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Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03854539
Enrollment
100
Registered
2019-02-26
Start date
2018-03-31
Completion date
2020-06-08
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No Condition Salivary Alpha Amylase

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.

Interventions

OTHERTransdermal Vagus Nerve Stimulation

intermittent transdermal stimulation of the aurical vagus

Sponsors

Arkansas Tech University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy individuals

Exclusion criteria

* NA

Design outcomes

Primary

MeasureTime frameDescription
Change in Salivary Alpha Amylase concentration.Within single one hour session change in concentration immediately prior to and following stimulation and 5 minutes post-stimulationBiomarker of autonomic arousal level

Secondary

MeasureTime frameDescription
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026