Pulsed radiofrequency treatment for chronic cluster headache

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fang Luo
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Fang Luo
• Email: 13611326978@163.com
• Phone: 59976661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.