Opto-electrical Cochlear Implants

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Northwestern University
Study ID
NCT05110183
Status
Enrolling By Invitation

Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • electrical stimulation — DEVICE
    A cochlear implant electrode will be inserted through a cochleostomy into scala tympani of the cochlear basal turn. Custom software on a laptop computer will be used to control the delivery of a sequence of charge balanced current pules.
  • optical stimulation — OTHER
    Optical fibers will be inserted through a cochleostomy into scala tympani of the cochlear basal turn. Custom software will be used to control the delivery of a sequence of charge balanced current pules.
  • combined optical and electrical stimulation — OTHER
    A short hybrid array consisting of optical sources and electrical contacts will be inserted through a cochleostomy into scala tympani of the cochlear basal turn. Biphasic electrical current pulse and optical pulse delivery will be controlled in amplitude and timing by a computer.

Study Details

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.

Key Dates

Start date
Apr 20, 2025
Status verified
May 2026
Primary completion
Dec 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: electrical and optical hybrid stimulation stimulation
    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.

Primary Outcome Measure

Compound Action Potential (CAP) [ Time Frame: 30 minutes ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of MiamiCoral GablesFlorida33146-
University of MissouriColumbiaMissouri65212-

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By research site
University of Miami· Coral Gables, FLUniversity of Missouri· Columbia, MO

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