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

Safety summary

Minor adverse events

Mild and transient adverse events were reported in 6% (3/51) of people in the tSNS group, 35% (18/51) of people in the flunarizine group and 37% (19/51) of people in the tSNS plus flunarizine group in the RCT of 165 people. The rate of adverse effects in the tSNS alone group was statistically significantly lower than that in tSNS plus flunarizine group (p<0.001), but there was no statistically significant difference between flunarizine alone and tSNS plus flunarizine (p=0.89; Jiang 2019).

One or more adverse events (minor and reversible) were reported in 4% (99/2,313) of people in the case series of 2,313 people. Some people reported more than 1 event (Magis 2015).

Intolerance to paraesthesia

Uncomfortable paraesthesia (various forehead sensations including burning, itching, tingling, stinging and numbness) was reported in 25% (15/59) of people in the case series of 59 people. Four people were unable to complete the treatment session (Kuruvilla 2019). Forehead paraesthesia, discomfort and burning were statistically significantly higher in the eTNS group (4% [9/259]) than sham group in the RCT of 538 patients (less than 1% [1/279], p<0.009k; Kuruvilla 2022).

Discomfort paraesthesia during stimulation was reported in 13% (6/45) of people in the STNS group and none in the PMES group in the RCT of 90 people (p=0.026). Two of these people stopped treatment because of intolerance of stimulation sensations (Deng 2020).

Forehead paraesthesia was reported in 3 people (1 in tSNS group and 2 in the tSNS plus flunarizine group) in the RCT of 165 people (Jiang 2019).

Local pain or intolerance to paraesthesia induced by the electrical stimulation was reported in 2% (47/2,313) of people in the case series of 2,313 people. All people stopped the treatment (Magis 2015).

Paraesthesia sensation during stimulation (not tolerable) was reported in 2 people in the eTNS group and in 1 person in the sham stimulation group in the RCT of 106 people. The stimulation was stopped within 5 minutes (Chou 2019).

Discomfort (in 1 person) and tingling (in 1 person) at the stimulation site was reported in the case series of 100 people (Danno 2019). Strong stimulation was reported in 1 person who dropped out from the study.

Skin problems

Skin problems were reported in less than 1% (9/2,313) of people in the case series of 2,313 people. These included transient local skin allergy in 2 people, reversible forehead skin irritation in 5 people, and a feeling of bruising on the forehead in 2 people (Magis 2015).

Skin allergy at the electrode contact site was reported in 1 person in the tSNS plus flunarizine group in the RCT of 165 people (Jiang 2019).

Skin irritation at the electrode contact site (for up to 30 minutes) was reported in 4 people in the tSNS group (n=61) in the RCT of 91 people (Przeklasa-Muszynska 2017).

Skin irritation under the electrode on the forehead was reported in 1 person in the case series of 73 people. They stopped using the device (Birlea 2019).

Headache after a session

Tension-type headache was reported in less than 1% (12/2,313) of people in the case series of 2,313 people (Magis 2015).

Headache worsening with vertigo was reported in 1 person in the case series of 73 people (Birlea 2019).

Headache was reported in 1 person in the case series of 100 people (Danno 2019).

Nausea

Nausea during stimulation that resolved without treatment after 20 minutes was reported in 1 person in the eTNS group and none in the sham stimulation group in the RCT of 106 people (Chou 2019).

Nausea and vomiting were reported in 4 patients in the eTNS group (n=259) in the RCT of 538 patients (Kuruvilla 2022).

Arousal and sleep changes

Somnolence was reported in 1 person in the tSNS group, 9 people in the flunarizine group and 12 people in the tSNS plus flunarizine group in the RCT of 165 people (Jiang 2019).

Arousal and sleep changes were reported in less than 1% (19/2,313) of people in the case series of 2,313 people. These included insomnia in 4 people, fatigue in 3 people and sleepiness in 12 people (Magis 2015).

Sleepiness (in 2 people) and fatigue (in 1 person) were reported in the case series of 100 people. Two of these people dropped out of the study before the treatment period (Danno 2019).

Weakness in jaw muscles and upper extremities

Weakness in jaw muscles and in upper and lower extremity muscles was reported in 1 person 17 minutes after starting the device on the lowest setting. They also developed significant dizziness. These symptoms increased until the use of the device was stopped. After stopping the device, the muscle weakness and dizziness took about 2 hours to resolve completely. This adverse event was reported in the FDA MAUDE database by a physician (FDA MAUDE database 2014).