SPG Pulsed Radiofrequency for Chronic Cluster Headache
Trial Parameters
Brief Summary
Cluster headache (CH) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. There is a huge clinically unmet demand for an effective therapeutic method for CH. Previous evidences indicate that pulse radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) is a safe, minimally invasive, effective treatment for CH. This randomized, controlled trial aimed to establish the safety and efficacy of SPG PRF for patients with chronic CH.
Eligibility Criteria
Inclusion Criteria: * Chronic cluster headache; * At least four attacks per week; * Minimum age of 18 years; * Non-response to verapamil and lithium treatment in the past, intolerance, or contraindication to verapamil and lithium, along with non-response, intolerance, or contraindica-tion to topiramate, or gabapentin. Exclusion Criteria: * Pregnancy or breastfeeding; * Presence of cardiac pacemaker or other neuromodulatory devices; * Pyschiatric and cognitive disorders; * Serious drug habituation or overuse of acute-headache medication; * History of stroke or intracranial aneurysm, or at risk for serious or acute cardiovascular events; * Infection at the puncture site; * Previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction.