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Encoding Temporal Fine Structure for Cochlear Implants (TFS4CIs)

Primary Purpose

Hearing Loss, Cochlear Implants

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stimulation Rate
Electrode Location
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Cochlear implant users.

Exclusion Criteria:

  • Younger than 18 years.

Sites / Locations

  • University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stimulation Rate

Electrode Location

Arm Description

Outcomes

Primary Outcome Measures

Baseline electrode psychophysics prior to training.
Just-noticeable difference for pitch ranking based on stimulation cues. Pitch discrimination will be measured as provided independently by place and rate of cochlear implant stimulation, as well as in combination. Stimuli will be dual-electrode pulse trains, which probe place-pitch perception with greater resolution than possible with single-electrode stimulation. Two-alternative forced-choice procedures will be used in which participants judge which of two stimuli is higher in pitch. Frequency discrimination will be measured near condition frequencies of 110, 220, 440, 880, and 1760 Hz for each of the 4 stimulation conditions (place, rate, combined). Adaptive procedures will be used to measure 75% discrimination accuracy.
Midpoint electrode psychophysics.
Just-noticeable difference for pitch ranking based on stimulation cues. Pitch discrimination will be measured as provided independently by place and rate of cochlear implant stimulation, as well as in combination. Stimuli will be dual-electrode pulse trains, which probe place-pitch perception with greater resolution than possible with single-electrode stimulation. Two-alternative forced-choice procedures will be used in which participants judge which of two stimuli is higher in pitch. Frequency discrimination will be measured near condition frequencies of 110, 220, 440, 880, and 1760 Hz for each of the 4 stimulation conditions (place, rate, combined). Adaptive procedures will be used to measure 75% discrimination accuracy.
Endpoint electrode psychophysics.
Just-noticeable difference for pitch ranking based on stimulation cues. Pitch discrimination will be measured as provided independently by place and rate of cochlear implant stimulation, as well as in combination. Stimuli will be dual-electrode pulse trains, which probe place-pitch perception with greater resolution than possible with single-electrode stimulation. Two-alternative forced-choice procedures will be used in which participants judge which of two stimuli is higher in pitch. Frequency discrimination will be measured near condition frequencies of 110, 220, 440, 880, and 1760 Hz for each of the 4 stimulation conditions (place, rate, combined). Adaptive procedures will be used to measure 75% discrimination accuracy.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2021
Last Updated
October 25, 2022
Sponsor
University of Southern California
Collaborators
University of Rochester, Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04708717
Brief Title
Encoding Temporal Fine Structure for Cochlear Implants
Acronym
TFS4CIs
Official Title
Encoding Temporal Fine Structure for Cochlear Implants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
University of Rochester, Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Cochlear Implants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulation Rate
Arm Type
Experimental
Arm Title
Electrode Location
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Stimulation Rate
Intervention Description
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
Intervention Name(s)
Electrode Location
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline electrode psychophysics prior to training.
Description
Just-noticeable difference for pitch ranking based on stimulation cues. Pitch discrimination will be measured as provided independently by place and rate of cochlear implant stimulation, as well as in combination. Stimuli will be dual-electrode pulse trains, which probe place-pitch perception with greater resolution than possible with single-electrode stimulation. Two-alternative forced-choice procedures will be used in which participants judge which of two stimuli is higher in pitch. Frequency discrimination will be measured near condition frequencies of 110, 220, 440, 880, and 1760 Hz for each of the 4 stimulation conditions (place, rate, combined). Adaptive procedures will be used to measure 75% discrimination accuracy.
Time Frame
Measure collected prior to training.
Title
Midpoint electrode psychophysics.
Description
Just-noticeable difference for pitch ranking based on stimulation cues. Pitch discrimination will be measured as provided independently by place and rate of cochlear implant stimulation, as well as in combination. Stimuli will be dual-electrode pulse trains, which probe place-pitch perception with greater resolution than possible with single-electrode stimulation. Two-alternative forced-choice procedures will be used in which participants judge which of two stimuli is higher in pitch. Frequency discrimination will be measured near condition frequencies of 110, 220, 440, 880, and 1760 Hz for each of the 4 stimulation conditions (place, rate, combined). Adaptive procedures will be used to measure 75% discrimination accuracy.
Time Frame
Measure collected at 4-week midpoint during psychophysical training.
Title
Endpoint electrode psychophysics.
Description
Just-noticeable difference for pitch ranking based on stimulation cues. Pitch discrimination will be measured as provided independently by place and rate of cochlear implant stimulation, as well as in combination. Stimuli will be dual-electrode pulse trains, which probe place-pitch perception with greater resolution than possible with single-electrode stimulation. Two-alternative forced-choice procedures will be used in which participants judge which of two stimuli is higher in pitch. Frequency discrimination will be measured near condition frequencies of 110, 220, 440, 880, and 1760 Hz for each of the 4 stimulation conditions (place, rate, combined). Adaptive procedures will be used to measure 75% discrimination accuracy.
Time Frame
Measure collected at 8-week endpoint following psychophysical training.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cochlear implant users. Exclusion Criteria: Younger than 18 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ray Goldsworthy, PhD
Phone
2132223384
Email
raymond.goldsworthy@med.usc.edu
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray Goldsworthy, PhD
Phone
213-222-3384
Email
raymond.goldsworthy@med.usc.edu

12. IPD Sharing Statement

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Encoding Temporal Fine Structure for Cochlear Implants

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