Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

A

Arkansas Tech University

Status

Completed

Conditions

No Condition Salivary Alpha Amylase

Treatments

Other: Transdermal Vagus Nerve Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03854539
Roosevelt-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy individuals

Exclusion criteria

NA

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 5 patient groups

Active Stimulation 0.5
Experimental group
Description:
0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles
Treatment:
Other: Transdermal Vagus Nerve Stimulation
Sham Stimulation
Sham Comparator group
Description:
0.5mA intermittent transdermal stimulation of the aurical vagus stimulation5 Hz 30 seconds on/30 seconds off for five cycles
Treatment:
Other: Transdermal Vagus Nerve Stimulation
No Stimulation
No Intervention group
Description:
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 group
Description:
0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles.
Treatment:
Other: Transdermal Vagus Nerve Stimulation
Active Stimulation 0.25
Experimental group
Description:
0.25 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles
Treatment:
Other: Transdermal Vagus Nerve Stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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