NCT03867058

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

3.5 years

First QC Date

March 5, 2019

Last Update Submit

April 6, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

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

  • 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.

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

Secondary Outcomes (1)

  • Speech recognition

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

Study Arms (1)

Cochlear implant users with Nucleus and AB devices

Temporal 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.

Behavioral: Electrode selection/electrode configuration

Interventions

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

Cochlear implant users with Nucleus and AB devices

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Communication Sciences and Disorders, ECU

Greenville, North Carolina, 27834, United States

Location

Related Publications (24)

  • 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.

    PMID: 16270234BACKGROUND
  • 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.

    PMID: 21682414BACKGROUND
  • 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.

    PMID: 27317668BACKGROUND
  • 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.

    PMID: 18595189BACKGROUND
  • 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.

    PMID: 26501873BACKGROUND
  • 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.

    PMID: 26627764BACKGROUND
  • 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.

    PMID: 12243150BACKGROUND
  • 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.

    PMID: 17086076BACKGROUND
  • 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.

    PMID: 2993220BACKGROUND
  • 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.

    PMID: 16075190BACKGROUND
  • 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.

    PMID: 22367093BACKGROUND
  • 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.

    PMID: 24437773BACKGROUND
  • 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.

    PMID: 10675635BACKGROUND
  • 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.

    PMID: 20136187BACKGROUND
  • 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.

    PMID: 16708955BACKGROUND
  • Landsberger DM. Effects of modulation wave shape on modulation frequency discrimination with electrical hearing. J Acoust Soc Am. 2008 Aug;124(2):EL21-7. doi: 10.1121/1.2947624.

    PMID: 18681497BACKGROUND
  • Macherey O, Carlyon RP. Re-examining the upper limit of temporal pitch. J Acoust Soc Am. 2014 Dec;136(6):3186. doi: 10.1121/1.4900917.

    PMID: 25480066BACKGROUND
  • McDermott HJ, McKay CM. Musical pitch perception with electrical stimulation of the cochlea. J Acoust Soc Am. 1997 Mar;101(3):1622-31. doi: 10.1121/1.418177.

    PMID: 9069629BACKGROUND
  • McKay CM, McDermott HJ. Loudness perception with pulsatile electrical stimulation: the effect of interpulse intervals. J Acoust Soc Am. 1998 Aug;104(2 Pt 1):1061-74. doi: 10.1121/1.423316.

    PMID: 9714925BACKGROUND
  • Miller CA, Woo J, Abbas PJ, Hu N, Robinson BK. Neural masking by sub-threshold electric stimuli: animal and computer model results. J Assoc Res Otolaryngol. 2011 Apr;12(2):219-32. doi: 10.1007/s10162-010-0249-9. Epub 2010 Nov 16.

    PMID: 21080206BACKGROUND
  • Moore BC. Frequency difference limens for short-duration tones. J Acoust Soc Am. 1973 Sep;54(3):610-9. doi: 10.1121/1.1913640. No abstract available.

    PMID: 4754385BACKGROUND
  • Nilsson M, Soli SD, Sullivan JA. Development of the Hearing in Noise Test for the measurement of speech reception thresholds in quiet and in noise. J Acoust Soc Am. 1994 Feb;95(2):1085-99. doi: 10.1121/1.408469.

    PMID: 8132902BACKGROUND
  • Pijl S, Schwarz DW. Melody recognition and musical interval perception by deaf subjects stimulated with electrical pulse trains through single cochlear implant electrodes. J Acoust Soc Am. 1995 Aug;98(2 Pt 1):886-95. doi: 10.1121/1.413514.

    PMID: 7642827BACKGROUND
  • Thornton AR, Raffin MJ. Speech-discrimination scores modeled as a binomial variable. J Speech Hear Res. 1978 Sep;21(3):507-18. doi: 10.1044/jshr.2103.507.

    PMID: 713519BACKGROUND

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 7, 2019

Study Start

October 1, 2019

Primary Completion

April 4, 2023

Study Completion

April 4, 2023

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations