Peripheral nerve stimulation registry for intractable migraine headache (RELIEF): a real-life perspective on the utility of occipital nerve stimulation for chronic migraine

DOI: https://doi.org/10.1007/s00701-020-04372-z

Abstract-Summary To assess the safety and efficacy of neuromodulation in the treatment of intractable chronic migraine using the Abbott occipital nerve stimulator.

Patients over the age of 18 who had failed three or more preventative drugs, had at least moderate disability based on MIDAS or HIT-6 score and were implanted with an Abbott neurostimulator were included in the study. Patients were followed up for a maximum of 24 months. Data were collected on adverse events, headache relief, headache days, quality of

life, migraine disability, satisfaction and quality of life.

One hundred twelve patients were included, 79 female and 33 male, with 45

patients reaching the maximum follow-up of 24 months.

At 3 months, 33.7% were satisfied or very satisfied with the procedure with

43.0% reporting improved or greatly improved quality of life.

67.5% indicated that they would undergo the procedure again with satisfaction peaking at 9 months when 49.3% were satisfied or very satisfied with the procedure. At 24 months, 46.7% of available patients were satisfied or very satisfied with

the procedure—18% of enrolled patients.

Neuromodulation can be beneficial for selected patients with intractable chronic migraine although frequent complications have been consistently reported across studies.

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Background Approximately, 1.3–2.4% of these cases will progress to chronic migraine [492– 494] which is typified by migraines for ≥15 days per month, for more than 3 months with a minimum of 8 days per month characterised with migraine headache [495, 496].

Despite significant advances in the pharmacological management of patients with chronic migraine [497], the latter remains intractable to medical treatment in many cases [498].

This leads to medication overuse, which affects 1–2% of the general population

and is reported for up to 78% of patients with chronic migraine [499, 500].

A number of randomised trials assessing the effectiveness of occipital nerve stim- ulation for the treatment of migraine have reported some clinical benefit with the technique in the short term, but with increased rates of adverse events [501–503], and results that might have been amplified by the lack of effective blinding [504].

We report our outcomes from a multi-national, multi-centre, prospective study in patients implanted with an Abbott (formerly known as St Jude Medical) implantable neurostimulation system for the treatment of intractable chronic migraine.

Objective These were adverse events, headache pain relief, headache days, migraine disabil- ity, satisfaction and quality of life.

Data were collected by direct questioning of the patients at each visit as well as the Migraine Disability Assessment (MIDAS) [505, 506] and Headache Impact Test (HIT-6) [505] questionnaires.

Data regarding both patient and clinician satisfaction with the therapy were

obtained at 3, 6, 9, 12, 18 and 24 months.

Methods All patients implanted with Abbott implantable neurostimulation system for intrac- table chronic migraine were eligible for enrolment to a prospective, observational and non-interventional study, the Relief registry.

We included patients that Were 18 years of age or older Had been implanted with an Abbott CE approved implantable neurostimulation system for the treatment of intractable chronic migraine Had failed three or more preventative drugs Had at least moderate disability determined by the use of a validated migraine disability instrument (e.g. MIDAS > 11 or HIT-6 > 56) Had signed and received a copy of the informed consent.

Satisfaction and quality of life data were reported by asking both patients and clinicians at each visit to rate their satisfaction with headache relief since permanent implantation was choosing one of the following: very satisfied, satisfied, neither satisfied nor dissatisfied, unsatisfied and very unsatisfied.

Results At 3 months, patients with no adverse events reported a decrease of 20.4 days (43%); patients who experienced an AE not requiring additional surgery reported a decrease of 16.1 (38%) days while patients who experienced an AE that did require additional surgery reported a decrease of 12.4 days (35%).

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At the 3-month visit, 29.4% of patients with no adverse events reported they were satisfied or very satisfied with the therapy, while 37.9% of patients who expe- rienced an AE not requiring additional surgery and 32.4% patients who experienced an AE that did require additional surgery reported they were satisfied or very satis- fied with the therapy.

At the 3-month visit, patients with no adverse events reported a 41% score reduc- tion in MIDAS score, while patients who experienced an AE not requiring addi- tional surgery reported a decrease of 49%; with those who experienced an AE that did require additional surgery reporting a decrease of 22%.

Discussion In terms of design, the parallel group trials included an initial 12-week blinded phase where patients received either active or sham stimulation [501, 503].

The study of Serra and Marchioretto divided patients into 2 groups, with one group having the stimulator switched “on” and the other group “off” for one month. In terms of MIDAS scores at 3 months, Saper reported a mean change in average scores of 0.4 ± 0.8 for those receiving ONS; Silberstein reported on the difference in mean reduction in the scores between patients receiving ONS and those receiving sham stimulation of 44.1  in favour of the treatment group; and lastly, Serra and Marchioretto reported the median total score for both groups combined showing a reduction from 79 at baseline to 19 at 3 months.

Conclusion ONS can be beneficial for a proportion of patients with refractory chronic migraine with a consistent risk profile across multiple studies.

Randomised trials with long-term follow up designs are needed to clearly define

the role of ONS in the management of patients with chronic migraine.

Acknowledgement A machine generated summary based on the work of Ashkan, Keyoumars; Sokratous, Giannis; Göbel, Hartmut; Mehta, Vivek; Gendolla, Astrid; Dowson, Andrew; Wodehouse, Theresa; Heinze, Axel; Gaul, Charly. 2020 in Acta Neurochirurgica.

Clinical experience with transcutaneous supraorbital nerve stimulation in patients with refractory migraine or with migraine and intolerance to topiramate: a prospective exploratory clinical study