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Medtronic releases data on benefits of new neurostimulation system

Medtronic : 26 June, 2008  (Company News)
Medtronic has announced that data from a multi≠centre, prospective, randomised, single≠blinded, controlled investigational study using the company’s neurostimulation system to stimulate the occipital nerves as a potential approach to treating medically refractory chronic migraines is to be presented at the annual scientific meeting of the American Headache Society (AHS) in Boston, USA.
The study, called Occipital Nerve Stimulation for the Treatment of Intractable Migraine (ONSTIM), included patients who have regularly experienced 15 or more headache days per month that were not responsive to conventional medical therapies.

The ONSTIM study, sponsored by Medtronic and conducted under an investigational device exemption (IDE), collected electronic diary data from 66 patients from nine centres who were followed for three months. The data to be reported at the AHS meeting include the average change in the number of headache days per month, overall pain intensity and the responder rate based on at least a 50 percent reduction in headache days per month or at least a three≠ point reduction in overall pain intensity.

“The ONSTIM results suggest that occipital nerve stimulation, or ONS, may be a promising therapy option for individuals who have not had success in treating their chronic migraine and as a result are living with the painful and often debilitating symptoms,” said Dr Joel R Saper, MD, founder and director of the Michigan Head Pain and Neurological Institute, Ann Arbor, Michigan, and principal investigator for the ONSTIM study. “While ONS for chronic migraine requires additional clinical evaluation, our early experience in this study is encouraging and indicates that ONS could possibly help some chronic migraine patients who have exhausted other treatment options.”

In the study, thin lead wires were placed under the skin near the occipital nerves, which arise from the spinal cord and branch out across the back of the head carrying sensory signals from that region to the brain. The leads were connected to an implanted Medtronic neurostimulator that delivered controlled electrical pulses to the occipital nerves.

Patients were randomised to three groups to receive: either a neurostimulator and have the ability to control the level of stimulation; or a neurostimulator as part of a device control group; or only standard medical management instead of an ONS implant. A positive response was defined as at least a 50 percent reduction in the number of headache days in a month, or a reduction in the pain intensity of at least three points on a standard 0≠10 pain scale. In addition to evaluating the efficacy of ONS therapy, the ONSTIM trial was designed to follow patients out to three years related to safety. “We are pleased to be the first to present randomised, controlled data on ONS for intractable chronic migraine, where there is a large unmet medical need not currently addressed by medication or other therapies,” said Richard E Kuntz, MD, corporate senior vice president and president of the Neuromodulation business at Medtronic. “We plan to apply our expertise and long≠standing history in neurostimulation for chronic pain to pursue additional studies of the ONS approach for those who suffer from these persistent and highly debilitating migraines.”

Medtronic has experience in developing viable treatment options for thousands of people who suffer from chronic pain. Other Medtronic neurostimulation technologies already have gained significant medical acceptance for the management of symptoms of chronic back and leg pain, deep brain stimulation for the treatment of Parkinson’s disease and essential tremor and sacral nerve stimulation for the treatment of the debilitating symptoms of overactive bladder.
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