Boston Scientific’s OPTIMISE trial is a randomized, placebo-controlled study assessing occipital nerve stimulation as a novel approach to treating migraines by masking the pain.
Patients are given a programmable implant that stimulates the greater occipital nerve, a method that has shown promise in early studies for reducing pain associated with chronic migraine.
"By directly targeting the occipital nerve with neurostimulation, we are potentially able to offer patients an effective and relatively low-risk therapy," principal investigator Dr. Richard Lipton said in prepared remarks.
The Precision implant has the FDA’s investigation device exemption to under clinical testing, and the results of the OPTIMISE trial will be used to support "various regulatory approvals" for the pain management system. The 1st OPTIMISE patient was treated at Mercy Hospital in Springfield, Mo.
The OPTIMISE study is part of a growing trend in neurostimulation, where implanted electrical stimulators are under evaluation for treatment of Alzheimer’s disease, for assistance with appetite and weight-loss, for treatment of overactive bladder and severe anorexia.