Recruiting NCT06787677
SPG Pulsed Radiofrequency for Chronic Cluster Headache
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRF, NB.
- Who it may be relevant to
- Registry conditions: Headache, Cluster. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- The mean attack frequency in the last 4 weeks (week 8-12) after procedure [Time frame: In the last 4 weeks (week 8-12) after procedure]
Secondary outcome measures (7)
- Mean attack frequency [Time frame: From baseline to each 4-week interval through 1 year after procedure]
- 50% reduction of mean attack frequency [Time frame: From baseline to each 4-week interval through 1 year after procedure]
- 30% reduction of mean attack frequency [Time frame: From baseline to each 4-week interval through 1 year after procedure]
- Patient Global Impression of Improvement [Time frame: At month 1, month 2, month 3, month 6, and month 12 after procedure]
- Mean attack intensity [Time frame: From baseline to each 4-week interval through 1 year after procedure]
- Patient satisfaction scores [Time frame: At month 1, month 2, month 3, month 6, and month 12 after procedure]
- The incidence of perioperative adverse events [Time frame: Across 1 year after procedure]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fang Luo — Beijing
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. PMID 31701891
- 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): PMID 36268950
- 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- PMID 34146510
Identifiers
NCT: NCT06787677 · KY 2018-027-02-1