SPG Pulsed Radiofrequency for Chronic Cluster Headache

Last updated: January 23, 2025
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain (Pediatric)

Trigeminal Neuralgia

Treatment

NB

PRF

Clinical Study ID

NCT06787677
KY 2018-027-02-1
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

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, orcontraindication to verapamil and lithium, along with non-response, intolerance, orcontraindica-tion to topiramate, or gabapentin.

Exclusion

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 acutecardiovascular events;

  • Infection at the puncture site;

  • Previous history of invasive treatments such as sphenopalatine ganglionradiofrequency thermocoagulation and chemical destruction.

Study Design

Total Participants: 108
Treatment Group(s): 2
Primary Treatment: NB
Phase:
Study Start date:
January 24, 2025
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Fang Luo

    Beijing, Beijing 100070
    China

    Active - Recruiting

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