Pupillometry and Locus Coeruleus Activation (PuLCA)

NCT ID: NCT04579653

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-22

Study Completion Date

2023-11-24

Brief Summary

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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

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Conditions

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Visual Impairment Ocular Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study has a within-subjects design with a randomization of the order of tVNS administered parameters
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group A: Experimental

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

Group Type EXPERIMENTAL

transcutaneous electrical nerve stimulation devices

Intervention Type DEVICE

electrical stimulation through surface electrodes

Group B: Active Comparator

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

Group Type ACTIVE_COMPARATOR

transcutaneous electrical nerve stimulation devices

Intervention Type DEVICE

electrical stimulation through surface electrodes

Interventions

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transcutaneous electrical nerve stimulation devices

electrical stimulation through surface electrodes

Intervention Type DEVICE

Other Intervention Names

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Digitimer DS7A, Ultima Neo, or InTENSity EX4.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Porges, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201903471

Identifier Type: -

Identifier Source: org_study_id