Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 89 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 18-89 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.

Exclusion Criteria

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 - Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia) - Suspected of pregnancy Post-stroke 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 any implanted devices such as a neurostimulator or cochlear implant - Current or history of tympanic membrane perforation - No persistent hemiparesis on the upper extremity (UE) - No residual UE voluntary movement - A first stroke less than 4 months prior to the participation - Serious uncontrolled medical conditions - Excessive pain in any joint of the more affected extremity - Unable to stand independently for 2 min., transfer independently to and from the toilet or perform sit-to-stand - 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 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 - Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia) - Suspected of pregnancy - A score of less than 24 on the Folstein Mini-Mental State Examination - Excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.) - Excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Unilateral Left tVNS
Electrical stimulation to the vagus nerve area of the outer ear on the left side.
  • 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.
Experimental
Bilateral tVNS
Electrical stimulation to the vagus nerve area of the outer ear on both sides.
  • 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.
Sham Comparator
Unilateral Left Sham
Electrical stimulation to the non-vagus nerve area of the outer ear on the left side.
  • Procedure: Unilateral Left Sham stimulation
    Electrical stimulation to the earlobe of the outer ear on the left side after successful trials.
Sham Comparator
Bilateral Sham
Electrical stimulation to the non-vagus nerve area of the outer ear on both sides.
  • Procedure: Bilateral Sham stimulation
    Electrical stimulation to the earlobe of the outer ear on both sides after successful trials.
Experimental
Unilateral Right tVNS
Electrical stimulation to the vagus nerve area of the outer ear on the right side.
  • 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.
Sham Comparator
Unilateral Right Sham
Electrical stimulation to the non-vagus nerve area of the outer ear on the right side.
  • Procedure: Unilateral Right Sham stimulation
    Electrical stimulation to the earlobe of the outer ear on the right side after successful trials.

Recruiting Locations

Human Neuromuscular Physiology Lab
Atlanta, Georgia 30318
Contact:
Minoru Shinohara, Ph.D.
404-894-1030
shinohara@gatech.edu

More Details

NCT ID
NCT06335199
Status
Recruiting
Sponsor
Georgia Institute of Technology

Study Contact

Minoru Shinohara, Ph.D.
404-894-1030
shinohara@gatech.edu

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.