Pupillometry and Locus Coeruleus Activation (PuLCA)

Not Applicable

Withdrawn

• Conditions: Ocular Illness; Visual Impairment
• Interventions: Device: transcutaneous electrical nerve stimulation devices

• Registration Number: NCT04579653
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-08
• Study Start: 2023-11-22
• Primary Completion: 2023-11-23
• Study Completion: 2023-11-24
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: Active Comparator	transcutaneous electrical nerve stimulation devices	Within-subjects design with a randomization of the order of tVNS administered parameters
Group A: Experimental	transcutaneous electrical nerve stimulation devices	Within-subjects design with a randomization of the order of tVNS administered parameters

Primary Outcome Measures

Name	Time	Method
Ocular response after transcutaneous nerve stimulation	Visit 1 day	Number of participants with pupil response after transcutaneous nerve stimulation

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States