tVNS Responsiveness Testing With Pupil Size
Movement-Associated tVNS and Responsiveness Testing for Personalized Rehabilitation
2 other identifiers
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 28, 2024
CompletedStudy Start
First participant enrolled
November 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2025
CompletedOctober 29, 2025
March 1, 2025
12 months
March 15, 2024
October 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Pupil size change
Acute change in pupil size in response to electrical stimulation, relatively expressed as a percent change from the baseline
Day 1
Study Arms (6)
Unilateral Left tVNS
EXPERIMENTALElectrical stimulation to the vagus nerve area of the outer ear on the left side.
Bilateral tVNS
EXPERIMENTALElectrical stimulation to the vagus nerve area of the outer ear on both sides.
Unilateral Left Sham
SHAM COMPARATORElectrical stimulation to the non-vagus nerve area of the outer ear on the left side.
Bilateral Sham
SHAM COMPARATORElectrical stimulation to the non-vagus nerve area of the outer ear on both sides.
Unilateral Right tVNS
EXPERIMENTALElectrical stimulation to the vagus nerve area of the outer ear on the right side.
Unilateral Right Sham
SHAM COMPARATORElectrical stimulation to the non-vagus nerve area of the outer ear on the right side.
Interventions
Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on the left side after successful trials.
Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on both sides after successful trials.
Electrical stimulation to the earlobe of the outer ear on the left side after successful trials.
Electrical stimulation to the earlobe of the outer ear on both sides after successful trials.
Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on the right side after successful trials.
Electrical stimulation to the earlobe of the outer ear on the right side after successful trials.
Eligibility Criteria
You may qualify if:
- years old across all races, genders, and ethnicities.
- Post-stroke subjects will have persistent hemiparesis on the upper extremity (UE) with some residual UE voluntary movement.
You may not qualify if:
- Able-bodied subjects:
- Younger than 18 years old or older than 89 years old
- Current or history of cardiac disease
- Have a vision problem not corrected by glasses or contact lenses
- Have an implanted device such as a neurostimulator or cochlear implant
- Current or history of tympanic membrane perforation
- Had a stroke or lesion (including tumor) in your brain
- Had a head injury or brain surgery
- Suffer from frequent or severe headaches
- Had a fainting spell or syncope
- Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metal work
- Have any implanted device such as cardiac pacemakers, medical pumps, or intra-cardiac lines
- Had any brain-related conditions (i.e. multiple sclerosis, Parkinson, Alzheimer)
- Had any illness that caused brain injury (i.e. meningitis, aneurysm, brain tumor)
- Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Human Neuromuscular Physiology Lab
Atlanta, Georgia, 30318, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Minoru Shinohara, Ph.D.
Georgia Institute of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2024
First Posted
March 28, 2024
Study Start
November 14, 2024
Primary Completion
October 27, 2025
Study Completion
October 27, 2025
Last Updated
October 29, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data will become available after the publication of all papers from the study.
- Access Criteria
- The scientific data will be made available by a data repository after approval.
De-identified individual participant data on pupil size change will be available to other researchers outside the primary research group.