Encoding Temporal Fine Structure for Cochlear Implants

NCT ID: NCT04708717

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2026-04-01

Brief Summary

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The goal of this study is to improve music and speech perception for cochlear implant users. Presently, most cochlear implants discard the temporal fine structure of sound, which is information that is widely believed to contribute to both music and speech perception. The proposed work examines perceptual and physiological changes that occur once this information is provided to cochlear implant users in a clear and consistent manner.

Detailed Description

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The study goal is to improve music and speech perception for cochlear implant users. The relevant health outcome is their quality of life. This proposal focuses on how well cochlear implant users can learn to use temporal fine structure if provided as a clear and consistent cue for music or voice pitch. Historically, cochlear implants have discarded temporal fine structure and have only transmitted timing information of relatively slow envelope fluctuations. Attempts have been made to restore temporal fine structure into cochlear implant stimulation, but it is unclear whether previous attempts were limited by implementation, lack of experience, or inherently by physiology. The proposed approach is unique in that it examines the perceptual and physiological plasticity that occurs when temporal fine structure is restored. Proposed research is organized into two aims, which examine the relative salience of stimulation place and rate for providing a sense of pitch (Aim 1) and the salience of dynamic-rate stimulation compared to conventional methods (Aim 2). Both aims combine perceptual learning, computer-controlled electrode psychophysics, electrophysiology, and computational neural modeling to characterize the plasticity of pitch perception in cochlear implant users.

Aim 1 examines the perceptual and physiological plasticity associated with place and rate of cochlear implant stimulation. Cochlear implant users hear an increasing pitch associated with increasing stimulation rate, but this effect is difficult to measure above 300 Hz. Most studies of psychophysical sensitivity to cochlear implant stimulation rate have not considered perceptual learning. Preliminary results show that the sense of pitch provided by stimulation rate improves with training. The proposed research examines perceptual sensitivity and physiological encoding throughout a crossover training study with training provided for pitch based on place and rate of stimulation. The primary hypothesis tested is that cochlear implant users have a latent ability to hear pitch associated with stimulation rate, but they require training to learn how to use this new information.

Aim 2 is to determine whether dynamic-rate stimulation provides better sensitivity and better physiological encoding of fundamental frequency compared to conventional stimulation methods based on amplitude modulation of constant-rate stimulation. In normal physiology, auditory-nerve activity phase locks to the temporal fine structure of sound. Since cochlear implants typically discard this information, it is unknown how well cochlear implant users can learn to use it if provided. Aim 2 focuses on the comparison between dynamic-rate stimulation in which stimulation rate is dynamically adjusted to convey temporal fine structure compared to conventional methods based on amplitude modulation of constant-rate stimulation. The primary hypothesis is that dynamic-rate stimulation provides better pitch sensitivity and better physiological encoding compared to amplitude modulation of constant-rate stimulation.

Conditions

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Hearing Loss Cochlear Implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Stimulation Rate

Group Type EXPERIMENTAL

Stimulation Rate

Intervention Type BEHAVIORAL

Psychophysical training listening to stimulation rate as a cue for auditory pitch perception. The intervention is the listening rehabilitative exercises. Exercises are completed daily as 30-minute sessions for 2 weeks.

Electrode Location

Intervention Type BEHAVIORAL

Psychophysical training listening to electrode location as a cue for auditory pitch perception. The intervention is the listening rehabilitative exercises. Exercises are completed daily as 30-minute sessions for 2 weeks.

Electrode Location

Group Type ACTIVE_COMPARATOR

Stimulation Rate

Intervention Type BEHAVIORAL

Psychophysical training listening to stimulation rate as a cue for auditory pitch perception. The intervention is the listening rehabilitative exercises. Exercises are completed daily as 30-minute sessions for 2 weeks.

Electrode Location

Intervention Type BEHAVIORAL

Psychophysical training listening to electrode location as a cue for auditory pitch perception. The intervention is the listening rehabilitative exercises. Exercises are completed daily as 30-minute sessions for 2 weeks.

Interventions

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Stimulation Rate

Psychophysical training listening to stimulation rate as a cue for auditory pitch perception. The intervention is the listening rehabilitative exercises. Exercises are completed daily as 30-minute sessions for 2 weeks.

Intervention Type BEHAVIORAL

Electrode Location

Psychophysical training listening to electrode location as a cue for auditory pitch perception. The intervention is the listening rehabilitative exercises. Exercises are completed daily as 30-minute sessions for 2 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Cochlear implant users.

Exclusion Criteria

* Younger than 18 years.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Raymond Goldsworthy

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Southern California

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ray Goldsworthy, PhD

Role: CONTACT

2132223384

Facility Contacts

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Ray Goldsworthy, PhD

Role: primary

213-222-3384

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01DC018044

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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