TY - JOUR
T1 - Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study: Rationale and protocol of a randomised trial
AU - Wilbrink, Leopoldine A.
AU - Teernstra, Onno P. M.
AU - Haan, Joost
AU - van Zwet, Erik W.
AU - Evers, Silvia M. A. A.
AU - Spincemaille, Geert H.
AU - Veltink, Peter H.
AU - Mulleners, Wim
AU - Brand, Ronald
AU - Huygen, Frank J. P. M.
AU - Jensen, Rigmor H.
AU - Paemeleire, Koen
AU - Goadsby, Peter J.
AU - Visser-Vandewalle, Veerle
AU - Ferrari, Michel D.
PY - 2013/11
Y1 - 2013/11
N2 - 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.
AB - 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.
KW - Cluster headache
KW - occipital nerve stimulation
KW - ICON study
KW - chronic cluster headache
KW - study protocol
KW - Trial registration: Clinical trials
KW - gov NCT01151631
U2 - 10.1177/0333102413490351
DO - 10.1177/0333102413490351
M3 - Article
C2 - 23720502
SN - 0333-1024
VL - 33
SP - 1238
EP - 1247
JO - Cephalalgia
JF - Cephalalgia
IS - 15
ER -