Decreasing the Risk of Lead Migration in Occipital Nerve Stimulation for Cluster Headache Using Dedicated Leads

OBJECTIVE: Our aim was to assess the effectiveness and complication rate of occipital nerve stimulation (ONS) using a recently developed anchoring lead dedicated to ONS in patients treated for refractory chronic cluster headache (rCCH). MATERIALS AND METHODS: Patients with rCCH were included in a prospective multicenter ONS registry from 2019 to 2024 and treated by ONS using anchored ONS-dedicated leads. The effectiveness of ONS was evaluated by the frequency of chronic cluster headache (CCH) attacks, abortive and preventive medication use, quality of life (EuroQol-5 Dimensions scale), and the functional (Headache Impact Test-6) and emotional (Hospital Anxiety and Depression Scale) impacts. Complications were monitored, focusing on electrode migration, device malfunction, infections, and local pain. RESULTS: Overall, 40 (16 women, mean age 46 years) and 24 patients were followed for one and two years after ONS, respectively. The mean weekly attack frequency significantly decreased, from 24.3 before ONS to 12.7 (p = 0.006) at one year and to 11.7 (p = 0.002) at two years. Functional and emotional impacts and quality of life significantly improved. During the follow-up period, 16 patients experienced device-related complications, including infection (7.5%), lead migration (5%), hardware dysfunction (15%), and pain at the lead insertion site (12.5%). CONCLUSION: ONS using ONS-dedicated leads showed similar effectiveness, while also presenting a low risk of migration, to ONS using other leads reported in previous studies. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT01842763.