Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

Not Applicable

Completed

• Conditions: No Condition Salivary Alpha Amylase
• Interventions: Other: Transdermal Vagus Nerve Stimulation

• 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.

Study Timeline

• Study Start: 2018-03-31
• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-26
• Status Verified: 2020-06
• Primary Completion: 2020-06-08
• Study Completion: 2020-06-08
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Healthy individuals

Exclusion Criteria

• NA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	Transdermal Vagus Nerve Stimulation	0.5mA intermittent transdermal stimulation of the aurical vagus stimulation5 Hz 30 seconds on/30 seconds off for five cycles
Active Stimulation 1.0	Transdermal Vagus Nerve Stimulation	0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles.
Active Stimulation 0.25	Transdermal Vagus Nerve Stimulation	0.25 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles
Active Stimulation 0.5	Transdermal Vagus Nerve Stimulation	0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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