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Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03854539
Recruitment Status : Completed
First Posted : February 26, 2019
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Rodney Roosevelt, Arkansas Tech University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
No Condition Salivary Alpha Amylase Other: Transdermal Vagus Nerve Stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation
Actual Study Start Date : March 31, 2018
Actual Primary Completion Date : June 8, 2020
Actual Study Completion Date : June 8, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individuals

Exclusion Criteria:

  • NA
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854539


Locations
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United States, Arkansas
Arkansas Tech University
Russellville, Arkansas, United States, 72801
Sponsors and Collaborators
Arkansas Tech University
More Information
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Responsible Party: Rodney Roosevelt, Assistant Professor, Arkansas Tech University
ClinicalTrials.gov Identifier: NCT03854539    
Other Study ID Numbers: Roosevelt-1
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

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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