Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

June 16, 2020 updated by: Rodney Roosevelt, Arkansas Tech University
The proposed project tests the hypothesis that salivary alpha amylase concentration is a reliable biomarker of the effect of transdermal vagus nerve stimulation (tVNS) in humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study examines the capacity of tVNS to alter the concentrations of salivary alpha amylase. Changes in salivary alpha amylase concentrations reflect alteration of CNS structures anatomically linked to the vagus, thus alertation of alpha amylase would indicate the efficacy of tVNS. This study is intended to study basic mechanisms and is not directed toward the treatment of any disease state. Particapants taking part in the study will spend about one hour in a single session.

Study Type

Interventional

Enrollment (Actual)

100

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

  • United States
    • Arkansas
      • Russellville, Arkansas, United States, 72801
        • Arkansas Tech University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy individuals

Exclusion Criteria:

  • NA

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Stimulation 0.5
0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles
Other: Transdermal Vagus Nerve Stimulation
intermittent transdermal stimulation of the aurical vagus
Sham Comparator: Sham Stimulation
0.5mA intermittent transdermal stimulation of the aurical vagus stimulation5 Hz 30 seconds on/30 seconds off for five cycles
Other: Transdermal Vagus Nerve Stimulation
intermittent transdermal stimulation of the aurical vagus
No Intervention: No Stimulation
0.0 mA (sham) intermittent transdermal stimulation of the aurical vagus stimulation, 0 Hz 30 seconds on/30 seconds off for five cycles
Experimental: Active Stimulation 1.0
0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles.
Other: Transdermal Vagus Nerve Stimulation
intermittent transdermal stimulation of the aurical vagus
Experimental: Active Stimulation 0.25
0.25 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles
Other: Transdermal Vagus Nerve Stimulation
intermittent transdermal stimulation of the aurical vagus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Salivary Alpha Amylase concentration.
Time Frame: Within single one hour session change in concentration immediately prior to and following stimulation and 5 minutes post-stimulation
Biomarker of autonomic arousal level
Within single one hour session change in concentration immediately prior to and following stimulation and 5 minutes post-stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability.
Time Frame: Within single one hour session change in heart rate variability immediately prior to and following stimulation period.
Change in beat to beat interval.
Within single one hour session change in heart rate variability immediately prior to and following stimulation period.

Collaborators and Investigators

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

Sponsor

Arkansas Tech University

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)

March 31, 2018

Primary Completion (Actual)

June 8, 2020

Study Completion (Actual)

June 8, 2020

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Roosevelt-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on No Condition Salivary Alpha Amylase

Clinical Trials on Transdermal Vagus Nerve Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe