Pupillometry and Locus Coeruleus Activation (PuLCA)

Visual Impairment Clinical Trial

— PuLCA  

Official title:

Effects of Various Non-invasion Stimulation Parameters on Pupil Dilation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04579653
• Other study ID #: IRB201903471
• Status: Withdrawn
• Phase: N/A
• Start date: November 22, 2023
• Est. completion date: November 24, 2023

Study information

• Verified date: December 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 24, 2023
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ocular Illness
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Device:
• transcutaneous electrical nerve stimulation devices
electrical stimulation through surface electrodes

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular response after transcutaneous nerve stimulation	Number of participants with pupil response after transcutaneous nerve stimulation	Visit 1 day