A new treatment developed by Belgian neurologists was reported to help patients with chronic refractory cluster headaches. The name cluster headaches originates from the fact that headaches occur in clusters, typically once a year for a period of a month or two, during which headaches occur daily. Unfortunately, in some patients cluster headaches are chronic and occur continuously. Some of these chronic cluster patients respond to medications, such as verapamil, topiramate, lithium or Botox injections. A small number of patients fails to respond to any of the usual therapies and are considered refractory to treatment. Because the pain of cluster headaches is extremely severe and because headaches occur daily and often more than once a day these patients often become despondent. Out of desperation, doctors have tried different unproven and at times risky treatments, such as deep brain stimulators with electric probes implanted deep into the brain. This is obviously a very invasive procedure that has resulted in strokes and deaths. I have treated two patients with a much less invasive Vagus Nerve Stimulator and these two responded well.
Dr. Jean Schoenen and his colleagues implanted 28 patients with chronic refractory cluster headaches with a miniature neurostimulator implanted in the back of the nasal cavity, near the sphenopalatine ganglion. This ganglion has been injected and anesthetized (with lidocaine and cocaine) in an attempt to relieve various pains for many years. The stimulator was implanted by a neurosurgeon in an out-patient visit and the procedure leaves no visible scar. Once implanted, the device can be activated by a remote controller which the patient holds near the face. The study was blinded in that some patient were given either very mild or no stimulation at all. The researchers hoped that by stimulating sphenopalatine ganglion for 90 seconds patients would be able to stop a cluster attack. The results showed that only 7 (25%) of patients were able to abort an attack, but surprisingly another 10 (36%) reported that after trying to treat 30 attacks (over 3 – 8 week period) the frequency of their attacks dropped by more than 50%. Headache-related disability improved in 64% of patients. Patients were allowed to use acute medications to stop individual attacks and only 31% of those who received real stimulation used them, while these drugs were used by 78% of those given mild or no stimulation. The most common side effect was an unpleasant sensation in the face, experienced by 81% of patients but these symptoms resolved within 3 months. Two patients had infections and another two had their stimulator drift out of place and had to have it removed. The stimulator is known as ATI Neurostimulator System and it does not preclude having MRI scans done in these patients. The manufacturer of this device launched a large multi-center trial of this device in Europe, both for chronic cluster and disabling migraine headaches.
