Degenerative Consequences of Congenital Deafness

Overview

In this study, the investigators will study one of the basic biophysical properties of the auditory nerve, charge integration, behaviorally (detection threshold versus phase duration functions). The investigators will compare charge integration in two subject groups: congenitally deafened and deafened at a later age in life. The investigators will then examine if behaviorally estimated neural excitation patterns differ between short phase duration and long phase duration stimulation. Lastly, The investigators will measure if speech recognition improves with using long phase duration stimulation, relative to using the standard default short phase duration stimulation. The primary endpoint of the study is speech recognition, and the secondary endpoints are the steepness of the detection threshold versus phase duration functions, and the width of psychophysically estimated neural excitation.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 4, 2023

Interventions

  • Behavioral: Phase duration
    • We will vary the phase duration in the stimulation, and examine detection threshold, spatial spread of neural excitation, and speech recognition as the outcomes.

Arms, Groups and Cohorts

  • Cochlear implant users with late-onset deafness
    • Examine charge integration (Detection threshold as a function of phase duration). Examine neural spatial excitation patterns with long and short phase duration. Measure speech recognition using long and short phase duration stimulation patterns.
  • Cochlear implant users with early-onset deafness
    • Examine charge integration (Detection threshold as a function of phase duration) and compare that with the late-onset group. Examine neural spatial excitation patterns with long and short phase duration within the non-leaky phase duration range. Measure speech recognition using long and short phase duration stimulation patterns.

Clinical Trial Outcome Measures

Primary Measures

  • Slope of the strength duration function
    • Time Frame: starting 6 months post award notice and will take up to 4 years to complete
    • Subjects will be measured for detection thresholds as a function of phase duration of the pulse train and the slope of the function will be derived.

Secondary Measures

  • Psychophysically estimated neural excitation width
    • Time Frame: starting 6 months post award notice and will take up to 4 years to complete
    • Subjects will be measured for psychophysical forward-masked spatial tuning curves using stimuli with long and short phase duration.
  • Speech recognition using long phase duration
    • Time Frame: starting 6 months post award notice and will take up to 4 years to complete
    • Subjects’ speech recognition performance will be evaluated using CUNY and TIMIT sentences with long and short phase duration stimulation.

Participating in This Clinical Trial

Inclusion Criteria

  • Cochlear Nucleus cochlear implant users or Advanced Bionics cochlear implant users – Native speakers of English – Early onset of deafness (< 3 years of age); no requirement for age at implantation – Late onset of deafness (> 3 years of age); matched in duration of deafness to the early onset group – Has had device experience for at least one year – Can be child or adult at the time of enrollment Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • East Carolina University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Heather Wright, Professor – East Carolina University

References

Hancock KE, Chung Y, Delgutte B. Congenital and prolonged adult-onset deafness cause distinct degradations in neural ITD coding with bilateral cochlear implants. J Assoc Res Otolaryngol. 2013 Jun;14(3):393-411. doi: 10.1007/s10162-013-0380-5. Epub 2013 Mar 5.

Hancock KE, Noel V, Ryugo DK, Delgutte B. Neural coding of interaural time differences with bilateral cochlear implants: effects of congenital deafness. J Neurosci. 2010 Oct 20;30(42):14068-79. doi: 10.1523/JNEUROSCI.3213-10.2010.

Hardie NA, Shepherd RK. Sensorineural hearing loss during development: morphological and physiological response of the cochlea and auditory brainstem. Hear Res. 1999 Feb;128(1-2):147-65. doi: 10.1016/s0378-5955(98)00209-3.

Leake PA, Snyder RL, Rebscher SJ, Moore CM, Vollmer M. Plasticity in central representations in the inferior colliculus induced by chronic single- vs. two-channel electrical stimulation by a cochlear implant after neonatal deafness. Hear Res. 2000 Sep;147(1-2):221-41. doi: 10.1016/s0378-5955(00)00133-7.

McKay CM. Forward masking as a method of measuring place specificity of neural excitation in cochlear implants: a review of methods and interpretation. J Acoust Soc Am. 2012 Mar;131(3):2209-24. doi: 10.1121/1.3683248.

Rattay F. Analysis of models for extracellular fiber stimulation. IEEE Trans Biomed Eng. 1989 Jul;36(7):676-82. doi: 10.1109/10.32099.

Sharma A, Gilley PM, Dorman MF, Baldwin R. Deprivation-induced cortical reorganization in children with cochlear implants. Int J Audiol. 2007 Sep;46(9):494-9. doi: 10.1080/14992020701524836.

Svirsky MA, Robbins AM, Kirk KI, Pisoni DB, Miyamoto RT. Language development in profoundly deaf children with cochlear implants. Psychol Sci. 2000 Mar;11(2):153-8. doi: 10.1111/1467-9280.00231.

Teoh SW, Pisoni DB, Miyamoto RT. Cochlear implantation in adults with prelingual deafness. Part II. Underlying constraints that affect audiological outcomes. Laryngoscope. 2004 Oct;114(10):1714-9. doi: 10.1097/00005537-200410000-00007.

Trune DR. Influence of neonatal cochlear removal on the development of mouse cochlear nucleus: I. Number, size, and density of its neurons. J Comp Neurol. 1982 Aug 20;209(4):409-24. doi: 10.1002/cne.902090410.

van den Honert C, Stypulkowski PH. Physiological properties of the electrically stimulated auditory nerve. II. Single fiber recordings. Hear Res. 1984 Jun;14(3):225-43. doi: 10.1016/0378-5955(84)90052-2.

Kong YY, Deeks JM, Axon PR, Carlyon RP. Limits of temporal pitch in cochlear implants. J Acoust Soc Am. 2009 Mar;125(3):1649-57. doi: 10.1121/1.3068457.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.