Stroke Clinical Trial - tVNS Responsiveness Testing With Pupil Size

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Participants will wear surface electrodes on the outer ear on both sides and a finger device that monitors heart rate. The attachment sites are the tragus or the cymba concha (depending on the shape and size of the ear) for tVNS and the ear lobe for sham. The electrical current will have a pulse duration of 0.1 ms at 30 Hz with an intensity below the pain threshold or 5 milliamp, whichever is lower, for a duration of 0.5 s. The experimental stimulation intensity will be determined as just below the pain threshold. Participants will receive multiple blocks of unilateral and bilateral stimulations to the sham or tVNS electrodes at rest, during which their pupil size will be recorded. The order of unilateral/bilateral and sham/tVNS stimulation will be randomized. ;

Study Design

Related Conditions & MeSH terms

Stroke

Clinical Trial Details

NCT number	NCT06335199
Study type	Interventional
Source	Georgia Institute of Technology
Contact	Minoru Shinohara, Ph.D.
Phone	404-894-1030
Email	shinohara@gatech.edu
Status	Not yet recruiting
Phase	N/A
Start date	July 1, 2024
Completion date	April 30, 2025

View Details

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