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Opto-electrical Stimulation for Hearing Loss (oCI Trial)

N/A
Waitlist Available
Led By Claus-Peter Richter, MD, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requirement of the translabyrinthine approach for tumor removal
Tumor is larger than 2.5 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

oCI Trial Summary

This trial is testing whether a new way of stimulating the auditory nerve - using light instead of electricity - is safe and effective in humans. If successful, this could improve hearing for people with cochlear implants.

Who is the study for?
This trial is for adults who need surgery to remove a tumor near the facial nerve, which requires accessing the inner ear. They should have significant hearing loss (50 dB or more) and poor speech discrimination (50% or less). It's not open to those unable to consent, minors, pregnant women, prisoners, or vulnerable groups.Check my eligibility
What is being tested?
The study tests new cochlear implants that use light (photons) for potentially better hearing restoration. It aims to insert light delivery systems in the human cochlea safely and check if they can stimulate auditory nerves without damage. The trial also explores whether combining light with electrical stimulation lowers the energy needed.See study design
What are the potential side effects?
Potential side effects are not detailed but may include risks associated with inserting devices into the cochlea such as infection or damage to nearby structures within the ear. As this is an early-stage trial assessing feasibility and safety, close monitoring will occur.

oCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My surgery will involve accessing the tumor through the inner ear.
Select...
My tumor is larger than a marble.
Select...
My tumor is near the facial nerve and surgery could damage it.

oCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compound Action Potential (CAP)

oCI Trial Design

1Treatment groups
Experimental Treatment
Group I: electrical and optical hybrid stimulation stimulationExperimental Treatment3 Interventions
Patients with large tumors of the skull base, requiring a translabyrinthine craniotomy with sacrifice of their cochlea and vestibular system during the tumor resection may participate. A recording electrode will be placed on the round window, a cochleostomy will be created, and different Light delivery systems (LDSs) will be inserted into the cochlea. LDSs include angle polished optical fibers to determine the accuracy of the orientation of the radiation beam, and hybrid arrays of small optical sources and electrical contacts to evaluate electric-alone stimulation as a reference, and compare it to optic-alone and combined electrical and optical stimulation. Compound action potentials (CAPs) of the auditory nerve will be recorded.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
electrical stimulation
2014
Completed Early Phase 1
~700

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,201 Total Patients Enrolled
16 Trials studying Hearing Loss
2,006 Patients Enrolled for Hearing Loss
Central DuPage HospitalOTHER
13 Previous Clinical Trials
3,415 Total Patients Enrolled
University of MiamiOTHER
899 Previous Clinical Trials
409,702 Total Patients Enrolled
10 Trials studying Hearing Loss
972 Patients Enrolled for Hearing Loss

Media Library

Opto-electrical Cochlear Implants (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05110183 — N/A
Hearing Loss Research Study Groups: electrical and optical hybrid stimulation stimulation
Hearing Loss Clinical Trial 2023: Opto-electrical Cochlear Implants Highlights & Side Effects. Trial Name: NCT05110183 — N/A
Opto-electrical Cochlear Implants (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05110183 — N/A

Frequently Asked Questions

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

Is this experiment currently recruiting participants?

"The clinical trial that was first listed on April 1st, 2023 is no longer recruiting patients. The most recent update to this listing happened October 27th 2022. Despite the fact that this study has concluded recruitment, there are 155 other studies actively seeking participants."

Answered by AI

Is this research endeavor open to senior citizens?

"The accepted age range for this trial is 18 to 89 years old."

Answered by AI

To what extent is enrollment open for this medical trial?

"The trial is in search of 30 participants who are between 18-89 years old and have experienced hearing loss."

Answered by AI

Who else is applying?

What site did they apply to?
Central DuPage Hospital Association
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Opto-electrical Cochlear Implants
Claus-Peter Richter, MD, PhD 2024. "Opto-electrical Cochlear Implants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05110183.
All > Hearing Loss > Cochlear Implant
~20 spots leftby Dec 2025
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