Neurologist Joel Saper, founder and director of the Michigan Headache & Neurological Institute in Ann Arbor, doesn't believe there's a panacea for chronic headache, but does offer hope in promising new treatments, including neuromodulation.
Saper presented the results of the first randomized controlled study of neuro-stimulator use at the North American Neuromodulation Society conference in late 2008 in Las Vegas, a few months after doing the same in Boston. The study, commissioned by Medtronic, a company that makes medical devices, tested a neurostimulation system for intractable migraines in 66 patients. The system is not FDA-approved.
Early data are positive, said Saper, a 65-year-old Ann Arbor resident who also serves as director of the inpatient Head Pain Treatment Unit at Chelsea Community Hospital.
Neuromodulation is defined by the North American Neuromodulation Society as the therapeutic alteration of the central, peripheral or autonomic nervous systems by means of implanted devices - typically stimulators or pumps that are used to manage chronic pain, movement disorders and epilepsy and assist in stroke recovery. Think of them as pacemakers for the brain.
For migraine, sub-occipital stimulation works like this: A wire is burrowed just under the skin and connected to a device implanted in the torso or chest. Leads from the wire provide mild electrical pulses to the brain's occipital nerve at the back of the skull.
"If you stimulate the occipital nerve, its signal goes into the neck/spinal cord area and can modulate or inhibit the perception of pain because you're intercepting a signal," Saper said.
Kathleen Godec of Marquette is happy with her peripheral nerve stimulator, which was implanted in November 2007 as part of a study conducted at Saper's institute. She is among 30-40 institute patients who've received a neuro-stimulator over the years, inside and outside of clinical studies.
Godec, 55, has suffered migraines since she was six years old, she said. A referral to the institute led to her involvement in the study, which was commissioned by Advanced Neuromodular Systems, now a part of St. Jude Medical, a manufacturer of implantable medical devices in Plano, Texas.
More than a year later, Godec said, her migraines are 80 percent under control. She doesn't even mind the jokes about being bionic.
A tiny device is implanted in her lower back, with leads up to her brain. Godec, a supervisor at a library at Northern Michigan University, operates the system remotely, but the only time she turns it off is when she's driving because she was told a "surge" could cause her to lose control of her car. She hasn't experienced a surge.
Nor has Godec had to go to the emergency room for IV infusions of drugs to kill the pain or reach for emergency medicines when she feels a migraine coming on.
"This is the first treatment I've tried that really works," she said. "The list of medications I've tried is extremely long. I've had this for 14 months and it's still doing very well."
The devices are costly - they can range up to $30,000 (including surgical implantation) - but Godec's is free because she is part of the clinical trial. She figures she'll be able to keep the neurostimulator indefinitely.
Godec is among an estimated 28 million Americans who suffer from migraines. The majority of those afflicted - 70 percent - are women, according to the National Headache Foundation. A wide-ranging survey by the NHF found that 90 percent of migraine sufferers cannot function normally when a migraine strikes.
The national Medtronic study, the first controlled study of the use of neuro-stimulation for migraine and for which Saper was lead investigator, grew out of a collaboration that took him to London, where he observed changes in the brains of five patients while the neuro-stimulators were operating. The brain scans showed that the parts of the brain that "turn off" pain were "lit up," he said.
But neurostimulation seems to help some patients dramatically and others, not at all, Saper said, cautioning that it is a treatment for patients who have not responded to traditional and alternative therapies.
"I think it's promising, but I don't want to overstate it," he said. The technology and surgical implantation techniques need refinement, he said, "but the basic, underlying neuroscience seems sound in both deep brain and superficial stimulation."
Neurostimulation for Migraine: A Study
A 3-month feasibility study that compared traditional treatment with sub-occipital neurostimulation in 66 migraine patients showed promising preliminary results in controlling the chronic condition.
In the study, which was conducted under an investigational device exemption (IDE) - the treatment is not FDA-improved - 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 nerve. Of the 66 study subjects, 17 did not receive the neurostimulators.
Patients were assessed on the change in the number of headaches they had each week, the intensity of the pain and how they responded overall to the electrical pulses delivered to the occipital nerve at the back of their heads.
The results: Forty percent of the patients with the implants experienced a 50 percent or more reduction in the number of days they had headaches and a 3-point reduction in overall pain intensity on a scale of 0-10.
Written by Julie Edgar, Michigan Business Review