What is the mechanism of action of this treatment?

Common treatments for hearing loss, particularly those involving neuromodulation like vagal nerve stimulation (VNS), work by targeting the neural pathways associated with auditory processing. VNS, for example, involves stimulating the vagus nerve to modulate brain activity, which can potentially improve auditory function and reduce symptoms like tinnitus. This matters for hearing loss patients because such treatments aim to address the underlying neural dysfunctions that contribute to hearing loss, offering a non-invasive alternative to traditional hearing aids or surgical interventions. By improving neural plasticity and reducing maladaptive neural activity, these treatments can enhance auditory perception and overall quality of life for patients.

What side effects are associated with this type of intervention?

Common treatments for hearing loss include cochlear implants, hearing aids, and neuromodulation techniques such as Vagal Nerve Stimulation (VNS). VNS, specifically, has been studied for its potential to improve tinnitus perception in patients with epilepsy, with some patients reporting subjective improvement. However, side effects of VNS can include voice changes, throat pain, cough, and shortness of breath. Cochlear implants, another treatment for severe hearing loss, can lead to side effects such as dizziness, tinnitus, and surgical risks like infection. Hearing aids generally have fewer side effects but can cause discomfort and skin irritation.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments of hearing loss that are similar to Vagal Nerve Stimulation (VNS) or stimulation of Arnold's Nerve. However, cochlear implants are a well-established treatment for severe hearing loss and have been approved by the FDA. These devices work by directly stimulating the auditory nerve, which is somewhat related to the concept of nerve stimulation seen in VNS. Other treatments for hearing loss include hearing aids and various surgical interventions for conductive hearing loss.

What other types of research exist?

Promising novel alternatives to Vagal Nerve Stimulation for hearing loss patients include: 1) Intracochlear near-infrared (NIR) stimulation, which may be useful in combined electro-acoustic stimulation devices. 2) Neuronavigated repetitive transcranial magnetic stimulation (rTMS), which has shown potential in treating auditory phantom perceptions like chronic tinnitus. 3) Cochlear implantation, which has been effective in tinnitus suppression and improving auditory function.

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Vagal Nerve Stimulation for Dilated Pupil

N/A

Waitlist Available

Led By J. Thomas Roland Jr.

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing cochlear implantation: is over the age of 18

Patients undergoing cochlear implantation: will be undergoing surgery for a cochlear implant

Must not have

medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following: Lung diseases or disorders (shortness of breath, asthma, etc.)

Patients undergoing cochlear implantation: pregnant or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (during procedure - typically 1 hour in duration)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if stimulating a nerve in the ear with electricity during ear surgery can make the pupils get bigger.

Who is the study for?

This trial is for adults over 18 years old who are undergoing cochlear implantation or vagal nerve stimulator implantation and are willing to participate. It's not for those with a history of ear surgery, congenital malformations, pregnant/breastfeeding individuals, or anyone with certain medical conditions like heart arrhythmias, lung diseases, ulcers, dysautonomias, vasovagal syncope, or pre-existing hoarseness.

What is being tested?

The study tests how the pupil dilates when Arnold's Nerve (part of the vagus nerve) is stimulated with an electrical device during routine cochlear implant surgery. The aim is to understand the connection between this stimulation and changes in pupil size.

What are the potential side effects?

While specific side effects aren't listed for pupillary dilation from electrical stimulation in this context, potential risks may include discomfort at the stimulation site and typical surgical risks associated with cochlear implants or vagal nerve stimulators.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and getting a cochlear implant.

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I am scheduled for cochlear implant surgery.

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I am scheduled for a vagal nerve stimulator implantation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have lung diseases like asthma causing shortness of breath.

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I am not pregnant or breastfeeding if I am considering cochlear implantation.

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I do not have ulcers.

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I have had ear surgery, was born with an ear malformation, or have a cochlear implant.

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I am under 18 and getting a cochlear implant.

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I have had ear surgery, was born with an ear deformity, or have a cochlear implant.

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I am not receiving any other brain stimulation treatments.

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I do not have heart arrhythmias or other heart abnormalities.

Select...

I am under 18 and getting a vagal nerve stimulator implant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (during procedure - typically 1 hour in duration)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (during procedure - typically 1 hour in duration)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (during procedure - typically 1 hour in duration) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pupillary Dilation during Procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vagal Nerve Stimulation during Cochlear Implantation SurgeryExperimental Treatment1 Intervention

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

Group II: Vagal Nerve Stimulator ImplantationActive Control1 Intervention

Control cohort undergoing vagal nerve stimulator implantation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Electrical stimulator

2009

N/A

~110

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hearing loss, particularly those involving neuromodulation like vagal nerve stimulation (VNS), work by targeting the neural pathways associated with auditory processing. VNS, for example, involves stimulating the vagus nerve to modulate brain activity, which can potentially improve auditory function and reduce symptoms like tinnitus. This matters for hearing loss patients because such treatments aim to address the underlying neural dysfunctions that contribute to hearing loss, offering a non-invasive alternative to traditional hearing aids or surgical interventions. By improving neural plasticity and reducing maladaptive neural activity, these treatments can enhance auditory perception and overall quality of life for patients.

Too Blind to See the Elephant? Why Neuroscientists Ought to Be Interested in Tinnitus.Maladaptive plasticity in tinnitus--triggers, mechanisms and treatment.Acoustic Coordinated Reset Neuromodulation: A Systematic Review of a Novel Therapy for Tinnitus.