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

Cephalalgia

Volumn 33, Issue 15, 2013, Pages 1238-1247

  Wilbrink, Leopoldine A ^a,b   Teernstra, Onno P M ^b   Haan, Joost ^a,c   Van Zwet, Erik W ^a   Evers, Silvia M A A ^d   Spincemaille, Geert H ^a,b   Veltink, Peter H ^e   Mulleners, Wim ^f   Brand, Ronald ^a   Huygen, Frank J P M ^g   Jensen, Rigmor H ^h   Paemeleire, Koen ⁱ   Goadsby, Peter J ^j   Visser Vandewalle, Veerle ^k   Ferrari, Michel D ^a  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^c RIJNLAND HOSPITAL   (Netherlands)

^d MAASTRICHT UNIVERSITY   (Netherlands)

^e UNIVERSITY OF TWENTE   (Netherlands)

^f CANISIUS WILHELMINA HOSPITAL   (Netherlands)

^g ERASMUS MEDICAL CENTER   (Netherlands)

^h UNIVERSITY OF COPENHAGEN   (Denmark)

ⁱ GHENT UNIVERSITY HOSPITAL   (Belgium)

^j UNIVERSITY OF CALIFORNIA   (United States)

^k UNIVERSITY OF COLOGNE   (Germany)

more..

Author keywords

chronic cluster headache; Cluster headache; ICON study; occipital nerve stimulation; study protocol; Trial registration: Clinical trials.gov NCT01151631

Indexed keywords

ADULT; AMPLITUDE MODULATION; ARTICLE; CHRONIC CLUSTER HEADACHE; CLINICAL EFFECTIVENESS; CLINICAL PROTOCOL; COMPUTER PROGRAM; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; COST OF ILLNESS; COST UTILITY ANALYSIS; DOUBLE BLIND PROCEDURE; ECONOMIC EVALUATION; ELECTRODE IMPLANT; FEMALE; HEALTH CARE COST; HUMAN; IMPLANTABLE PULSE GENERATOR; INTRACTABLE PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NERVE STIMULATION; NEUROMODULATION; OCCIPITAL NERVE STIMULATION; OUTCOME ASSESSMENT; PARALLEL DESIGN; PROSPECTIVE STUDY; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL;

CHRONIC CLUSTER HEADACHE; CLUSTER HEADACHE; ICON STUDY; OCCIPITAL NERVE STIMULATION; STUDY PROTOCOL;

CLINICAL PROTOCOLS; CLUSTER HEADACHE; DOUBLE-BLIND METHOD; ELECTRIC STIMULATION THERAPY; ELECTRODES, IMPLANTED; HUMANS; RESEARCH DESIGN; SKULL;

EID: 84885716901     PISSN: 03331024     EISSN: 14682982     Source Type: Journal    
DOI: 10.1177/0333102413490351     Document Type: Article

References (37)

1. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004 ; 24: 9-160
2. Favier I, Haan J, Ferrari MD. Chronic cluster headache: A review. J Headache Pain. 2005 ; 6: 3-9
3. Russell MB. Epidemiology and genetics of cluster headache. Lancet Neurol. 2004 ; 3: 279-283
4. Jensen RM, Lyngberg A, Jensen RH. Burden of cluster headache. Cephalalgia. 2007 ; 27: 535-541
5. The Sumatriptan Cluster Headache Study Group. N Eng J Med. 1991 ; 325: 322-326
6. van Vliet JA, Bahra A, Martin V, et al. Intranasal sumatriptan in cluster headache. Randomised placebo-controlled double-blind study. Neurology. 2003 ; 60: 630-633
7. Cittadini E, May A, Straube A, et al. Effectiveness of intranasal zolmitriptan in acute cluster headache: A randomized, placebo-controlled, double-blind crossover study. Arch Neurol. 2006 ; 63: 1537-1542
8. Halker R, Vargas B, Dodick DW. Cluster headache: Diagnosis and treatment. Semin Neurol. 2010 ; 30: 175-185
9. Goadsby PJ, Schoenen J, Ferrari MD, et al. Towards a definition of intractable headache for use in clinical practice and trials. Cephalalgia. 2006 ; 26: 1168-1170
10. Matharu MS, Boes CJ, Goadsby PJ. Management of trigeminal autonomic cephalgias and hemicrania continua. Drugs. 2003 ; 63: 1637-1677
11. Gantenbein AR, Lutz NJ, Riederer F, et al. Efficacy and safety of 121 injections of the greater occipital nerve in episodic and chronic cluster headache. Cephalalgia. 2012 ; 32: 630-634
12. May A, Bahra A, Büchel C, et al. Hypothalamic activation in cluster headache attacks. Lancet. 1998 ; 352: 275-278
13. Leone M, Franzini A, Bussone G. Stereotactic stimulation of posterior hypothalamic grey matter in a patient with intractable cluster headache. N Engl J Med. 2001 ; 345: 1428-1429
14. Schoenen J, Di Clemente L, Vandenheede M, et al. Hypothalamic stimulation in chronic cluster headache: A pilot study of efficacy and mode of action. Brain. 2005 ; 128: 940-947
15. Fontaine D, Christophe SJ, Raoul S, et al. Treatment of refractory chronic cluster headache by chronic occipital nerve stimulation. Cephalalgia. 2011 ; 31: 1101-1105
16. Magis D, Gerardy PY, Remacle JM, et al. Sustained effectiveness of occipital nerve stimulation in drug-resistant chronic cluster headache. Headache. 2011 ; 51: 1191-1201
17. Burns B, Watkins L, Goadsby PJ. Treatment of medically intractable cluster headache by occipital nerve stimulation: Long-term follow-up of eight patients. Lancet. 2007 ; 369: 1099-1106
18. Burns B, Watkins L, Goadsby PJ. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology. 2009 ; 72: 341-345
19. Magis D, Allena M, Bolla M, et al. Occipital nerve stimulation for drug-resistant chronic cluster headache: A prospective pilot study. Lancet Neurol. 2007 ; 6: 314-321
20. Bartsch T, Goadsby PJ. Stimulation of the greater occipital nerve induces increased central excitability of dural afferent input. Brain. 2002 ; 125: 1496-1509
21. Goadsby PJ, Knight YE, Hoskin KL. Stimulation of the greater occipital nerve increases metabolic activity in the trigeminal nucleus caudalis and cervical dorsal horn of the cat. Pain. 1997 ; 73: 23-28
22. Kerr FW, Olfanson RA. Trigeminal and cervical volleys. Convergence on single units in the spinal gray at C-1 and C-2. Arch Neurol. 1961 ; 5: 171-178
23. Busch V, Jakob W, Juergens T, et al. Functional connectivity between trigeminal and occipital nerves revealed by occipital nerve blockade and nociceptive blink reflexes. Cephalalgia. 2006 ; 26: 50-55
24. Magis D, Bruno MA, Fumal A, et al. Central modulation in cluster headache patients treated with occipital nerve stimulation: An FDG-PET study. BMC Neurol. 2011 ; 11: 25-25
25. Ben Menachem E, Mañon-Espaillat R, Ristanovic R, et al. Vagus nerve stimulation for treatment of partial seizures: 1. A controlled study of effect on seizures. First International Vagus Nerve Stimulation Study Group. Epilepsia. 1994 ; 35: 616-626
26. Matharu MS, Bartsch T, Ward N, et al. Central neuromodulation in chronic migraine patients with suboccipital stimulators: A PET study. Brain. 2004 ; 127: 220-230
27. Trentman TL, Zimmerman RS. Occipital nerve stimulation: Technical and surgical aspects of implantation. Headache. 2008 ; 48: 319-327
28. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 ; 30: 473-483
29. Koopmanschap MA. PRODISQ: A modular questionnaire on productivity and disease for economic evaluation studies. Expert Rev Pharmacoecon Outcomes Res. 2005 ; 5: 23-28
30. Marcus R. On closed testing procedures with special reference to ordered analysis of variance. Biometrika. 1976 ; 63: 655-660
31. Barber JA, Thompson SG. Analysis of cost data in randomized trials: An application of the non-parametric bootstrap. Stat Med. 2000 ; 19: 3219-3236
32. Ramsey S, Willke R, Briggs A, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: The ISPOR RCT-CEA Task Force report. Value Health. 2005 ; 8: 521-533
33. Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: A non-parametric approach to confidence interval estimation. Health Econ. 1997 ; 6: 327-340
34. Hakkaart-van Roijen L Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P). Rotterdam: Institute for Medical Technology Assessment Erasmus Universiteit Rotterdam ; 2002 :
35. Farmacotherapeutisch Kompas (Pharmacotherapeutic Compass). Amstelveen: College voor zorgverzekeringen ; 2009 :
36. Silberstein SD, Dodick DW, Saper J, et al. Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: Results from a randomized, multicenter, double-blinded, controlled study. Cephalalgia. 2012 ; 32: 1165-1179
37. Saper JR, Dodick DW, Silberstein SD, et al. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia. 2011 ; 31: 271-285