An interim analysis of registry data evaluating therapeutic response to neurostimulation from a device for treating cluster headaches demonstrates the effectiveness of the therapy, according to discussion during poster sessions of the 58th Annual Scientific Meeting of the American Headache Society on Friday in San Diego.
Cluster headache (CH) is a disabling neurological condition characterized by intense stabbing pain, often accompanied by swelling, tears, and nasal congestion. The pain caused by cluster headaches is recognized as among the most severe pain documented. The Pulsante SPG Microstimulator System (ATI Neurostimulation System) was developed to treat patients with cluster headache by stimulating a nerve bundle behind the nose known as the sphenopalatine ganglion (SPG).
An interim analysis of post-market registry study (Pathway R-1) was conducted at 12 months following device insertion in CH patients to evaluate safety and long-term effectiveness of SPG stimulation. The Pathway R-1 analysis found that 68% (58/85) of patients were therapeutic responders, meaning they experienced either a reduction in attack frequency of at least 50 percent (frequency responders), effective therapy in at least 50 percent of the attacks that were treated (acute responders), or both.
Effective therapy was defined as relief from very severe, severe or moderate pain down to mild pain, or freedom from very severe, severe, moderate or mild pain, all without the use of acute pain medications.
“We were encouraged by the findings of this open-label registry study because it reaffirmed the effectiveness of SPG stimulation for cluster headache patients, producing outcomes in the population that are consistent with the original outcomes in the randomized-controlled study,” Rigmor Jensen of the Danish Headache Centre, University of Copenhagen, Glostrup, Denmark, reported.
The study also found that attack frequency was reduced by 44 percent in the population (p < 0.0001), with frequency responders experiencing an 88 percent reduction. Acute effective therapy was achieved in 39 percent of attacks treated in the population, with acute responders achieving effective therapy in 86 percent of attacks.
In addition to changes in attack frequency and the percent of attacks achieving effective therapy, changes in the use of acute medications was evaluated. The population had a 52 percenet reduction of acute medication (p < 0.0001).
The occurrence of side-effects in this population was not different from previously published data, which typically included sensory disturbances, post-operative pain, and swelling. These symptoms were generally considered mild to moderate and resolved within 2-3 months.
The SPG neurostimulation therapy achieved CE Mark in Europe in 2012 and is currently under a clinical study sponsored by Autonomic Technologies, Inc., Redwood City, CA to evaluate its safety and effectiveness in the U.S. for the treatment of chronic cluster headache. Autonomic Technologies, Inc., with offices in Germany and Switzerland, is focused on the development and commercialization of therapies for the treatment of autonomic disorders, particularly severe headache.