Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06787677

SPG Pulsed Radiofrequency for Chronic Cluster Headache

Led by Beijing Tiantan Hospital · Updated on 2025-01-27

108

Participants Needed

1

Research Sites

309 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

SPG Pulsed Radiofrequency for Chronic Cluster Headache

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 contraindication to topiramate, or gabapentin
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Presence of cardiac pacemaker or other neuromodulatory devices
  • Psychiatric 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fang Luo

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

F

Fang Luo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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