Working at an academic medical center brings me into contact with exciting new developments across a wide range of medical fields. A few years ago, I was approached by Soma Sahai-Srivastava, MD, a renowned neurologist and Director of the USC Headache and Neuralgia Center. She had been asked to lead Keck Medicine of USC’s participation in a multicenter study of a nerve stimulation device to treat a condition called chronic cluster headaches. Cluster headaches are a severe type of headache that are sometimes called “suicide headaches” because of their severity and potential occurrence in cycles of multiple headaches lasting for weeks or months. There are many medical treatments, but they do not always work. Patients who do not respond to medical treatments often have few options.
A company called Autonomic Technologies, Inc. had developed a device to treat these headaches and funded a multicenter randomized, controlled trial approved by the US Food and Drug Administration (FDA). The treatment involved implantation of a small device in the cheek region, with the tip of it placed into an area called the sphenopalatine gangion. The system would treat the headache by having the patient place a handheld device over the implanted device when the headache was starting. This would trigger the implanted device to stimulate the nerves of the sphenopalatine ganglion. Many nerves connect to each other at the sphenopalatine ganglion, including nerves important in cluster headaches (as well as “ice cream headache” or “brain freeze”). Previous studies in Europe showed that stimulation of this area could improve cluster headaches and, perhaps, migraine headaches.
Autonomic Technologies reached out to Dr. Sahai-Srivastava, and I became involved as the implanting surgeon. The results of this randomized, double-blinded, placebo-controlled study were recently published in the medical journal Lancet Neurology, with the following study findings:
- Improved acute control of cluster headaches. Pain relief at 15 minutes after headache onset was 62% in the active treatment group vs. 39% in the control group. Freedom from pain at 15 minutes was 40% vs. 23%. Sustained pain relief at 1 hour after headache onset was 57% vs. 32%.
- Improved chronic control of cluster headaches. A greater proportion of study participants experienced a decrease in the frequency of cluster headaches. The greatest difference was in the proportion who had a 75% decrease in cluster headache frequency: 49% in the active treatment group vs. 24% in the control group.
- Good safety profile, with relatively few device- or treatment-related adverse events.
In spite of these promising results, the company did not secure FDA approval for sale in the United States. I am not aware as to whether these changes were felt not to be substantial enough, whether the FDA had concerns related to the study design, or whether there were other problems. For the patients in this country who did not have success with medications and who experienced substantial improvement in this debilitating condition, the hope is that another company will take up the work and move the technology forward.