Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (during procedure - typically 1 hour in duration)
Awards & highlights
Study Summary
This trial investigates how stimulating a nerve in the ear during surgery affects pupil size.
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.Check my eligibility
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.See study design
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 belowSelect...
I am over 18 and getting a cochlear implant.
Select...
I am scheduled for cochlear implant surgery.
Select...
I am scheduled for a vagal nerve stimulator implantation.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pupillary Dilation during Procedure
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
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,691 Total Patients Enrolled
14 Trials studying Hearing Loss
1,521 Patients Enrolled for Hearing Loss
J. Thomas Roland Jr.Principal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and getting a vagal nerve stimulator implant.You will be excluded if you have a history of fainting due to a medical condition.I am over 18 and getting a cochlear implant.I am scheduled for cochlear implant surgery.I am scheduled for a vagal nerve stimulator implantation.I do not have lung diseases like asthma causing shortness of breath.I am not pregnant or breastfeeding if I am considering cochlear implantation.I'm sorry, but the provided statement seems to be incomplete or unclear. It mentions the AANS exclusion criteria for VNS, but the specific exclusion criteria are not clearly stated. If you have the complete exclusion criteria, I can help simplify them for you.If you have certain medical conditions, such as dysautonomias, you may not be able to participate in the study, as determined by the AANS exclusion criteria for VNS.You have a medical condition that makes it unsafe for you to participate in the study, such as having pre-existing hoarseness.I do not have ulcers.I have had ear surgery, was born with an ear malformation, or have a cochlear implant.I am under 18 and getting a cochlear implant.I have had ear surgery, was born with an ear deformity, or have a cochlear implant.I am not receiving any other brain stimulation treatments.I do not have heart arrhythmias or other heart abnormalities.I am under 18 and getting a vagal nerve stimulator implant.
Research Study Groups:
This trial has the following groups:- Group 1: Vagal Nerve Stimulation during Cochlear Implantation Surgery
- Group 2: Vagal Nerve Stimulator Implantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots available in this medical experiment?
"Data from clinicaltrials.gov reveals that, while the initial posting of this medical trial occurred on May 22nd 2023 and it was last updated on May 12th 2023, recruitment is no longer taking place. However, many other trials are actively looking for participants at present - 172 to be exact."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger