SPG Pulsed Radiofrequency for Chronic Cluster Headache
ConditionHeadache, Cluster
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
Pregnancy or breastfeeding;
Presence of cardiac pacemaker or other neuromodulatory devices;
Pyschiatric and cognitive disorders;
Serious drug habituation or overuse of acute-headache medication;
Trial design
Treatments tested in this trial
- PRF
- NB
Treatment groups
108 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov