ONSTIM Study Details:
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.
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Patients were randomized to three groups to receive: either
- a neurostimulator and have the ability to control the level of stimulation
- a neurostimulator as part of a device control group
- 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.
- Slippage of lead wires was the most common adverse event.
- In addition to evaluating the efficacy of ONS therapy, the ONSTIM trial was designed to follow patients out to three years related to safety.
Dr. Joel Saper, founder and director of the Michigan Head Pain and Neurological Institute, Ann Arbor, Mich., and principal investigator for the ONSTIM study, stated,
“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... 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.”3
Summary and Comments:
Early results of the ONSTIM trial look promising for patients with intractable Migraines and headaches. Additional ONS studies are ongoing, and their results are anxiously awaited.
Patients considering ONS treatment should be aware of some key points:
- ONS is not appropriate for all patients.
- Occipital nerve block injections may be a good predictor of whether OSN is suitable for individual patients.
- ONS is not yet FDA approved for Migraine and headache prevention, but may be prescribed off-label (as many medications are).4
- Since ONS is not FDA approved, most insurance companies will not pay for this treatment.4
- Some doctors are coding insurance forms for conditions other than Migraine or headache in order to get insurance company approval and payment. It should be noted that this is an illegal practice that could result with patients having an additional condition (that they don't have) listed on their medical records. If ONS is approved based on a condition the patient does not have, insurance companies can rescind payment and/or take legal action.4 A leading Migraine specialist who wishes to remain unnamed commented, "It's a sad state of affairs. A less trained doctor may misdiagnose a chronic Migraine patient as having another condition, say occipital neuralgia, and with that misdiagnosis, get the insurance company to pay for ONS. Another doctor may knowingly falsify the forms and list occipital neuralgia as the diagnosis to get ONS covered by the patient's insurance. Yet the doctor who correctly lists the diagnosis as chronic Migraine cannot get the insurance company to pay. It's a case where diagnosing correctly and completing the forums honestly results in the treatment not being covered by most insurance companies.5
