Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study: Rationale and protocol of a randomised trial. (November 2013)

• Record Type: Journal Article
• Authors: Wilbrink, Leopoldine A; Teernstra, Onno PM; Haan, Joost; van Zwet, Erik W; Evers, Silvia MAA; Spincemaille, Geert H; Veltink, Peter H; Mulleners, Wim; Brand, Ronald; Huygen, Frank JPM; Jensen, Rigmor H; Paemeleire, Koen; Goadsby, Peter J; Visser-Vandewalle, Veerle; Ferrari, Michel D
• Is Part Of: Cephalalgia. Volume 33:Number 15(2013)
• Page Start: 1238
• Page End: 1247
• Publication Date: 2013-11
• Subjects: Cluster headache -- occipital nerve stimulation -- ICON study -- chronic cluster headache -- study protocol; Trial registration: Clinical trials.gov NCT01151631; Headache -- Periodicals; 616.8491
• DOI: 10.1177/0333102413490351
• Languages: English
• ISSNs: 0333-1024

Abstract

Background: About 10% of cluster headache patients have the chronic form. At least 10% of this chronic group is intractable to or cannot tolerate medical treatment. Open pilot studies suggest that occipital nerve stimulation (ONS) might offer effective prevention in these patients. Controlled neuromodulation studies in treatments inducing paraesthesias have a general problem in blinding. We have introduced a new design in pain neuromodulation by which we think we can overcome this problem. Methods/design: We propose a prospective, randomised, double-blind, parallel-group international clinical study in medically intractable, chronic cluster headache patients of high- versus low-amplitude ONS. Primary outcome measure is the mean number of attacks over the last four weeks. After a study period of six months there is an open extension phase of six months. Alongside the randomised trial an economic evaluation study is performed. Discussion: The ICON study will show if ONS is an effective preventive therapy for patients suffering medically intractable chronic cluster headache and if there is a difference between high- and low-amplitude stimulation. The innovative design of the study will, for the first time, assess efficacy of ONS in a blinded way.