Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

NYU Langone Health

Status: Invitation-only

Conditions: Hearing Loss

Treatments: Device: Electrical stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT05870527

23-00248

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Vagal Nerve Stimulation during Cochlear Implantation Surgery

Experimental group

Description:

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

Treatment:

Device: Electrical stimulator

Vagal Nerve Stimulator Implantation

No Intervention group

Description:

Control cohort undergoing vagal nerve stimulator implantation.