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-controlled trial

Ferrari, Michel; Wilbrink, Leopoldine A.; Coo, Ilse F. de; Doesborg, Patty G. G.; Bartels, Eveline C.; Zwet, Erik W. van; Huygen, Frank; Mulleners, Wim M.; Dongen, R.T.M. van; Kurt, Erkan; Teernstra, Onno P.M.; Koehler, Peter J.; Spincemaille, G.H.; Wille, Frank; Bürger, Katja; Haan, Joost; Couturier, E. G. M.; Kallewaard, Jan Willem; Veltink, Petrus H.; Schoenen, Jean; Magis, Delphine; Erőss, Lóránd; Áfra, Judit; Göbel, Hartmut; Heinze, Axel; Tronnier, V.; Rasche, Dirk

doi:10.1016/s1474-4422(21)00101-0

Cited by 43 publications

(63 citation statements)

References 44 publications

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“…169 Although previous invasive procedures include destructive lesions such as trigeminal nerve sectioning, 170 these have largely been replaced by implantable neuromodulation devices. Occipital nerve stimulation was found to be effective in several open label studies of 44-105 patients, [171][172][173][174] and more recently in a randomized dose controlled trial of 131 participants with medically refractory chronic cluster headache (defined as non-response to, intolerance of, or a contraindication to verapamil, lithium, and one other preventive drug). 174 Greater occipital nerve blocks were not predictive of response to occipital nerve stimulation, 175 but occipital nerve stimulation likely has a similar mechanism of action via modulation of the trigeminocervical complex.…”

Section: Special Populationsmentioning

confidence: 99%

“…Occipital nerve stimulation was found to be effective in several open label studies of 44-105 patients, [171][172][173][174] and more recently in a randomized dose controlled trial of 131 participants with medically refractory chronic cluster headache (defined as non-response to, intolerance of, or a contraindication to verapamil, lithium, and one other preventive drug). 174 Greater occipital nerve blocks were not predictive of response to occipital nerve stimulation, 175 but occipital nerve stimulation likely has a similar mechanism of action via modulation of the trigeminocervical complex. Complications of occipital nerve stimulation included infection, stimulator lead problems such as migration and fracture, and pain at the lead or generator sites.…”

Section: Special Populationsmentioning

confidence: 99%

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Recent advances in the diagnosis and management of cluster headache

Schindler

Burish

2022

BMJ

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Cluster headache, a primary headache disorder, consists of short (15-180 minutes), frequent (up to eight a day), unilateral attacks of facial pain with associated ipsilateral autonomic features and restlessness. The attacks are suspected to be one of the most painful human experiences, and the disorder is associated with a high rate of suicidal ideation. Proper diagnosis is key, as some of the most effective treatments, such as high flow oxygen gas, are rarely used in other headache disorders. Yet diagnostic delay is typically years for this disorder, as it is often confused with migraine and trigeminal neuralgia, and secondary causes may be overlooked. This review covers the clinical, pathophysiologic, and therapeutic features of cluster headache. Recent updates in diagnosis include the redefinition of chronic cluster headache (remission periods lasting less than three months instead of the previous one month), and recent advances in management include new treatments for episodic cluster headache (galcanezumab and non-invasive vagus nerve stimulation).

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Section: Special Populationsmentioning

confidence: 99%

Section: Special Populationsmentioning

confidence: 99%

Recent advances in the diagnosis and management of cluster headache

Schindler

Burish

2022

BMJ

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“…In a unique international, multicentre, randomised, double-blind, phase 3, electrical dose-controlled clinical trial, 131 patients with drug-resistant CCH underwent 24 weeks of ONS at either 100% ( N = 65, verum) or 30% ( N = 66, sham) of the individually determined range between paraesthesia threshold and near discomfort [ 122 ••]. At the end of the randomisation phase, both groups achieved a 50% response rate in 44.6% of the cases.…”

Section: Invasive Neuromodulatory Techniquesmentioning

confidence: 99%

Neuromodulation for Chronic Daily Headache

Magis

Casillo

Sebastianelli

et al. 2022

Curr Pain Headache Rep

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Purpose of Review We reviewed the literature that explored the use of central and peripheral neuromodulation techniques for chronic daily headache (CDH) treatment. Recent Findings Although the more invasive deep brain stimulation (DBS) is effective in chronic cluster headache (CCH), it should be reserved for extremely difficult-to-treat patients. Percutaneous occipital nerve stimulation has shown similar efficacy to DBS and is less risky in both CCH and chronic migraine (CM). Non-invasive transcutaneous vagus nerve stimulation is a promising add-on treatment for CCH but not for CM. Transcutaneous external trigeminal nerve stimulation may be effective in treating CM; however, it has not yet been tested for cluster headache. Transcranial magnetic and electric stimulations have promising preventive effects against CM and CCH. Summary Although the precise mode of action of non-invasive neuromodulation techniques remains largely unknown and there is a paucity of controlled trials, they should be preferred to more invasive techniques for treating CDH.

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“…Serious adverse events, such as pain, were reported in 26% of the high-stimulation and 12% of the lowstimulation groups. 33 Non-invasive stimulation of the vagus nerve has been studied for acute treatment of cluster headache in two randomised, sham-controlled trials. There was a significant response in episodic cluster headache, but not chronic cluster headache.…”

Section: Neuromodulationmentioning

confidence: 99%

“…Serious adverse events, such as pain, were reported in 26% of the high-stimulation and 12% of the low-stimulation groups. 33 …”

Section: Neuromodulationmentioning

confidence: 99%

Cluster headache in adults

Ray¹,

Stark²,

Hutton³

2022

Aust Prescr

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Cluster headache is characterised by attacks of very severe, unilateral headache lasting 15-180 minutes, up to eight times per day. The attacks are associated with cranial autonomic symptoms on the same side and a sense of agitation or restlessness.First-line acute abortive treatments include intranasal or subcutaneous sumatriptan or high-flow oxygen. Neuromodulation may benefit some patients.First-line preventive therapy is high-dose verapamil. Close monitoring is required for the adverse effect of arrhythmia. PathophysiologyThe pathophysiology of cluster headache is not completely understood. With advances in clinical and neuroimaging studies, the vascular theory of cluster headache is now considered incomplete. 11 There are vascular changes, but they are a consequence

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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-controlled trial

Cited by 43 publications

References 44 publications

Recent advances in the diagnosis and management of cluster headache

Recent advances in the diagnosis and management of cluster headache

Neuromodulation for Chronic Daily Headache

Cluster headache in adults

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