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Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05870527
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The research team will evaluate pupillary dilation from vagal nerve stimulation of Arnold's Nerve, a branch of the vagus nerve, during routine cochlear implantation surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: Electrical stimulator
 N/A

Detailed Description

The objective of this study is to determine if electrical stimulation of Arnold's Nerve, a branch of the vagus nerve, can result in vagal nerve response through the measurement of pupillary dilation

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
Anticipated Study Start Date :
May 22, 2023
Anticipated Primary Completion Date :
May 22, 2024
Anticipated Study Completion Date :
May 22, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vagal Nerve Stimulation during Cochlear Implantation Surgery

Participants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation.

Device: Electrical stimulator
Electrical stimulation will be used to stimulate the Arnold's nerve and measure pupil dilation. The electrical stimulator is part of the standard facial nerve monitoring unit that we utilize in cochlear implantation and will be setup prior to surgery in standard fashion. The device allows for constant current stimulation, with stimulus range between 0-30 mA.
No Intervention: Vagal Nerve Stimulator Implantation

Control cohort undergoing vagal nerve stimulator implantation.

Outcome Measures

Primary Outcome Measures

  1. Pupillary Dilation during Procedure [Day 1 (During procedure - typically 1 hour in duration)]

    Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Patients undergoing cochlear implantation:

  • will be undergoing surgery for a cochlear implant

  • is over the age of 18

  • is willing to participate in the study

Patients undergoing vagal nerve stimulator implantation:

  • will be undergoing implantable vagal nerve stimulation

  • is over the age of 18

  • is willing to participate in the study

Exclusion Criteria:
Patients undergoing cochlear implantation:

  • is under the age of 18

  • has history of prior ear surgery, congenital ear malformation, or cochlear implantation

  • pregnant or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.

  • medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:

  • One vagus nerve

  • Receiving other concurrent forms of brain stimulation

  • Heart arrhythmias or other heart abnormalities

  • Dysautonomias (abnormal functioning of the autonomic nervous system)

  • Lung diseases or disorders (shortness of breath, asthma, etc.)

  • Ulcers (gastric, duodenal, etc.)

  • Vasovagal syncope (fainting)

  • Pre-existing hoarseness

Patients undergoing vagal nerve stimulator implantation:

  • is under the age of 18

  • has history of prior ear surgery, congenital ear malformation, or cochlear implantation

  • pregnant or breastfeeding

  • medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:

  • One vagus nerve

  • Receiving other concurrent forms of brain stimulation

  • Heart arrhythmias or other heart abnormalities

  • Dysautonomias (abnormal functioning of the autonomic nervous system)

  • Lung diseases or disorders (shortness of breath, asthma, etc.)

  • Ulcers (gastric, duodenal, etc.)

  • Vasovagal syncope (fainting)

  • Pre-existing hoarseness

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: J. Thomas Roland Jr., NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05870527
Other Study ID Numbers:
  • 23-00248
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hearing Loss
Mydriasis

Study Results

No Results Posted as of May 23, 2023