Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

Conditions
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No Condition Salivary Alpha Amylase

Intervention / Treatment
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* Other: Transdermal Vagus Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy individuals Exclusion Criteria: NA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Stimulation 0.5<br>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<br>* intermittent transdermal stimulation of the aurical vagus<br>|
| Sham Comparator: Sham Stimulation<br>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<br>* intermittent transdermal stimulation of the aurical vagus<br>|
| No Intervention: No Stimulation<br>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<br>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<br>* intermittent transdermal stimulation of the aurical vagus<br>|
| Experimental: Active Stimulation 0.25<br>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<br>* intermittent transdermal stimulation of the aurical vagus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Salivary Alpha Amylase concentration. | 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. | Change in beat to beat interval. | Within single one hour session change in heart rate variability immediately prior to and following stimulation period. |