tVNS Responsiveness Testing With Pupil Size

Description

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

Stroke

Study Overview

Study Details

Study overview

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.

Movement-Associated tVNS and Responsiveness Testing for Personalized Rehabilitation

tVNS Responsiveness Testing With Pupil Size

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Atlanta

Human Neuromuscular Physiology Lab, Atlanta, Georgia, United States, 30318

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18-60 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.
  • * Younger than 18 years old or older than 60 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
  • * Younger than 18 years old or older than 60 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 right upper extremity (UE)
  • * No residual UE voluntary movement
  • * A first stroke less than 4 months prior to the participation
  • * Hemorrhagic stroke
  • * Cerebellar stroke
  • * Serious uncontrolled medical conditions
  • * Severe apraxia of speech
  • * Excessive pain in any joint of the more affected extremity
  • * Receiving any anti-spasticity drugs orally at the time of expected participation, 3 months prior, or wish to or is scheduled to receive injections prior to study completion
  • * Received phenol injections less than 12 months prior to receiving therapy
  • * 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
  • * A score outside of 19-55 on the upper limb portions of the Fugl Meyer Assessment.
  • * Clinical judgment of excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.)
  • * Serious uncontrolled medical conditions
  • * Excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention, as judged by the examining clinician

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Georgia Institute of Technology,

Minoru Shinohara, Ph.D., PRINCIPAL_INVESTIGATOR, Georgia Institute of Technology

Study Record Dates

2025-04-30