Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Tragus and Tongue Stimulation.

August 7, 2024 updated by: Sara Di Nicolantonio, University of L'Aquila

Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Cutaneous (Tragus) and Tongue (Antero-Dorsal Mucosa) Stimulation.

this study wants to analyse the effect of trigeminal stimulation on Heart rate Variability. There are going to be two groups, in the test group it will be administered stimulation of the tongue with TENS, while in the control goup TENS will be administered at tragus level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study analyses the effect of trigeminal stimulation with TENS on Heart rate variability (HRV). A new intraoral device will be administered on the dorsal surface of the tongue for TENS stimulation in the test group. The RMSSD, LF, HF and LF/HF will be monitered by photoplethysmographic wave. the results obtained with tongue stimulation will be compared with the results obtained in the control group, where it will be administered TENS stimulation at the tragus level. This work sought to assess whether there is a difference in HRV in relation to the site of application of dental ULFTENS (tragus vs tongue).

If effective in reducing the activity of arousal circuits, this tongue-level stimulation technique could have new clinical applications.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • L'Aquila, Italy, 67100
        • Sara Di Nicolantonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy Women
  • Age 18-30 years

Exclusion Criteria:

  • presence of acute and/or chronic cardio-circulatory and respiratory disorders
  • metabolic and autonomic system disorders
  • intake of excitatory or inhibiting substances of the peripheral and central nervous system
  • presence of generalised anxiety and/or panic attacks or mood disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TUD group
an intraoral device will be administered in the TUD group in order to provide the stimulation of the dorsal surface of the tongue with dental TENS. The trial will last approximately 24 minutes, after the first 6 minutes, TENS activation will take place and how HRV values change will be evaluated. The Heart rate Variability parameters will be analysed with photopletismographic wave after 6 minutes of tongue stimulation
Device: device that stimulates the dorsal surface of the tongue
the device will be placed on the dorsal surface of the tongue. this instrument has two electrodes in turn connected to the TENS, so ultra low frequency stimulation (<0.66 Hz) will be administered
Active Comparator: Tragus group
patients in this group will be administered traditional trigeminal stimulation with dental TENS at tragus level. Tens will be turned on for 6 minutes in which the HRV parameters will be analyzed with the photoplethysmograph and compared with the data obtained in the TUD group.
Device: device that stimulates the tragus
two electrodes will be placed at tragus level for the administration of dental ULFTENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on Low Frequency parameter (LF)
Time Frame: 12 minutes
Whether or not HRV parameter (LF) improve following tongue and tragus stimulation will be assessed by photopletismographic wave
12 minutes
Changes on Root mean square standard deviation (RMSSD) parameter
Time Frame: 12 minutes
Whether or not HRV parameter (RMSSD) improve following tongue and tragus stimulation will be assessed by photopletismographic wave
12 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2022

Primary Completion (Actual)

June 24, 2023

Study Completion (Actual)

January 12, 2024

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16137/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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