Interim results from a post-market study for the Pulsante Microstimulator, a device that stimulates the sphenopalatine ganglion in the face, shows that 68% of cluster headache patients respond to the therapy.
Severe headache is a debilitating neurological condition that prevents sufferers from fully enjoying life, work, and time with family and friends. One type of severe headache is the cluster headache, characterized by intense pain around one eye, droopy eyelids, tears, and social withdrawal. Cluster headaches affect more than 375,000 people in the U.S. and are often described as ‘suicide headaches’ due to the excruciating pain experienced by patients. At present, there is no cure for cluster headaches, but specialists believe that the sphenopalatine ganglion (SPG), a facial nerve bundle behind the nose, is critical to the cluster pain pathway.
Autonomic Technologies, a San Francisco-based medical device company, has developed an electroceutical therapy called the Pulsante Microstimulator for the treatment of chronic cluster headaches. It is composed of a mini stimulator and lead that is surgically inserted into the upper gum near the SPG bundle on the side of the face with pain. Stimulation is controlled by the patient using a hand-held remote controller with individualized therapy settings adjusted by their physician. At the onset of an attack, the remote control is turned on and positioned over the cheek with the inserted microstimulator. Its removal from the cheek turns the controller off.
Interim results from a recent post-market study (Pathway R-1) examining the safety and efficacy of the Pulsante Microstimulator one year following insertion found that 68% of patients responded to the therapy. Patient therapeutic response was defined as a reduction of acute attacks by half, reduction of attack frequency by half, or both. In frequency responders, attack frequency was reduced by 88%, while acute responders experienced effective therapy in 86% of attacks. An overall reduction in acute medication used to treat attacks was observed at 52%. These results were similar to an earlier 2016 study published in Cephalagia where the Pulsante Microstimulator was shown to provide effective pain relief for 60% of patients over the course of 2 years, demonstrating the device’s success in managing cluster headaches.
The Pulsante Microstimulator U.S. clinical trial (NCT02168764) primary endpoint is set for January 2017. This innovative device is also CE marked for the treatment of cluster headache in Europe.
Written By: Fiona Wong, PhD