COMPLETED

tVNS Responsiveness Testing With Pupil Size

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Movement-Associated tVNS and Responsiveness Testing for Personalized Rehabilitation

Quick Facts

Study Start:2024-11-14

Study Completion:2025-10-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06335199

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.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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 * 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

Inclusion Criteria

Exclusion 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.

* 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
* 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

Contacts and Locations

Principal Investigator

Minoru Shinohara, Ph.D.

PRINCIPAL_INVESTIGATOR

Georgia Institute of Technology

Study Locations (Sites)

Human Neuromuscular Physiology Lab

Atlanta, Georgia, 30318

United States

Collaborators and Investigators

Sponsor: Georgia Institute of Technology

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-14

Study Completion Date2025-10-27

Study Record Updates

Study Start Date2024-11-14

Study Completion Date2025-10-27

Terms related to this study

Additional Relevant MeSH Terms

Stroke