Pulsed radiofrequency treatment for chronic cluster headache
The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache
This study is testing a new treatment using pulsed radiofrequency for people with chronic cluster headaches who haven't found relief from regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06787677 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of pulsed radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) as a treatment for chronic cluster headache (CH). Patients with chronic CH who have not responded to standard medications will be enrolled in a randomized, controlled trial to assess the effectiveness of this minimally invasive procedure. The study aims to address the significant unmet need for effective therapies for this debilitating condition, which affects a small percentage of the population. Participants will undergo PRF treatment and will be monitored for outcomes related to headache frequency and severity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic cluster headaches experiencing at least four attacks per week and who have not responded to standard treatments.
Not a fit: Patients who are pregnant, have certain cardiac devices, or have a history of serious psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from chronic cluster headaches.
How similar studies have performed: Previous studies have indicated that pulsed radiofrequency treatment for similar conditions has shown promise, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Fang Luo — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Fang Luo
- Email: 13611326978@163.com
- Phone: 59976661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.