NCT06335199Completed
tVNS Responsiveness Testing With Pupil Size
Movement-Associated tVNS and Responsiveness Testing for Personalized Rehabilitation
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 15 Mar 2024
- Start date
- 14 Nov 2024
- Primary completion date
- 27 Oct 2025
- Lead sponsor
- Georgia Institute of Technology
- Diseases
- Stroke
- NCT number
- NCT06335199
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 14 Nov 2024 to the primary completion date, 27 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have an implanted device such as a neurostimulator or cochlear implant
- Had a head injury or brain surgery
- Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metal work
- Have any implanted devices such as a neurostimulator or cochlear implant
- A first stroke less than 4 months prior to the participation
- Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metal work
Other illness
- Current or history of cardiac disease
- Current or history of tympanic membrane perforation
- Had a stroke or lesion (including tumor) in your brain
- 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)
- Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia)
- Suspected of pregnancy
- Post-stroke subjects:
- Current or history of cardiac disease
- Current or history of tympanic membrane perforation
- Serious uncontrolled medical conditions
- 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)
- Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia)
Age
- Younger than 18 years old or older than 89 years old
- Younger than 18 years old or older than 89 years old
Other
- Able-bodied subjects:
- Have a vision problem not corrected by glasses or contact lenses
- Suffer from frequent or severe headaches
- Had a fainting spell or syncope
- Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion
- Have a vision problem not corrected by glasses or contact lenses
- No persistent hemiparesis on the upper extremity (UE)
- No residual UE voluntary movement
- 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
- Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 89 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Human Neuromuscular Physiology Lab Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.