Opto-electrical Stimulation for Hearing Loss
(oCI Trial)
Trial Summary
What is the purpose of this trial?
Neural stimulation with photons has been proposed for a next generation of cochlear implants (CIs). The potential benefit of photonic over electrical stimulation is its spatially selective activation of small populations of spiral ganglion neurons (SGNs). Stimulating smaller neuron populations along the cochlea provides a larger number of independent channels to encode acoustic information. Hearing could therefore be restored at a higher fidelity and performance in noisy listening environments as well as music appreciation are likely to improve . While it has been demonstrated that optical radiation evokes auditory responses in animal models, it is not clear whether the radiant exposures used in the animal experiments are sufficient to stimulate the auditory system of humans. The proposed tests are: 1. to demonstrate that light delivery systems (LDSs) can be inserted and oriented optimally in the human cochlea. 2. to show that the LDSs are able to deliver sufficient amount of energy to evoke a compound action potential of the auditory nerve. 3. to validate that the fluence rate (energy / target area) required for stimulation is below the maximal fluence rate, which damaged the cochlea in animal experiments. 4. to show that combined optical and electrical stimulation is able to significantly lower the threshold required for optical stimulation in humans. The endpoints for the study are either the completion of the experiments proposed or the demonstration that not sufficient energy can be delivered safely in the human cochlea to develop an action potential.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Opto-electrical Cochlear Implants for hearing loss?
Is opto-electrical stimulation for hearing loss safe for humans?
How does the Opto-electrical Cochlear Implant treatment differ from other treatments for hearing loss?
The Opto-electrical Cochlear Implant treatment is unique because it uses light, rather than electricity, to stimulate the auditory nerve, allowing for more precise sound encoding and potentially better speech recognition in noisy environments compared to traditional electrical cochlear implants.1112131415
Research Team
Claus-Peter Richter, MD, PhD
Principal Investigator
Northwestern University
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Insertion of light delivery systems into the cochlea and measurement of auditory responses during tumor surgery
Follow-up
No follow-up required as per trial description
Treatment Details
Interventions
- Opto-electrical Cochlear Implants
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Central DuPage Hospital
Collaborator
University of Miami
Collaborator
University of Missouri-Columbia
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator