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Cochlear Implant Stimulation for Usher Syndrome

N/A
Recruiting
Led By Shuman He, MD, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with Usher syndrome or idiopathic hearing loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome measures will be obtained from day 1 through study completion, an average of 2 years.
Awards & highlights

Study Summary

This trial will evaluate local neural health and neural encoding of temporal and spectral cues in the cochlear nerve of implant patients with Usher syndrome, in order to develop evidence-based practice for managing these patients.

Who is the study for?
This trial is for individuals with Usher Syndrome or idiopathic hearing loss who have used a cochlear implant for at least 6 months. It's not suitable for those with severe medical conditions or issues with the position of their cochlear implant electrodes.Check my eligibility
What is being tested?
The study aims to understand how well the auditory nerve functions in patients with Usher Syndrome using cochlear implants by manipulating stimulation settings and measuring responses. It also seeks to develop a tool to assess the connection between electrodes and nerves.See study design
What are the potential side effects?
Since this trial involves non-invasive experimental adjustments to existing cochlear implants, direct side effects are minimal but may include discomfort from changes in sound perception during testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Usher syndrome or have hearing loss without a known cause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome measures will be obtained from day 1 through study completion, an average of 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome measures will be obtained from day 1 through study completion, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The electrically evoked compound action potential

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Usher SyndromeExperimental Treatment1 Intervention
Adult and pediatric cochlear implant users with Usher syndrome
Group II: Idiopathic Hearing LossActive Control1 Intervention
Adult and pediatric cochlear implant users with idiopathic hearing loss

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
505,576 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
330 Previous Clinical Trials
178,427 Total Patients Enrolled
Shuman He, MD, PhDPrincipal InvestigatorOhio State University

Media Library

Experimental manipulation of stimulation parameters (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04906135 — N/A
Usher Syndrome Research Study Groups: Usher Syndrome, Idiopathic Hearing Loss
Usher Syndrome Clinical Trial 2023: Experimental manipulation of stimulation parameters Highlights & Side Effects. Trial Name: NCT04906135 — N/A
Experimental manipulation of stimulation parameters (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04906135 — N/A
Usher Syndrome Patient Testimony for trial: Trial Name: NCT04906135 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the eligibility criteria for this experiment?

"This study will allow 44 people with cochlear implants to participate. Participants must be between 1 and 85 years old and have had their implant for at least 6 months."

Answered by AI

Does this research take into account octogenarians?

"According to the study's inclusion criteria, the minimum age requirement for participation is 1 year old and the maximum age is 85."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Tennessee
How old are they?
18 - 65
What site did they apply to?
The Ohio State University
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm hoping this clinical trial will help address my hearing loss and vision loss because of usher syndrome.
PatientReceived no prior treatments
I am 28 years old and was diagnosed with Usher syndrome type 2 in 2016. I have since then become night blind and recently been told that my vision is further deteriorating.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

When does the trial start?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Vanderbilt University Medical Center: < 48 hours
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Auditory Neural Function in Implanted Patients With Usher Syndrome
Shuman He 2021. "Auditory Neural Function in Implanted Patients With Usher Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04906135.
All > Usher Syndrome
~9 spots leftby Dec 2024
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