- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03867058
Tradeoff Between Spatial and Temporal Resolution
April 6, 2023 updated by: Heather Wright, East Carolina University
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
53
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Greenville, North Carolina, United States, 27834
- Department of Communication Sciences and Disorders, ECU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children and adults received cochlear implants (Advanced Bionics and Cochlear Nucleus devices).
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
Electrodes will be chosen based on their spatial tuning curves.
Focused stimulation will be applied to electrodes with good temporal processing acuity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity to stimulation rate change at threshold
Time Frame: starting 6 months post award notice and will take up to 4 years to complete
|
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
Time Frame: starting 6 months post award notice and will take up to 4 years to complete
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech recognition
Time Frame: starting 6 months post award notice and will take up to 4 years to complete
|
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.
|
starting 6 months post award notice and will take up to 4 years to complete
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
April 4, 2023
Study Completion (Actual)
April 4, 2023
Study Registration Dates
First Submitted
March 5, 2019
First Submitted That Met QC Criteria
March 6, 2019
First Posted (Actual)
March 7, 2019
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
April 6, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Zhou_R01_study1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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