Hearing LossTFS4CIsNCT04708717
Encoding Temporal Fine Structure for Cochlear Implants
A study testing Stimulation Rate and Electrode Location in people with Hearing Loss and Cochlear Implants, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Cochlear Implants
- What is being tested?
- Stimulation Rate and Electrode Location
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cochlear implant users.
Who cannot join
- Younger than 18 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90033
Ray Goldsworthy, PhD, 213-222-3384, raymond.goldsworthy@med.usc.edu
About this study
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.
Read the 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.
- Conditions
- Hearing Loss, Cochlear Implants
- Being tested
- Stimulation Rate, Electrode Location
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation RateBehavioural
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 LocationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation Rate | Experimental | Not described Receives: Behavioral: Stimulation Rate; Behavioral: Electrode Location |
| Electrode Location | Active comparator | Not described Receives: Behavioral: Stimulation Rate; Behavioral: Electrode Location |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measure collected prior to training.
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.
Measured: Measure collected at 4-week midpoint during psychophysical training.
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.
Measured: Measure collected at 8-week endpoint following psychophysical training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Sep 2020
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, Ohio State University
- Responsible party
- Principal investigator, Raymond Goldsworthy, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708717
- Sponsor's protocol ID
- R01DC018044
- Acronym
- TFS4CIs
- Status last verified
- Jun 2025
- First submitted
- 7 Jan 2021
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encoding Temporal Fine Structure for Cochlear Implants
- ClinicalTrials.gov ID
- NCT04708717
- Acronym / sponsor ID
- TFS4CIs / R01DC018044
- Conditions
- Hearing Loss, Cochlear Implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of Rochester, Ohio State University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation Rate | Experimental | Behavioral: Stimulation Rate, Behavioral: Electrode Location |
| Electrode Location | Active comparator | Behavioral: Stimulation Rate, Behavioral: Electrode Location |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cochlear implant users.
Key exclusion criteria (1 listed)
- Younger than 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulation RatePsychophysical 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. | Behavioural | Electrode Location, Stimulation Rate |
| Electrode LocationPsychophysical 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. | Behavioural | Electrode Location, Stimulation Rate |
Primary outcome
Baseline electrode psychophysics prior to training.
Time frame: Measure collected 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.
Time frame: Measure collected at 4-week midpoint during psychophysical 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.
Endpoint electrode psychophysics.
Time frame: Measure collected at 8-week endpoint following psychophysical 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation Rate and Electrode Location in people with Hearing Loss and Cochlear Implants, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ray Goldsworthy, PhD (2132223384, raymond.goldsworthy@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline electrode psychophysics prior to training. (time frame: Measure collected prior to training.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.