Abstract
BackgroundTranscutaneous 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.MethodsWe 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.ResultsAs 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.ConclusionSupraorbital 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.
Highlights
Transcutaneous neurostimulation (TNS) at extracephalic sites is a well known treatment of pain
The utility of TNS in the treatment and prevention of headaches and migraine has been investigated [15] and several clinical trials are underway. Subjects enrolled in those trials have repeatedly reported that supraorbital TNS tended to affect vigilance and decrease attention with a tendency to fall asleep during the stimulation
Each subject was tested in 4 different experimental conditions: without neurostimulation device, with a sham neurostimulation (Sham control: SC), with a low frequency neurostimulation (LFN) and with a high frequency neurostimulation (HFN)
Summary
Transcutaneous neurostimulation (TNS) at extracephalic sites is a well known treatment of pain. Neurostimulation is a therapeutic method where action potentials are elicited by depolarizing nerve fibres with electrical impulses produced by a current generator device generally called neurostimulator This method is used percutaneously with implantable neurostimulators and electrodes positioned over the spinal cord or peripheral nerves, or transcutaneously via superficial skin electrodes and external neurostimulators. Transcutaneous neurostimulation (TNS) is a classical technique which has demonstrated its efficacy in the treatment of pain [12,13] and is nowadays largely in use in pain clinics and physical therapy centres. It has the advantage of being non-invasive, safe and almost devoid of adverse effects contrary to PNS which needs a surgical intervention to implant the electrodes and the neurostimulator. Subjects enrolled in those trials have repeatedly reported that supraorbital TNS tended to affect vigilance and decrease attention with a tendency to fall asleep during the stimulation
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