Degenerative Consequences of Congenital Deafness

NCT03866850 | Terminated

• 1 other identifier: Zhou_R01_study2
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Deafness

Outcome Measures

Primary Outcomes (1)

• Slope of the strength duration function

  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.

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

Secondary Outcomes (2)

• Psychophysically estimated neural excitation width

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

• Speech recognition using long phase duration

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

Study Arms (2)

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.

Behavioral: Phase duration

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.

Behavioral: Phase duration

Interventions

Phase duration BEHAVIORAL

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

Cochlear implant users with early-onset deafness; Cochlear implant users with late-onset deafness

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

Department of Communication Sciences and Disorders, ECU

Greenville, North Carolina, 27834, United States

Location

Related Publications (12)

• 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.

  PMID: 23462803 BACKGROUND

• 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.

  PMID: 20962228 BACKGROUND

• 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.

  PMID: 10082295 BACKGROUND

• 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.

  PMID: 10962187 BACKGROUND

• 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.

  PMID: 22423717 BACKGROUND

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

  PMID: 2744791 BACKGROUND

• 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.

  PMID: 17828665 BACKGROUND

• 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.

  PMID: 11273423 BACKGROUND

• 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.

  PMID: 15454759 BACKGROUND

• 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.

  PMID: 7130465 BACKGROUND

• 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.

  PMID: 6480511 BACKGROUND

• 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.

  PMID: 19275322 BACKGROUND

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: August 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

US (1)