SPG Pulsed Radiofrequency for Chronic Cluster Headache

Capital Medical University

Status

Enrolling

Conditions

Headache, Cluster

Treatments

Procedure: PRF

Procedure: NB

Study type

Interventional

Funder types

Other

Identifiers

NCT06787677

KY 2018-027-02-1

Details and patient eligibility

About

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.

Enrollment

108 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.