gms | German Medical Science

Objective: Migraine is a highly prevalent disease and often refractory to medical therapy. ONS has been shown to provide pain relief in patients with refractory primary headache disorders. It is also less invasive than other surgical approaches; however, drawbacks have been reported, including technical issues with implantable components and lack of efficacy of the treatment. The mobility of the head-neck region causes patient discomfort at the implantation sites, when conventional straight wire SCS leads are used in ONS. We therefore investigated a new flexible, body compliant SCS lead and system for its suitability in ONS in a series of patients for efficacy, complications and overall outcome.

Methods: We hereby present a series of 10 patients suffering from chronic migraine (CM) (ICH criteria), who underwent ONS lead implantation (12 contact leads bilaterally, Algovita, Algostim). Prior to implantation, all patients received unsuccessfully conservative and surgical therapies, including antidepressants, occipital nerve blocks, opioids and botulinum toxin injections. Using a midline incision at C1-2, two 12 contact leads were placed subcutaneously and positioned under fluoroscopy bilaterally at the level of C1, respectively. Leads were tunneled and the generator was placed in an all-in-one procedure under general anesthesia.

Results: At three months follow-up, a reduction in headache days in 9 out of 10 patients (25.73 to 13.17 days) was observed, corresponding to a pain relief (9.9/7.1 on the VAS). Eight (8) patients reported a pain reduction of more than 30%, one (1) patient did not benefit so far (3 months postop). Decrease in pain led to an improvement in functional capacity of the patient during the 3 months follow-up post implantation. (6-months results will be included at the time of presentation). One failure occurred due to skin erosion of the lead tip during initial placement; a successful revision was performed. No other complications, side effects or reports on patients discomfort were noted.

Conclusion: There is an ongoing debate about optimal implant technique, indications and outcome measurement of ONS. By using a new 20% stretchable implantable lead, mechanical complications can be reduced. Due to delayed effect of the treatment we used an all-in-one approach with an outcome follow-up of 3-6 months. This series of implants was dedicated to proof technical advantages of the body compliant leads and pulse generator. Further prospective investigations are currently conducted to support this approach.