Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06787677

Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment 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 is a severe condition causing intense, one-sided headaches with related nerve symptoms, affecting about 0.1% of people yearly. There is a strong need for effective treatments. This research evaluates the safety and effectiveness of pulse radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) in patients with chronic cluster headache through a randomized, controlled trial. Participants receive one of two treatments after a needle is placed at the SPG. One group undergoes PRF treatment automatically for 360 seconds at a temperature up to 42°C, with specific pulse frequency and width settings. The other group receives a nerve block injection containing triamcinolone, bupivacaine, saline, and epinephrine. These procedures are designed to compare the effects of PRF versus nerve block for chronic cluster headache. Throughout the study, researchers monitor how often headache attacks occur during the last four weeks after treatment (weeks 8 to 12). Participants are assessed for treatment safety and response, with data collected on attack frequency. The study includes adults aged 18 and older with chronic cluster headache, tracking outcomes to establish how well the treatments work and their safety profiles.

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

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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

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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Published Research Related To This Trial

Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial.

Peter J Goadsby, Soma Sahai-Srivastava, Eric J Kezirian...

https://pubmed.ncbi.nlm.nih.gov/31701891

Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache (ICON): a randomised, double-blind, multicentre, phase 3, electrical dose-controlled trial.

Leopoldine A Wilbrink, Ilse F de Coo, Patty G G Doesborg...

https://pubmed.ncbi.nlm.nih.gov/34146510