Supraorbital transcutaneous neurostimulation has sedative effects in healthy subjects.
BACKGROUND
Transcutaneous neurostimulation (TNS) at extracephalic sites is a well known treatment of pain. Thanks to recent technical progress, the Cefaly® device now also allows supraorbital TNS. During observational clinical studies, several patients reported decreased vigilance or even sleepiness during a session of supraorbital TNS. We decided therefore to explore in more detail the potential sedative effect of supraorbital TNS, using standardized psychophysical tests in healthy volunteers.


METHODS
We performed a double-blind cross-over sham-controlled study on 30 healthy subjects. They underwent a series of 4 vigilance tests (Psychomotor Vigilance Task, Critical Flicker Fusion Frequency, Fatigue Visual Numeric Scale, d2 test). Each subject was tested under 4 different experimental conditions: without the neurostimulation device, with sham supraorbital TNS, with low frequency supraorbital TNS and with high frequency supraorbital TNS.


RESULTS
As judged by the results of three tests (Psychomotor Vigilance Task, Critical Flicker Fusion Frequency, Fatigue Visual Numeric Scale) there was a statistically significant (p < 0.001) decrease in vigilance and attention during high frequency TNS, while there were no changes during the other experimental conditions. Similarly, performance on the d2 test was impaired during high frequency TNS, but this change was not statistically significant.


CONCLUSIONS
Supraorbital high frequency TNS applied with the Cefaly® device decreases vigilance in healthy volunteers. Additional studies are needed to determine the duration of this effect, the underlying mechanisms and the possible relation with the stimulation parameters. Meanwhile, this effect opens interesting perspectives for the treatment of hyperarousal states and, possibly, insomnia.
Environmental, Occupational and Ageing Physiology Laboratory, DAN Europe Research, Haute Ecole Paul Henri Spaak, I.S.E.K., Brussels, Belgium. pimax45@hotmail.fr
Maxime
M
Piquet
Costantino
C
Balestra
Simona L
SL
Sava
Jean E
JE
Schoenen
D000328:Adult; D001143:Arousal / Q000502:physiology*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests; D055815:Young Adult