Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335199
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-03-15
Brief Title:
tVNS Responsiveness Testing With Pupil Size
Sponsor:
Georgia Institute of Technology
Organization:
Georgia Institute of Technology
Study Overview
Official Title:
Movement-Associated tVNS and Responsiveness Testing for Personalized Rehabilitation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 01 ms at 30 Hz with an intensity below the pain threshold or 5 milliamp whichever is lower for a duration of 05 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 unilateralbilateral and shamtVNS stimulation will be randomized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P2CHD086844-09 | NIH | None | httpsreporternihgovquickSearch5P2CHD086844-09 |