SPG Pulsed Radiofrequency for Chronic Cluster Headache

NCT06787677 | Recruiting

• 1 other identifier: KY 2018-027-02-1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Headache, Cluster

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean attack frequency

  From baseline to each 4-week interval through 1 year after procedure

• 50% reduction of mean attack frequency

  From baseline to each 4-week interval through 1 year after procedure

• 30% reduction of mean attack frequency

  From baseline to each 4-week interval through 1 year after procedure

• Patient Global Impression of Improvement

  At month 1, month 2, month 3, month 6, and month 12 after procedure

• Mean attack intensity

  From baseline to each 4-week interval through 1 year after procedure

Study Arms (2)

PRF group

EXPERIMENTAL

Procedure: PRF

Nerve Block Group

ACTIVE COMPARATOR

Procedure: NB

Interventions

PRF PROCEDURE

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.

PRF group

NB PROCEDURE

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.

Nerve Block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Fang Luo

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 31701891 BACKGROUND

• 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.

  PMID: 36268950 RESULT

• 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.

  PMID: 34146510 RESULT

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Fang Luo

CONTACT

59976661; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: January 24, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)