Pupillometry and Locus Coeruleus Activation (PuLCA)

University of Florida

Status: Withdrawn

Conditions: Ocular Illness; Visual Impairment

Treatments: Device: transcutaneous electrical nerve stimulation devices

Study type: Interventional

Funder types: Other

Identifiers

NCT04579653

IRB201903471

Details and patient eligibility

About

This project will apply non-invasive, trans-cutaneous vagal nerve stimulation using various stimulation parameters to young, healthy adults to find the optimal set of parameters to elicit pupil response.

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fluent English speaker with reading and writing proficiency.

Exclusion criteria

• Participants with significant visual impairment or ocular illness may be excluded at the discretion of the principal investigator.
• Major medical illnesses including severe neurological illness (e.g. stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia)
• Any history of brain surgery, tumor, intracranial metal implantation, pacemakers, or other implanted devices.
• Current (i.e. within 48 hours of the session) prescription medication or over-the-counter medication use.
• Illicit alcohol or drug use. Caffeine (e.g, coffee, energy drinks) consumption prior to the visit.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group A: Experimental

Experimental group

Description:

Within-subjects design with a randomization of the order of tVNS administered parameters

Treatment:

Device: transcutaneous electrical nerve stimulation devices

Group B: Active Comparator

Active Comparator group

Description:

Within-subjects design with a randomization of the order of tVNS administered parameters

Treatment:

Device: transcutaneous electrical nerve stimulation devices