tVNS Responsiveness Testing With Pupil Size

Launched by GEORGIA INSTITUTE OF TECHNOLOGY · Mar 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how the size of a person's pupils reacts to a treatment called transcutaneous vagus nerve stimulation (tVNS), which is applied to the outer ear. The researchers want to find out if stimulating both sides of the ear (bilateral tVNS) leads to a bigger change in pupil size compared to stimulating just one side (unilateral tVNS). The trial includes stroke survivors who have some ability to move their affected arm and healthy adults aged 18 to 60.

Participants will receive either the actual treatment or a placebo (a pretend treatment that doesn't have any active effect) while their pupil size is measured. The study is currently looking for volunteers, and those interested should be aware of the specific health conditions that would make them eligible or ineligible to participate. If you or someone you know fits the criteria and is interested, this could be a valuable opportunity to contribute to important research on stroke recovery.

Gender

ALL

Eligibility criteria

• 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