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DeafnessNCT03867058

Tradeoff Between Spatial and Temporal Resolution

An observational study of Deafness, run by East Carolina University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

In this study, investigators will examine how temporal rate processing might be affected when the width of neural excitation narrows. The manipulation of neural excitation width will be achieved for example by changing electrode configurations or stimulating single versus multiple electrodes simultaneously. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Deafness
What is being tested?
Electrode selection/electrode configuration
How many people
53 participants
Where
1 siteUnited States
Study dates
1 Oct 2019to 4 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

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 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Children and adults received cochlear implants (Advanced Bionics and Cochlear Nucleus devices).

Who may be able to join

  • Native speakers of English
  • Cochlear Nucleus cochlear implant users or Advanced Bionics users
  • Postlingually deafened
  • Has had device experience for at least one year
  • Can be child or adult at the time of enrollment

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Department of Communication Sciences and Disorders, ECU

    Greenville, North Carolina, 27834

Other trials in United States

About this study

Official title: Tradeoff Between Spatial Resolution of Neural Excitation and Temporal Rate Processing

In this study, investigators will examine how temporal rate processing might be affected when the width of neural excitation narrows. The manipulation of neural excitation width will be achieved for example by changing electrode configurations or stimulating single versus multiple electrodes simultaneously. Investigators will then measure if the extent to which rate processing is affected by spatially restricted stimulation can predict a subject's overall speech recognition and predict also whether the subject is likely to benefit from a focused electrode configuration. Lastly, investigators will introduce and test a novel current focusing strategy where current focusing is applied in a channel specific manner and quantify if this intervention improves speech recognition. The primary endpoint of the study is speech recognition, and the secondary endpoint is psychophysical sensitivity to stimulation rate change.

Conditions
Deafness
Being tested
Electrode selection/electrode configuration
Medical subject headings
Deafness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrode selection/electrode configurationBehavioural

    Electrodes will be chosen based on their spatial tuning curves. Focused stimulation will be applied to electrodes with good temporal processing acuity.

Study groups in NCT03867058
Study groupRoleWhat they receive
Cochlear implant users with Nucleus and AB devicesTemporal processing acuity will be compared using electrodes or electrode configurations that create broad versus sharp spatial excitation. Speech recognition will be compared in the same group of subjects using electrode-dependent focused versus monopolar stimulation.
Receives: Behavioral: Electrode selection/electrode configuration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity to stimulation rate change at threshold

    Subjects' psychophysical detection thresholds will be measured as a function of the rate of stimulation delivered to selected electrodes and selected electrode configuration

    Measured: starting 6 months post award notice and will take up to 4 years to complete

  2. Discrimination of stimulation rate

    subjects' ability to discriminate stimulation rates will be measured as a function of base stimulation rates at selected electrodes and selected electrode configuration.

    Measured: starting 6 months post award notice and will take up to 4 years to complete

Secondary outcomes (1)

  1. Speech recognition

    Speech recognition in quiet and in noise will be measured under three conditions: 1. the traditional monopolar electrode configuration; 2. using current focusing on electrodes that show good sensitivity to rate change; 3. using current focusing on all electrodes.

    Measured: starting 6 months post award notice and will take up to 4 years to complete

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study start1 Oct 2019
  3. Primary completion4 Apr 2023
  4. Study completion4 Apr 2023

Why it stopped: PI passed away. Ending grant and closing lab.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03867058
Sponsor's protocol ID
Zhou_R01_study1
Status last verified
Apr 2023
First submitted
5 Mar 2019
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chatterjee M, Galvin JJ 3rd, Fu QJ, Shannon RV. Effects of stimulation mode, level and location on forward-masked excitation patterns in cochlear implant patients. J Assoc Res Otolaryngol. 2006 Mar;7(1):15-25. doi: 10.1007/s10162-005-0019-2. Epub 2005 Nov 4.

    PubMed 16270234

  • Nelson DA, Kreft HA, Anderson ES, Donaldson GS. Spatial tuning curves from apical, middle, and basal electrodes in cochlear implant users. J Acoust Soc Am. 2011 Jun;129(6):3916-33. doi: 10.1121/1.3583503.

    PubMed 21682414

  • Bierer JA, Litvak L. Reducing Channel Interaction Through Cochlear Implant Programming May Improve Speech Perception: Current Focusing and Channel Deactivation. Trends Hear. 2016 Jun 17;20:2331216516653389. doi: 10.1177/2331216516653389.

    PubMed 27317668

  • Berenstein CK, Mens LH, Mulder JJ, Vanpoucke FJ. Current steering and current focusing in cochlear implants: comparison of monopolar, tripolar, and virtual channel electrode configurations. Ear Hear. 2008 Apr;29(2):250-60. doi: 10.1097/aud.0b013e3181645336.

    PubMed 18595189

  • Boulet J, White M, Bruce IC. Temporal Considerations for Stimulating Spiral Ganglion Neurons with Cochlear Implants. J Assoc Res Otolaryngol. 2016 Feb;17(1):1-17. doi: 10.1007/s10162-015-0545-5.

    PubMed 26501873

  • Carlyon RP, Deeks JM. Combined neural and behavioural measures of temporal pitch perception in cochlear implant users. J Acoust Soc Am. 2015 Nov;138(5):2885-905. doi: 10.1121/1.4934275.

    PubMed 26627764

  • Carlyon RP, Deeks JM. Limitations on rate discrimination. J Acoust Soc Am. 2002 Sep;112(3 Pt 1):1009-25. doi: 10.1121/1.1496766.

    PubMed 12243150

  • Dingemanse JG, Frijns JH, Briaire JJ. Psychophysical assessment of spatial spread of excitation in electrical hearing with single and dual electrode contact maskers. Ear Hear. 2006 Dec;27(6):645-57. doi: 10.1097/01.aud.0000246683.29611.1b.

    PubMed 17086076

  • Eggermont JJ. Peripheral auditory adaptation and fatigue: a model oriented review. Hear Res. 1985 Apr;18(1):57-71. doi: 10.1016/0378-5955(85)90110-8.

    PubMed 2993220

  • Galvin JJ 3rd, Fu QJ. Effects of stimulation rate, mode and level on modulation detection by cochlear implant users. J Assoc Res Otolaryngol. 2005 Sep;6(3):269-79. doi: 10.1007/s10162-005-0007-6.

    PubMed 16075190

  • Green T, Faulkner A, Rosen S. Variations in carrier pulse rate and the perception of amplitude modulation in cochlear implant users. Ear Hear. 2012 Mar-Apr;33(2):221-30. doi: 10.1097/AUD.0b013e318230fff8.

    PubMed 22367093

  • Goldsworthy RL, Shannon RV. Training improves cochlear implant rate discrimination on a psychophysical task. J Acoust Soc Am. 2014 Jan;135(1):334-41. doi: 10.1121/1.4835735.

    PubMed 24437773

  • Javel E, Shepherd RK. Electrical stimulation of the auditory nerve. III. Response initiation sites and temporal fine structure. Hear Res. 2000 Feb;140(1-2):45-76. doi: 10.1016/s0378-5955(99)00186-0.

    PubMed 10675635

  • Kreft HA, Oxenham AJ, Nelson DA. Modulation rate discrimination using half-wave rectified and sinusoidally amplitude modulated stimuli in cochlear-implant users. J Acoust Soc Am. 2010 Feb;127(2):656-9. doi: 10.1121/1.3282947.

    PubMed 20136187

  • Kwon BJ, van den Honert C. Effect of electrode configuration on psychophysical forward masking in cochlear implant listeners. J Acoust Soc Am. 2006 May;119(5 Pt 1):2994-3002. doi: 10.1121/1.2184128.

    PubMed 16708955

Questions about this trial

What is this clinical trial studying?

An observational study of Deafness, run by East Carolina University 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 5 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: stopped early, as of the sponsor's last update on 7 Apr 2023. 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?

The study was stopped early (reason given: PI passed away. Ending grant and closing lab.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity to stimulation rate change at threshold (time frame: starting 6 months post award notice and will take up to 4 years to complete). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03867058, which also lists 24 linked publications.

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 7 Apr 2023.

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