Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

No Condition Salivary Alpha Amylase Clinical Trial

Official title:

Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03854539
• Other study ID #: Roosevelt-1
• Status: Completed
• Phase: N/A
• Start date: March 31, 2018
• Est. completion date: June 8, 2020

Study information

• Verified date: June 2020
• Source: Arkansas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 8, 2020
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy individuals

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• No Condition Salivary Alpha Amylase

Intervention

Other:
• Transdermal Vagus Nerve Stimulation
intermittent transdermal stimulation of the aurical vagus

Locations

Country	Name	City	State
United States	Arkansas Tech University	Russellville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.