CompletedNot Applicable

Effects of the Ultra-low Frequencies TENS on the Arousal Circuits

Italy40 participantsStarted 2024-09-24

Plain-language summary

Pupil size is associated with the activity of the noradrenergic system, with an increase reflecting a higher state of arousal. Transmucosal electrical stimulation of the tongue could treat disorders related to dysfunctions of this system, and trigeminal stimulation through ULFTENS (TUD) has shown some positive effects. However, no studies have examined the effect of stimulation of the anterior mucosa of the tongue on pupil size as an indicator of arousal. The aim of this study will be to evaluate the effect of ULFTENS stimulation on pupil size in the dark.

Who can participate

Age range20 Years – 30 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * good health status and physical fitness * female sex * age between 20 and 30 years * non-smoker * no more than 3 espresso coffees per day * no intake of stimulant or psychotropic drugs in general * body mass index between 18.5 and 24.9 Exclusion Criteria: * presence of acute and/or chronic cardiocirculatory and respiratory disorders * metabolic and autonomic system disorders * intake of peripheral and central nervous system excitatory or inhibiting substances * presence of generalized anxiety and/or panic attacks, or mood disorders.

What they're measuring

Pupil size

Timeframe: 12 minutes

Trial details

NCT IDNCT06790459

SponsorUniversity of L'Aquila

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-02

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