Overview
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
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.