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SPG Pulsed Radiofrequency for Chronic Cluster Headache

RecruitingNAAges 18 Years - anyAllBeijing Tiantan Hospital
NCT06787677 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • PRF
  • NB
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Where

1 site
Fang Luo
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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