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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Stimulation 0.5 | Experimental | 0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles |
|
| Sham Stimulation | Sham Comparator | 0.5mA intermittent transdermal stimulation of the aurical vagus stimulation5 Hz 30 seconds on/30 seconds off for five cycles |
|
| No Stimulation | No Intervention | 0.0 mA (sham) intermittent transdermal stimulation of the aurical vagus stimulation, 0 Hz 30 seconds on/30 seconds off for five cycles | |
| Active Stimulation 1.0 | Experimental | 0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles. |
|
| Active Stimulation 0.25 | Experimental | 0.25 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal Vagus Nerve Stimulation | Other | intermittent transdermal stimulation of the aurical vagus |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Tech University | Russellville | Arkansas | 72801 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 27, 2020 | |
| Reset | Sep 15, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 27, 2020 | Sep 15, 2020 |
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