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

NCT06790459 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-24

No results posted yet for this study

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.

Conditions

  • Pupil Diameter
  • Arousal

Interventions

DEVICE

UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)

ULFTENS device will be administered in the experimental group for 15 minutes

Sponsors & Collaborators

  • University of L'Aquila

    lead OTHER

Principal Investigators

  • Annalisa Monaco · University of L'Aquila

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2024-10-02
Completion
2024-10-30

Countries

  • Italy

Study Locations

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Read the full study record

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View NCT06790459 on ClinicalTrials.gov