Pulsante SPG stimulation device (Autonomic Technologies Inc.)
25 January 2018. A device that stimulates a collection of nerves located behind the nose was shown in a year-long study to lower intensity and frequency of cluster headaches, a condition marked by repeating episodes of severe pain. Results of the study, conducted in Europe, testing a neurostimulation device made by Autonomic Technologies Inc. in Mountain View, California, appear in the 18 January issue of the Journal of Headache and Pain.
Cluster headaches, according to the Mayo Clinic, occur in cyclical patterns and inflict severe pain. The headaches often happen without warning, starting around one eye, but can radiate out to other regions of the face and head. Excessive tearing, swelling, redness, and sweating can also occur. The attacks occur up to 8 times a day, lasting from 15 minutes to 3 hours. Repeated bouts of headaches occur in patterns or clusters that can last weeks or months, followed by remission periods when no headaches occur for months or even years.
Cluster headaches are not life-threatening, but because they occur at random periods, they’re difficult to treat proactively. Many people with the disorder take triptans, a type of drug often prescribed for migraines, or oxygen when attacks occur to relieve the pain. Autonomic Technologies is developing another type of treatment it calls the Pulsante system that stimulates the sphenopalatine ganglion, or SPG, a bundle of nerves behind the nose. The SPG is closely associated with the trigeminal nerve, considered the main nerve in headache disorders.
Cluster headache patients using the Pulsante system first need to have a microstimulator electrode surgically implanted through the gum into the area of the SPG on the side of the face where cluster headaches usually occur. When a headache happens, the individual places a hand-held controller that looks something like a telephone handset on the cheek over the implanted electrode. The controller sends radio signals to the electrode that stimulates the SPG, and the individual continues to hold the controller against the cheek until the pain subsides. People with cluster headaches can also use the device to prevent an attack if they believe one is imminent.
The study, conducted largely in Germany, but also in Denmark and Austria, recruited 97 registered users of the Pulsante system to report on their use and experiences with the device, of which 85 completed the exercise. The researchers, from headache clinics in Denmark and academic labs in Germany, tracked participants for 12 months. The team did not recruit a comparison group.
The results show 78 of the 85 participants experienced chronic cluster headaches, while 7 participants reported less-frequent episodic headaches, with some 13,600 attacks documented by all participants during the study. After 1 year using the Pulsante system, two-thirds (68%) of participants reported either a reduction in the frequency of headache attacks or noticeable pain relief. Overall, participants experienced 43 percent fewer headaches,with most of the reductions occurring early in the 1-year period. Participants also reported less use of pain medications, less disability, and higher quality of life.
Most adverse effects from the device were associated with the implant surgery, such as post-operative pain and swelling, rated as mild to moderate, and resolved with in 3 months. Similar adverse effects were found in a randomized study of the system’s safety, reported in February 2016.
Autonomic Technologies is a spin-off enterprise from the Cleveland Clinic. The Pulsante system is approved for marketing in Europe for relief of cluster headache pain.
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