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Electrical Stimulation
Intraoperative Cochlear Nerve Stimulation for Acoustic Neuroma
N/A
Recruiting
Led By Harrison M Lin, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults with the diagnosis of unilateral or bilateral vestibular schwannoma proven on radiographic imaging.
Be older than 18 years old
Must not have
Women who are pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded immediately during ongoing cochlear-nerve stimulation
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if it is possible to stimulate the auditory system by placing an electrode next to the cochlear nerve.
Who is the study for?
This trial is for adults diagnosed with vestibular schwannoma, confirmed by imaging scans. It's specifically for those who have little to no hearing and are undergoing surgery to remove the tumor. Pregnant women cannot participate.
What is being tested?
The study is testing the possibility of stimulating the auditory system using an electrode that directly contacts the cochlear nerve during surgery for vestibular schwannoma.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, temporary changes in residual hearing, or altered sensation within the ear post-operation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor on my balance nerve confirmed by imaging tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recorded immediately during ongoing cochlear-nerve stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded immediately during ongoing cochlear-nerve stimulation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Auditory brainstem response
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intraoperative electrical stimulation of cochlear nerveExperimental Treatment1 Intervention
Electrical stimulation of the cochlear nerve will be tested intraoperatively in patients undergoing vestibular schwannoma resection.
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
560 Previous Clinical Trials
1,930,094 Total Patients Enrolled
Harrison M Lin, MDPrincipal InvestigatorUniversity of California, Irvine
John C Middlebrooks, PhDPrincipal InvestigatorUniversity of California, Irvine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe hearing loss and am scheduled for tumor surgery.I have a tumor on my balance nerve confirmed by imaging tests.I am currently pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Intraoperative electrical stimulation of cochlear nerve
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.
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