Introduction

Chronic migraine (CM) is a major public health problem affecting approximately 2% of the adult population [1]. 10 kHz spinal cord stimulation (SCS) has proven to be effective in relieving chronic back and leg pain [2] and has also shown promising efficacy in a prospective study conducted in subjects with chronic migraine and medication overuse [3]. The aim of this study was to assess safety, tolerability and efficacy of 10 kHz SCS in refractory CM subjects. This is an off-label indication for SCS.

Methods/Materials

Twenty-five adults diagnosed with CM as per the International Headache Society’s diagnostic criteria and refractory to medical treatment (defined as a failure to respond to at least 3 prophylaxis therapies of which one is topiramate) were enrolled in this single-centre, open-label, prospective study. Medication overuse headache and severe depression were considered exclusion criteria. No stimulation trial was performed as a delayed response to neurostimulation was expected, and 20 subjects were implanted with a 10 kHz SCS system with the distal tip of leads positioned at the C2 vertebral level. Safety and effectiveness outcomes were captured up to 52 weeks.

Results

Summary of baseline data is presented in Table 1.

There was an average reduction of 3.6±2.1 and of 5.4±2.4 headache days/month at 12 weeks and 52 weeks respectively. Having 30% of subjects shown >30% reduction in headache days at 12 weeks and 50% at 52 weeks. Whereas the average reduction of migraine days was 6.7±2.4 and 9.3±2.5 at 12 and 52 weeks respectively. With 45% of subjects achieving a >30% reduction in migraine days at 12 weeks and 60% at 52 weeks. AT 52 weeks, 50% of the subjects had converted from a CM pattern to an episodic migraine patter. The average migraine-specific quality of life (MSQ) score improved 16.2 points at 24-weeks (49.6±23.2) and 24.8 points at 52-weeks (58.2±21.9). The average Migraine Disability Assessment Score (MIDAS) improved 47.1 points at 24-weeks (81.6±72.9) and 66 points at 52-weeks (62.7±63.8). At 52 weeks, 70% of the subjects were ‘much satisfied’ or ‘very much satisfied’ with the therapy and 55% reported ‘much improved’ or ‘very much improved’. Study-related adverse events included 5 subjects with implantable pulse generator site pain.

Discussion

Not applicable.

Conclusions

The analysis supports the previous prospective study results suggesting that 10 kHz SCS may offer a potentially safe and effective therapeutic option for medically refractory CM, showing similar efficacy results to occipital nerve stimulation [4] and presenting a potentially safer profile.

References

1 -Lipton R. Chronic migraine, classification, differential diagnosis, and epidemiology. Headache. Headache. 2011;Jul-Aug(51(2)):77-83.

2 -Kapural L, et al. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg PainThe SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015;123(4):851-860.

3 -Arcioni R, et al. Cervical 10 kHz spinal cord stimulation in the management of chronic, medically refractory migraine: A prospective, open‐label, exploratory study. Eur J Pain. 2016 70-78.

4 -Silberstein S, et al. The safety and efficacy of occipital nerve stimulation for the management of chronic migraine. Cephalalgia. 2011 117.