Interventional procedure overview of transcutaneous electrical stimulation of the supraorbital nerve for treating and preventing migraine

Corinna B; Giada U; Louis-David B et al. (2021) The bottom-up approach: Non-invasive peripheral neurostimulation methods to treat migraine: A scoping review from the child neurologist's perspective. European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society; 32; 16-28.

Review summarises 15 recent RCT to provide an overview of non-invasive peripheral neurostimulation methods currently available for the treatment of migraine.

Vagal nerve stimulation (VNS), remote electrical neuromodulation (REN) and SNS are considered effective in treating acute migraine attacks, the latter being more pronounced in migraine without aura. For migraine prevention, occipital nerve stimulation (ONS) and SNS showed efficacy, whereas repetitive neuromuscular magnetic stimulation (rNMS) may represent a further effective option in episodic migraine. peripheral neurostimulation represents a promising option to complement the multimodal therapy concept for paediatric migraine. In particular, rNMS opens a new field for research and treatment fitting the requirements of 'non-invasiveness' for children. Given the reported efficacy, safety, and feasibility, the therapy decision should be made on an individual level.

Review

Gerardy P, Fabry D, Fumal A et al. (2009) A pilot study on supra-orbital surface electrotherapy in migraine. Cephalalgia: 29:13

Not available

Not available

Goldberg SW and Nahas SJ (2015) Supratrochlear and supraorbital nerve stimulation for chronic headache: a review. Current Pain and Headache Reports 19: 26

Review of literature on supraorbital and supratrochlear nerve stimulation for chronic headache.

Haane D YP and Koehler PJ (2014). Nociception specific supraorbital nerve stimulation may prevent cluster headache attacks: serendipity in a blink reflex study. Cephalagia 34 (ca11), 920-6.

Serendipity study

n=7

A cluster headache pathophysiology study using 2 hourly nociception specific, bilateral transcutaneous supraorbital stimulation to elicit blink reflexes with or without oxygen treatment.

The authors discovered by chance that this could have a prophylactic effect in chronic cluster headache.

Not studied for the purpose of treating cluster headache.

Holger J, Mahmoud A, Vahagn K et al. (2021) Long-term experience with occipital and supraorbital nerve stimulation for the various headache disorders-A retrospective institutional case series of 96 patients. World Neurosurgery;151; e472-e483.

Retrospective review

n=96 patients with migraine, cervicogenic headache, cluster headache, neuropathic pain of the scalp, tension-type headache, and new daily persistent headache who had ONS (61.5%), SONS (11.5%), or combined ONS plus SONS (27.1%)

67.7% (65/96) were treatment responders to a trial (>=30% amelioration in the average or maximum VAS score for pain and/or number of headache days) that had lasted 22.5 +/- 8.8 days. The reduction in their average VAS score for pain was to 37% +/- 24.4% of baseline compared with 99.1% +/- 24.1% of baseline for those without a response (P < 0.01). Of the 56 patients who had had implantation and had long-term follow-up data available for <=10 years, 32 (57.1%) reported a >=50% reduction in their average VAS score for pain. Four patients (6.5%) had requested hardware explantation. Stage 2 complications included 1 infection (1.6%) and 6 electrode dislocations (9.7%). After careful patient selection according to a positive response to a trial of ONS and/or SONS, clinically meaningful long-term benefit was achieved in 57.1% of our patients with various chronic headache conditions.

Various chronic headaches with different types of treatment. Outcomes not reported separately for supraorbital nerve stimulation.

Joseph L, Maryna B, Anna PA et al. (2021) Noninvasive neuromodulation in headache: An update. Neurology India; 69 (12 suppl1); 183-s193.

Review

RCT as well as open-label and real-world studies on central and peripheral cephalic and non-cephalic neuromodulation modalities in primary headaches were critically reviewed.

The current evidence suggests a role of single-pulse transcranial magnetic stimulation, supraorbital nerve stimulation, and remote non-cephalic electrical stimulation as migraine abortive treatments, with stronger evidence in episodic rather than in chronic migraine. Single-pulse transcranial magnetic stimulation and supraorbital nerve stimulation also hold promising evidence in episodic migraine prevention and initial positive evidence in chronic migraine prevention. Neuromodulation is a promising nonpharmacological treatment approach for primary headaches. More studies with appropriate blinding strategies and reduction of device cost may allow more widespread approval of these treatments and in turn increase clinician's experience in neuromodulation.

Review

Lauritsen CG, Silberstein SD. Rationale for electrical parameter determination in external trigeminal nerve stimulation (eTNS) for migraine: A narrative review. Cephalalgia. May 2019;39(6):750-760. doi:10.1177/0333102418796781

Review

There is evidence of dysregulated central and peripheral pathways in migraine and evidence that eTNS may normalise function of these pathways. The electrical parameters were optimised specifically for external stimulation of the trigeminal nerve to maximum safety, comfort and efficacy.

Review

Magis D, D'Ostilio K, Thibaut A et al. (2017) Cerebral metabolism before and after external trigeminal nerve stimulation in episodic migraine, Cephalalgia. 37 (9), 881–891.

Case series (uncontrolled study)

N=34 patients

14 with episodic migraine treated with eTNS Cefaly

and compared with 20 healthy volunteers.

Follow up 3 months

The frequency of migraine attacks significantly decreased in compliant patients (n=10). Baseline FDG-PET scan revealed a significant hypometabolism in frontotemporal areas, especially in the orbitofrontal (OFC) and rostral anterior cingulate cortices (rACC) in patients with episodic migraine. This hypometabolism was reduced after three months of eTNS treatment. Metabolic activity of OFC and rACC, which are pivotal areas in central pain and behaviour control, is decreased in migraine.

Mechanism of action study (Brain metabolic changes before and after eTNS).

Riederer F, Penning S et al (2015). Transcutaneous Supraorbital Nerve Stimulation (t-SNS) with the Cefaly Device for Migraine Prevention: A Review of the Available Data.

Pain and Therapy 4 (2) 135-147.

Review of t-SNS with CEFALY

In a randomised, sham-controlled trial on 67 patients with episodic migraine the 50% responder rate after 3 months was significantly higher in the active group (38.2%) than in the sham group (12.1%); attack frequency, total headache days, acute antimigraine drug intake were also significantly reduced, but not headache severity. t-SNS was more effective in patients with a higher attack frequency. In a survey on 2313 Cefaly users only 4.3% of subjects reported side effects, all were minor and reversible, the most frequent being intolerance to the paraesthesia feeling and allergic skin reaction to the electrode gel. The efficacy of t-SNS with low-frequency migraine (<5 attacks/month) was recently confirmed in an open randomised trial. No published data are available in chronic migraine.

Review

Russo A, Tessitore A et al. (2015). Transcutaneous supraorbital neurostimulation in "de novo" patients with migraine without aura: the first Italian experience. The Journal of Headache and Pain 16:69, 1–7

Case series

n=24 patients with migraine without aura

tSNS (with a Cefaly device) was delivered with a high frequency (60Hz, 250 µs and 16 mA intensity)

Follow up: 60 days

A statistically significant decrease in the frequency of migraine attacks (p<0.001) and migraine days (p<0.001) per month; at least 50% reduction of monthly migraine attacks and migraine days in respectively 81 and 75% of patients were noted. A statistically significant reduction in average of pain intensity during migraine attacks (p=0.002) and headache impact test-6 rating (p<0.001) and intake of rescue medication (p<0.001) has been shown. All patients showed good compliance levels and no relevant adverse events.

Larger studies with longer follow up included in table 2.

Satnak M, Wolf S, Jagos H et al. (2020) The impact of external trigeminal nerve stimulator (e-TNS) on prevention and acute treatment of episodic and chronic migraine: A systematic review. Journal of the Neurological Sciences, 412: 116725, 1-13.

Systematic review

external trigeminal nerve stimulator (eTNS) for the prevention and acute treatment of migraine attacks in patients with episodic and chronic migraine.

2 RCTs and 5 prospective case series.

Concerning prevention, statistically significant differences were found with respect to reduction of migraine attacks (0.67 less migraine attacks per month), migraine days (1.74 less migraine days per month), headache days (2.28 less headache days per month), and acute antimigraine drug intake (4.24 less instances of acute drug intake per month). Concerning acute treatment, statistically significant differences were found with respect to pain reduction on a VAS at 1/2/24 h post-acute treatment (1.68/1.02/1.08 improvement, respectively).

No serious adverse events occurred in any of the studies.

Primary studies in the review already included in table 2.

Solomon S Guglielmo KM (1985) Treatment of headache by transcutaneous electrical stimulation. Headache 25 (1): 12-5

General review

Tassorelli C, Diener HC, Silberstein SD et al. (2021) Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine.

Cephalalgia;41(11-12):1135-1151.

Expert analysis by the Clinical Trials Committee of the International Headache Society

on clinical trials involving neuromodulation devices.

Key terms were defined, and recommendations provided relative to the assessment of neuromodulation devices for acute treatment for adults, preventive treatment in adults, and acute and preventive treatment in children and adolescents. Ethical and administrative responsibilities were outlined, and a bibliography of previous research involving neuromodulation devices was created.

Adoption of these recommendations will improve the about of evidence about this important area in migraine treatment.

New guideline for clinical trials of neuromodulation devices for the acute or preventive treatment of migraine.

Vikelis M, Dermitzakis EV, Spingos KC et al. (2017) Clinical experience with transcutaneous supraorbital nerve stimulation in patients with refractory migraine or with migraine and intolerance to topiramate: a prospective exploratory clinical study, BMC Neurol. 17 (1), 97.

Case series

n=37 patients with episodic or chronic migraine refractory or intolerant to treatment needing Cefaly tSNS for prevention (20 minutes/day)

Follow up: 90 days

A small but statistically significant decline was shown in the number of days with headache, the number of days with HA with intensity ≥5/10, and the number of days with use of acute medication after 3 months (p<0.001 for all). 23 patients (65.7%) were satisfied and intent to continue treatment. Compliance was higher among satisfied patients.

Larger studies with longer follow up included in table 2.