Nerve Stimulation an Effective Alternative Therapy for Hemicrania Continua

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Title: Nerve Stimulation an Effective Alternative Therapy for Hemicrania Continua
URL: http://www.pslgroup.com/dg/22E79E.htm
Doctor's Guide
October 9, 2008

SAN FRANCISCO -- October 9, 2008 -- A novel therapy using a miniature nerve stimulator instead of medication for the treatment of profoundly disabling headache disorders improved the experience of pain by 80% to 95%, according to a study published early online and appearing in the November 2008 issue of Lancet Neurology.

The findings give physicians the promise of a nondrug treatment option for pain sufferers unable to tolerate indomethacin.

"We need a range of treatments to offer patients whose lives are taken over by debilitating headaches," says Peter J. Goadsby, MD, Headache Center, University of California San Francisco, San Francisco, California.

"It's quite exciting to think about how technology will advance in the next 5 years to provide remarkable devices for the treatment of headache. Preventive approaches like these will completely change the landscape of headache treatment."

The study measured the effectiveness of nerve stimulation in 6 patients aged 37 to 64 years with hemicrania continua. At the beginning of the study, participants underwent a minimally invasive surgery to have the bion implanted at the occipital nerve.

Each participant then received continuous stimulation of the nerve for the first 3 months. The device was switched off for the fourth month, ensuring that patients did not receive stimulation of the occipital nerve during that time, and switched on again at month 5.

Switching off the bion enabled researchers to measure whether the device, rather than the placebo effect, was responsible for pain modulation.

To test long-term safety and efficacy of nerve stimulation therapy, follow-up sessions with the patient, a researcher, and a device technician occurred once a month for 4 months.

Patients kept diaries at hourly intervals during waking hours, which included the use of a pain severity scale ranging from 1 to 10 points. Participants shared their diaries with researchers after the fifth month.

Researchers found that within a range of 6 to 21 months after implantation of the bion, 5 of the 6 patients reported sufficient benefit to recommend the device to other patients with hemicrania continua.

At long-term follow-up, 4 of the 6 patients reported substantial pain improvement at a level of 80% to 95% and 1 patient saw a 30% improvement. The other patient reported that his pain worsened by 20%.

Overall, the research team found that participants not only improved with the bion therapy, but their pain worsened when the bion was switched off during the fourth month. In addition, diary submissions revealed an overall reduction in the pain score of 5 to 8 points.

"The treatment of migraine and other chronic headache pain can be a considerable challenge to physicians. Not all patients can tolerate the appropriate medicines, and the side effects leave patients and doctors in a difficult position," notes Dr. Goadsby.

"We have the opportunity to afford a huge change in quality of life for these patients. The bion was well tolerated, and neuromodulation is proving an effective and safe option, particularly in cases when patients have difficulty stomaching indomethacin."

SOURCE: University of California, San Francisco

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