Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

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