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Device

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

Must not have

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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My surgery will involve accessing the tumor through the inner ear.

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My tumor is larger than a marble.

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My tumor is near the facial nerve and surgery could damage it.

Exclusion Criteria

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

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I am unable to give consent for myself.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

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

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

Primary study objectives

Compound Action Potential (CAP)

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: 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

0 / 5Eligibility criteria met