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Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

Not Applicable
Completed
Conditions
No Condition Salivary Alpha Amylase
Registration Number
NCT03854539
Lead Sponsor
Arkansas Tech University
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Healthy individuals
Exclusion Criteria
  • NA

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in Salivary Alpha Amylase concentration.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
NameTimeMethod
Change in Heart Rate Variability.Within single one hour session change in heart rate variability immediately prior to and following stimulation period.

Change in beat to beat interval.

Trial Locations

Locations (1)

Arkansas Tech University

🇺🇸

Russellville, Arkansas, United States

Arkansas Tech University
🇺🇸Russellville, Arkansas, United States

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