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

Leopoldine A Wilbrink; Onno Pm Teernstra; Joost Haan; Erik W van Zwet; Silvia Maa Evers; Geert H Spincemaille; Peter H Veltink; Wim Mulleners; Ronald Brand; Frank Jpm Huygen; Rigmor H Jensen; Koen Paemeleire; Peter J Goadsby; Veerle Visser-Vandewalle; Michel D Ferrari

doi:10.1177/0333102413490351

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

Leopoldine A Wilbrink, Onno Pm Teernstra, Joost Haan, Erik W van Zwet, Silvia Maa Evers, Geert H Spincemaille, Peter H Veltink, Wim Mulleners, Ronald Brand, Frank Jpm Huygen, Rigmor H Jensen, Koen Paemeleire, Peter J Goadsby, Veerle Visser-Vandewalle, Michel D Ferrari

47 Citations (Scopus)

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.

Original language	English
Journal	Cephalalgia
ISSN	0333-1024
DOIs	https://doi.org/10.1177/0333102413490351
Publication status	Published - Nov 2013

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Wilbrink, L. A., Teernstra, O. P., Haan, J., van Zwet, E. W., Evers, S. M., Spincemaille, G. H., Veltink, P. H., Mulleners, W., Brand, R., Huygen, F. J., Jensen, R. H., Paemeleire, K., Goadsby, P. J., Visser-Vandewalle, V., & Ferrari, M. D. (2013). Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study: Rationale and protocol of a randomised trial. Cephalalgia. https://doi.org/10.1177/0333102413490351

Wilbrink, LA, Teernstra, OP, Haan, J, van Zwet, EW, Evers, SM, Spincemaille, GH, Veltink, PH, Mulleners, W, Brand, R, Huygen, FJ, Jensen, RH, Paemeleire, K, Goadsby, PJ, Visser-Vandewalle, V & Ferrari, MD 2013, 'Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study: Rationale and protocol of a randomised trial', Cephalalgia. https://doi.org/10.1177/0333102413490351

@article{5944fa4549aa49bc92abdf7e6cf05f43,

title = "Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study: Rationale and protocol of a randomised trial",

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.",

author = "Wilbrink, {Leopoldine A} and Teernstra, {Onno Pm} and Joost Haan and {van Zwet}, {Erik W} and Evers, {Silvia Maa} and Spincemaille, {Geert H} and Veltink, {Peter H} and Wim Mulleners and Ronald Brand and Huygen, {Frank Jpm} and Jensen, {Rigmor H} and Koen Paemeleire and Goadsby, {Peter J} and Veerle Visser-Vandewalle and Ferrari, {Michel D}",

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doi = "10.1177/0333102413490351",

language = "English",

journal = "Cephalalgia, Supplement",

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T1 - Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study

T2 - Rationale and protocol of a randomised trial

AU - Wilbrink, Leopoldine A

AU - Teernstra, Onno Pm

AU - Haan, Joost

AU - van Zwet, Erik W

AU - Evers, Silvia Maa

AU - Spincemaille, Geert H

AU - Veltink, Peter H

AU - Mulleners, Wim

AU - Brand, Ronald

AU - Huygen, Frank Jpm

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.

U2 - 10.1177/0333102413490351

DO - 10.1177/0333102413490351

M3 - Journal article

C2 - 23720502

SN - 0800-1952

JO - Cephalalgia, Supplement

JF - Cephalalgia, Supplement

ER -

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

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