SPG Pulsed Radiofrequency for Chronic Cluster Headache

The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache

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.

Study Overview

• Status: Recruiting
• Conditions: Headache, Cluster
• Intervention / Treatment: Procedure: PRF; Procedure: NB

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Luo; Phone Number: 59976661; Email: 13611326978@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Fang Luo
      • Contact: Fang Luo; Phone Number: 59976661; Email: 13611326978@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF group	Procedure: PRF; After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the PRF group received PRF treatment in automatic mode for 360 s, at a maximum of 42°C, pulse frequency of 2 Hz, and pulse width of 20 ms.
Active Comparator: Nerve Block Group	Procedure: NB; After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the NB group received nerve block with a mixture of 40 mg of triamcinolone and 2 ml of 0.75% bupivacaine with 2 ml of normal saline and 1:100000 epinephrine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean attack frequency in the last 4 weeks (week 8-12) after procedure	The overall mean change from baseline in mean weekly attack frequency	In the last 4 weeks (week 8-12) after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean attack frequency	Mean change in mean attack frequency	From baseline to each 4-week interval through 1 year after procedure
50% reduction of mean attack frequency	Percentage of patients with a 50% reduction in mean attack frequency	From baseline to each 4-week interval through 1 year after procedure
30% reduction of mean attack frequency	Percentage of patients with a 30% reduction in mean attack frequency	From baseline to each 4-week interval through 1 year after procedure
Patient Global Impression of Improvement	Percentage of patients reporting a score of 1 (''very much better'') or 2 (''much better'')	At month 1, month 2, month 3, month 6, and month 12 after procedure
Mean attack intensity	0-10 on the numeric rating scale, with 0 equating no pain and 10 the worst pain possible	From baseline to each 4-week interval through 1 year after procedure
Patient satisfaction scores	0 point indicates unsatisfied to 10 points indicate very satisfied. The higher the score, the more dissatisfied the patient is.	At month 1, month 2, month 3, month 6, and month 12 after procedure
The incidence of perioperative adverse events	Perioperative adverse events (AEs) including headache, dizziness, nausea, vomiting, facial hematoma, and numbness in the area innervated by the maxillary nerve	Across 1 year after procedure

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Publications and helpful links

General Publications

• Goadsby PJ, Sahai-Srivastava S, Kezirian EJ, Calhoun AH, Matthews DC, McAllister PJ, Costantino PD, Friedman DI, Zuniga JR, Mechtler LL, Popat SR, Rezai AR, Dodick DW. Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial. Lancet Neurol. 2019 Dec;18(12):1081-1090. doi: 10.1016/S1474-4422(19)30322-9.
• Schoenen J, Snoer AH, Brandt RB, Fronczek R, Wei DY, Chung CS, Diener HC, Dodick DW, Fontaine D, Goadsby PJ, Matharu MS, May A, McGinley JS, Tepper SJ, Jensen RH, Ferrari MD; IHS Standing Committee for Clinical Trials; IHS cluster headache trial guideline subcommittee. Guidelines of the International Headache Society for Controlled Clinical Trials in Cluster Headache. Cephalalgia. 2022 Dec;42(14):1450-1466. doi: 10.1177/03331024221120266. Epub 2022 Oct 21.
• Wilbrink LA, de Coo IF, Doesborg PGG, Mulleners WM, Teernstra OPM, Bartels EC, Burger K, Wille F, van Dongen RTM, Kurt E, Spincemaille GH, Haan J, van Zwet EW, Huygen FJPM, Ferrari MD; ICON study group. 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. Lancet Neurol. 2021 Jul;20(7):515-525. doi: 10.1016/S1474-4422(21)00101-0.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache
• Other Study ID Numbers: KY 2018-027-02-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No