NCT03854539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

2.2 years

First QC Date

April 19, 2018

Last Update Submit

June 16, 2020

Conditions

No Condition Salivary Alpha Amylase

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Heart Rate Variability.

    Within single one hour session change in heart rate variability immediately prior to and following stimulation period.

Study Arms (5)

Active Stimulation 0.5

EXPERIMENTAL

0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles

Other: Transdermal Vagus Nerve Stimulation

Sham Stimulation

SHAM COMPARATOR

0.5mA intermittent transdermal stimulation of the aurical vagus stimulation5 Hz 30 seconds on/30 seconds off for five cycles

Other: Transdermal Vagus Nerve Stimulation

No Stimulation

NO INTERVENTION

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

0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles.

Other: Transdermal Vagus Nerve Stimulation

Active Stimulation 0.25

EXPERIMENTAL

0.25 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles

Other: Transdermal Vagus Nerve Stimulation

Interventions

Transdermal Vagus Nerve StimulationOTHER

intermittent transdermal stimulation of the aurical vagus

Active Stimulation 0.25Active Stimulation 0.5Active Stimulation 1.0Sham Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Tech University

Russellville, Arkansas, 72801, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 19, 2018

First Posted

February 26, 2019

Study Start

March 31, 2018

Primary Completion

June 8, 2020

Study Completion

June 8, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations

US(1)