Pupillometry and Locus Coeruleus Activation (PuLCA) (PuLCA)

December 13, 2023 updated by: University of Florida

Effects of Various Non-invasion Stimulation Parameters on Pupil Dilation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Experimental
Within-subjects design with a randomization of the order of tVNS administered parameters
Device: transcutaneous electrical nerve stimulation devices
electrical stimulation through surface electrodes
Other Names:
  • Digitimer DS7A, Ultima Neo, or InTENSity EX4.
Active Comparator: Group B: Active Comparator
Within-subjects design with a randomization of the order of tVNS administered parameters
Device: transcutaneous electrical nerve stimulation devices
electrical stimulation through surface electrodes
Other Names:
  • Digitimer DS7A, Ultima Neo, or InTENSity EX4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular response after transcutaneous nerve stimulation
Time Frame: Visit 1 day
Number of participants with pupil response after transcutaneous nerve stimulation
Visit 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Eric Porges, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 22, 2023

Primary Completion (Estimated)

November 23, 2023

Study Completion (Estimated)

November 24, 2023

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201903471

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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