tVNS Responsiveness Testing With Pupil Size

NCT06335199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-10-29

No results posted yet for this study

Summary

The goal of this study is to learn about the acute pupil response to transcutaneous vagus nerve stimulation (tVNS) in stroke survivors and healthy adults. The main question it aims to answer is whether pupil size response is greater with bilateral tVNS compared to unilateral tVNS. Participants will receive tVNS and sham at the outer ear unilaterally and bilaterally in resting condition. The pupil size of the participants will be recorded during tVNS.

Conditions

Interventions

PROCEDURE

Bilateral Sham stimulation

Electrical stimulation to the earlobe of the outer ear on both sides after successful trials.

PROCEDURE

Unilateral Right tVNS stimulation

Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on the right side after successful trials.

PROCEDURE

Unilateral Right Sham stimulation

Electrical stimulation to the earlobe of the outer ear on the right side after successful trials.

PROCEDURE

Unilateral Left tVNS stimulation

Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on the left side after successful trials.

PROCEDURE

Bilateral tVNS stimulation

Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on both sides after successful trials.

PROCEDURE

Unilateral Left Sham stimulation

Electrical stimulation to the earlobe of the outer ear on the left side after successful trials.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Georgia Institute of Technology

    lead OTHER

Principal Investigators

  • Minoru Shinohara, Ph.D. · Georgia Institute of Technology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-14
Primary Completion
2025-10-27
Completion
2025-10-27

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06335199 on ClinicalTrials.gov