Occipital nerve stimulation effective and safe in chronic cluster headache

Occipital nerve stimulation resulted in a rapid and persistent reduction of attack frequency in patients with medically intractable chronic cluster headache. In addition, the phase 3 ICON study demonstrated that this intervention was safe [1]. The results have recently been published in The Lancet Neurology [2].

In occipital nerve stimulation, electrodes are placed subcutaneously on the back of the head in the dermatomes of the occipital nerves. Multiple open-label studies have shown promising results in patients with medically intractable chronic cluster headache [3–5]. Dr Poldi Wilbrink (Zuyderland Medical Centre, the Netherlands) and colleagues investigated whether occipital nerve stimulation could serve as an effective treatment for this patient population.

The randomised, double-blind, multicentre, phase 3 ICON study (NCT01151631) evaluated occipital nerve stimulation in patients with medically intractable chronic cluster headache [1]. After a baseline period of 12 weeks, patients were randomly divided into a high-intensity (100%) or low-intensity (30%) stimulation group. In the subsequent 24 weeks, patients received individually optimised open-label occipital nerve stimulation. Of 150 patients enrolled, data from 131 patients was included in this study.

The mean weekly attack frequency in the total population was decreased from 7.58 at baseline to 5.96 in weeks 1–4, 5.57 in weeks 21–24, and 5.14 in weeks 45–48. No difference was found in attack frequency between the high- and low-intensity groups.

In the group receiving 100% occipital nerve stimulation, 129 adverse events (AEs) were registered versus 95 AEs in the group receiving 30% occipital nerve stimulation. “Most AEs were hardware-related,” Dr Wilbrink added. “For example, empty batteries or dislocation of the electrodes.”

A major point of discussion is that, despite an improvement in time, no difference in attack frequency between treatment arms receiving low or high stimulation was found. “This could be a placebo response,” Dr Wilbrink postulated. “However, we deem this unlikely, since this group of patients is severely affected, highly disabled, has long-term unremitting attacks, and no effect of multiple previous treatments.” No change during the baseline period of 12 weeks was found, which was followed by an abrupt, pronounced, and long-term sustained improvement for all outcomes. Future research should focus on optimising stimulation protocols and disentangling the underlying mechanism of action.

1. Wilbrink P, et al. 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. AL073, IHC 2021, 8-12 September.
2. Wilbrink LA, et al. Lancet Neurol. 2021;20(7):515–25.
3. Magis D, et al. Lancet Neurol. 2007;6(4):314–21.
4. Burns B, et al. Lancet. 2007;369(9567):1099–106.
5. Fontaine D, et al. Cephalalgia. 2011;31(10):1101–5.

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Posted on 8 November, 20218 February, 2024