A Novel, Completely Head-Based Neurotechnology to Treat Chronic Migraine: Surgical Technique and Considerations

Introduction: The treatment of chronic migraine via implantable neuromodulation technologies has previously shown promising clinical results. Most commonly, neurostimulation leads bilaterally target the occipital nerve (ON), with or without supraorbital nerve (SON) leads to add additional anatomical coverage. Historically, systems designed for spinal cord stimulation have been utilized for these purposes, with several device performance issues being reported such as lead migrations and fractures.

Methods: A fully implantable, battery-containing, small, integrated neurostimulator was designed to specifically target both the ON and SON. A prospective, multicenter feasibility study was undertaken to assess the device and therapy in the treatment of chronic migraine. Clinical outcomes and feedback on surgical techniques were collected.

Results: Subjects (n=11) underwent bilateral placement of leads targeting ON and SON. An initial incision allowed for a pocket creation at the level of the nuchal ridge and partial implantable pulse generator (IPG) insertion. Leads were then inserted in the subcutaneous space and tunneled to the SON first, followed by the ON without the need for tunneling or lead extensions. Subjects could use the device all day if needed without an external power source. This approach was taken on both sides of the head, in two stages (right and left) resulting in efficient bilaterial coverage. Multiple indices of migraine improvement were reported. Adverse events spontaneously resolved with the most common being post-procedural soreness. No lead migrations or fractures have been reported.

Conclusion : Previous systems have utilized leads targeting head nerves that were then tunneled subcutaneously within the neck to an IPG typically located in the subscapular, subclavicular or buttock region. Having leads traverse the neck and, potentially, involving long connections across the torso can increase implantation time and risks of migration and fracture. Having a system completely regionalized to the head helps eliminate mechanical elements that contribute to device performance issues previously described.