Non-invasive transcutaneous Supraorbital Neurostimulation (tSNS) using Cefaly® device in prevention of primary headaches

Neurol Neurochir Pol. 2017 Mar-Apr;51(2):127-134. doi: 10.1016/j.pjnns.2017.01.004. Epub 2017 Jan 20.


Headaches are one of the most common pain syndromes experienced by adult patients. International Classification of Headache Disorders identifies about 300 different entities. Primary headaches (migraine, tension-type headache, trigeminal autonomic cephalalgias, other primary headaches) has the common occurrence. Although effective treatment of these disorders is possible, it is inefficient or poorly tolerated in some patients. Neuromodulation methods, being element of multimodal treatment, provide an additional treatment option in pharmacotherapy-refractory patients. Both invasive and non-invasive stimulation methods are used. The non-invasive techniques is transcutaneous nerve stimulation using Cefaly® device. In this study, Cefaly® was used as prevention treatment in patients with pharmacotherapy-refractory headaches. This device is indicated for the prophylactic treatment of episodic primary headaches. A total of 91-patients (30 without and 61 with tSNS) were enrolled in the study, including 60-patients with migraine and 31-patients with other primary headaches. Ten courses of non-invasive peripheral (supraorbitral/supratrochlear) nerves stimulation were delivered to 57-patients; in the remaining 4 patients, the treatment was abandoned due to poor tolerance. Patients were observed for 30 days after stimulation treatment. Compared to the pre-treatment period, the reduction in the intensity of pain was observed in both the migraine group and patients with other types of headaches; this included the number of pain episodes being reduced by half, with simultaneous reduction in average pain intensity and duration of individual pain episodes. The subjective assessment of pain reduction was in the range of 40-47%. Based on our data we recommend tSNS as useful tool in the prophylaxis of primary headaches, including migraine.

Keywords: Headaches; Neurostimulation; Pharmacotherapy; Transcutaneous nerve stimulation.

MeSH terms

  • Adult
  • Aged
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Headache Disorders, Primary / prevention & control*
  • Humans
  • Male
  • Middle Aged
  • Migraine Disorders / prevention & control*
  • Pain Measurement
  • Patient Acceptance of Health Care
  • Secondary Prevention
  • Transcutaneous Electric Nerve Stimulation / instrumentation*
  • Treatment Outcome
  • Young Adult