Degenerative Consequences of Congenital Deafness

Congenital Deafness Clinical Trial

Official title:

Degenerative Consequences of Congenital Deafness

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03866850
• Other study ID #: Zhou_R01_study2
• Status: Terminated
• Start date: August 1, 2019
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Deafness
• Deafness
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Communication Sciences and Disorders, ECU	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Psychophysically estimated neural excitation width	Subjects will be measured for psychophysical forward-masked spatial tuning curves using stimuli with long and short phase duration.	starting 6 months post award notice and will take up to 4 years to complete
Secondary	Speech recognition using long phase duration	Subjects' speech recognition performance will be evaluated using CUNY and TIMIT sentences with long and short phase duration stimulation.	starting 6 months post award notice and will take up to 4 years to complete