Stimulator, electrical, analgesic, peripheral nerve, transcutaneous

Intended purpose

Medical device intended for treatment and prevention of migraine and tension headaches, using transcutaneous nerve stimulation (TNS) of the major bifurcation of the trigeminal nerve which runs across the forehead (i.e. supraorbital TNS). The device may also be used to assist relaxation and achieve a sedative effect (Piquet et al. BMC Neurology 2011, 11:135). An external self adhesive electrode (30 mm × 94 mm) is placed on the forehead and is designed in order to cover the supratrochlear and supraorbital nerves bilaterally. The TNS headset is placed over the electrode and is a constant current generator with a maximum skin impedance of 2.2 KOhms, which generates biphasic rectangular impulses with an electrical mean equal to zero. The impulses have an impulse width of 250 microseconds, maximum intensity 14 mA.