Clinical trial NCT06787677: SPG Pulsed Radiofrequency for Chronic Cluster Headache
Official title: The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Headache, Cluster
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The mean attack frequency in the last 4 weeks (week 8-12) after procedure
timeFrame: In the last 4 weeks (week 8-12) after procedure
Secondary outcomes:
measure: Mean attack frequency
timeFrame: From baseline to each 4-week interval through 1 year after procedure
measure: 50% reduction of mean attack frequency
timeFrame: From baseline to each 4-week interval through 1 year after procedure
measure: 30% reduction of mean attack frequency
timeFrame: From baseline to each 4-week interval through 1 year after procedure
measure: Patient Global Impression of Improvement
timeFrame: At month 1, month 2, month 3, month 6, and month 12 after procedure
measure: Mean attack intensity
timeFrame: From baseline to each 4-week interval through 1 year after procedure
measure: Patient satisfaction scores
timeFrame: At month 1, month 2, month 3, month 6, and month 12 after procedure
measure: The incidence of perioperative adverse events
timeFrame: Across 1 year after procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fang Luo
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.