Pupillometry and Locus Coeruleus Activation (PuLCA)

NCT04579653 | Withdrawn FDA Device

• 1 other identifier: IRB201903471
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Impairment; Ocular Illness

Outcome Measures

Primary Outcomes (1)

• Ocular response after transcutaneous nerve stimulation

  Number of participants with pupil response after transcutaneous nerve stimulation

  Visit 1 day

Study Arms (2)

Group A: Experimental

EXPERIMENTAL

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

Device: transcutaneous electrical nerve stimulation devices

Group B: Active Comparator

ACTIVE COMPARATOR

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

Device: transcutaneous electrical nerve stimulation devices

Interventions

transcutaneous electrical nerve stimulation devices DEVICE

electrical stimulation through surface electrodes

Also known as: Digitimer DS7A, Ultima Neo, or InTENSity EX4.

Group A: Experimental; Group B: Active Comparator

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fluent English speaker with reading and writing proficiency.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Porges, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study has a within-subjects design with a randomization of the order of tVNS administered parameters

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: October 8, 2020
• Study Start: November 22, 2023
• Primary Completion: November 23, 2023
• Study Completion: November 24, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

US (1)