
Chronic Migraine is defined as having 15 or more headaches or Migraine attacks a month, eight of which must be Migraines. The International Headache Society's International Headache Classification of Headache Disorders (ICHD-II) lists chronic Migraine under complications of Migraine 1.5.1. Although it's not included in the ICHD-II criteria, regulatory criteria for chronic Migraine used by the FDA and the European regulatory officials add that the Migraines must last at least four hours each without treatment.