NCT07528742

Brief Summary

Non-Invasive Vagus Nerve Stimulation will be provided to the participants using a transcutaneous electrical nerve stimulation (TENS) unit, a routine physical therapy intervention by the faculty researcher who is a licensed physical therapist. The electrodes will be clipped to ear over the vagus nerve distribution area. The parameters will be 30 Hz, 250 us, 5 minutes, at tolerance (no pain). Reaction time will test collected pre and post the stimulation using online reaction time testing platform.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress9%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

April 4, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 4, 2026

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reaction time

    Reaction time will test collected pre and post the stimulation using online platform. The subjects will press a key when setting a color change in the computer screen.

    Baseline and immediately after the intervention.

Study Arms (1)

vagus nerve stimulation

EXPERIMENTAL

Non-Invasive Vagus Nerve Stimulation will be provided to the participants using a transcutaneous electrical nerve stimulation (TENS) unit, a routine physical therapy intervention by the faculty researcher who is a licensed physical therapist. The electrodes will be clipped to ear over the vagus nerve distribution area. The parameters will be 30 Hz, 250 us, 5 minutes, at tolerance (no pain).

Device: vagus nerve stimulation

Interventions

Non-Invasive Vagus Nerve Stimulation will be provided to the participants using a transcutaneous electrical nerve stimulation (TENS) unit, a routine physical therapy intervention by the faculty researcher who is a licensed physical therapist. The electrodes will be clipped to ear over the vagus nerve distribution area. The parameters will be 30 Hz, 250 us, 5 minutes, at tolerance (no pain)

vagus nerve stimulation

Eligibility Criteria

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

You may qualify if:

  • Healthy participants over the age of 18
  • did not receive vagus nerve stimulation previously

You may not qualify if:

  • alcohol or drug abuse
  • metal in the skull
  • implanted cardiac or cranial devices
  • Women during 3 trimester of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555, United States

RECRUITING

Related Publications (1)

  • Camargo L, Gianlorenco AC, Pacheco-Barrios K, Pichardo E, Costa V, Choi H, Song JJ, Fregni F. The effects of non-invasive transcutaneous auricular vagus nerve stimulation on resting-state delta oscillation: a randomized, double-blinded, sham-control trial. Sci Rep. 2025 Oct 3;15(1):34531. doi: 10.1038/s41598-025-17821-5.

MeSH Terms

Interventions

Vagus Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Central Study Contacts

Weiqing Ge Ge, DPT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 14, 2026

Study Start

April 6, 2026

Primary Completion (Estimated)

April 5, 2027

Study Completion (Estimated)

April 5, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The investigators plan to present at conference and publish in scientific journal.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
One year.

Locations